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Study Objectives
This is a prospective, multi-center study to evaluate the diagnostic performance characteristics of the AminoIndex™ technology among patients at high risk for developing lung cancer as compared with standard lung cancer screening and diagnostic procedures including low-dose CT, high-dose CT, biopsy and histopathology.
Conditions: Lung Cancer
Intervention / Treatment:
| Inclusion Criteria
All Groups:
* Able to read, understand and sign informed consent to participate in study.
* Willing and able to provide written informed consent.
* Willing and able to meet all study requirements and undergo venipuncture to provide a fasting blood sample.
Group 1:
* Men or women age 18 years or older;
* Lung nodule size ≥ 6 mm but ≤ 35 mm/ lung, nodule or mass.
* Diagnosis of lung cancer based upon histopathology performed on lung nodule, lesion or mass tissue obtained from biopsy or surgical excision performed after study-related fasting blood sample obtained.
Group 2:
* Men or women age 18 years or older;
* Lung nodule size ≥ 6 mm but ≤ 35 mm/ lung nodule, lesion or mass;
* Definitive diagnosis of benign (non-cancerous) lung nodule based upon one of the following:
* Histopathology performed on lung nodule tissue obtained from biopsy or surgical excision performed after study-related fasting blood sample obtained;
* No nodule growth for > 2 years by repeat CT imaging, the most recent being performed within the 60 days prior to signing informed consent.
Group 3:
* Men or women age 55-79 years inclusive;
* Current smoker or quit < 15 years ago with a > 30 pack-year smoking history (equivalent of 1 pack per day for 30 or more years)\*.
* Have undergone low-dose computed tomography (LDCT) or standard computed tomography (CT) or X-ray testing to screen for lung cancer with no nodules suspicious for lung cancer within 1 year prior to signing informed consent.
' \* ' One pack year is calculated as follows: 20 cigarettes = 1 pack. One "pack year" is the equivalent of smoking:
* 20 cigarettes (one pack) per day for one year; or
* 40 cigarettes (two packs) per day for 6 months; or
* 60 cigarettes (three packs) per day for 3 months
Exclusion Criteria
* Inability to fast for 8 hours prior to the blood sample collection.
* Known to be positive for HIV and/or, HBV and/or HCV.
* Pregnancy.
* Breastfeeding.
* Currently undergoing dialysis.
* Congenital metabolic disease.
* Currently receiving investigational treatments of any type.
* History of receiving any drug therapy or surgery for the treatment of lung cancer.
* Diagnosis of cancer within past 5 years and/or currently undergoing treatment for any cancer.
* Any clinical condition, diagnosis, or social circumstance that, in the opinion of the Investigator, would be mean participation in the study would be contraindicated. | 15,176 |
Study Objectives
Open-label, dose-escalation study in subjects with previously treated B-cell malignancies to find maximum tolerated dose (MTD) or pharmacologic active dose of a PI3Kδ inhibitor, parsaclisib, as monotherapy and in combination with: itacitinib (INCB039110), a JAK1 inhibitor; rituximab; and rituximab, ifosfamide, carboplatin, and etoposide. Parsaclisib inhibits PI3Kδ, a protein involved in growth and survival of B-cell cancer cells.
Conditions: B-Cell Malignancies
Intervention / Treatment:
DRUG: Parsaclisib, DRUG: Itacitinib, DRUG: Rituximab, DRUG: Ifosfamide, DRUG: Carboplatin, DRUG: Etoposide
| Inclusion Criteria:
* Aged 18 years or older, with lymphoid malignancies of B-cell origin including:
1. Indolent / aggressive B-cell non-Hodgkin's lymphoma (NHL)
* EXCLUDING: Burkitt's lymphoma and precursor B lymphoblastic leukemia/lymphoma
* INCLUDING: any non-Hodgkin's B cell malignancy such as chronic lymphocytic leukemia (CLL) and rare non-Hodgkin's B- cell subtypes such as hairy cell leukemia, Waldenström macroglobulinemia (WM), mantle cell leukemia (MCL), and transformed NHL histologies
2. Hodgkin's lymphoma (HL)
* Life expectancy of 12 weeks or longer
* Subject must have received ≥ 1 prior treatment regimen(s)
* The subject must not be a candidate for potentially curative therapy including hematopoietic stem cell transplantation, except where one of the standard therapy regimen combinations may be used prior to transplantation per standard medical practice
Exclusion Criteria:
* Has history of brain metastasis, spinal cord compression (unless treated, asymptomatic, and stable on most recent imaging and enrolling in expansion cohort), or lymphoma involving the central nervous system (CNS)
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of ≥ 3 (≥ 2 during dose escalation)
* Received allogeneic hematopoietic stem cell transplant within the last 6 months, or has active graft versus host disease (GVHD) following allogeneic transplant, or currently receiving immunosuppressive therapy following allogeneic transplant
* Received autologous hematopoietic stem cell transplant within the last 3 months
* Inadequate marrow reserve assessed by hematologic laboratory parameters
* Inadequate renal or liver function
* Known HIV infection, or hepatitis B virus (HBV) or hepatitis C virus (HCV) viremia or at risk for HBV reactivation | 30,433 |
Study Objectives
The purpose of this study is to treat patients with locally advanced or metastatic NSCLC with a combination therapy of selumetinib and two different doses of docetaxel 75mg/m2 or 60 mg/m2 vs placebo and compare how well each dose affects how their cancer responds. It will also help us to understand the tolerability profile of the different dosing regimens in these patients
Conditions: Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV
Intervention / Treatment:
DRUG: Selumetinib 75 mg, DRUG: Docetaxel 75 mg/m2, DRUG: Docetaxel 60 mg/m2, DRUG: Placebo
| Inclusion Criteria:
* Provision of signed, written and dated informed consent prior to any study specific procedures
* Male or female, aged 18 years or older
* Histological or cytological confirmation of locally advanced or metastatic NSCLC (IIIB-IV)
* Prospective confirmation of KRAS mutation negative status as determined via an AZ approved laboratory
* Failure of 1st line anti-cancer therapy due to radiological documentation of disease progression in advanced disease or subsequent relapse of disease following 1st line therapy
Exclusion Criteria:
* Mixed small cell and non-small cell lung cancer histology
* Received >1 prior anti-cancer drug regimen for advanced or metastatic NSCLC. Patients who develop disease progression while on switch maintenance therapy (maintenance using an agent not in the first-line regimen) will not be eligible.
* Other concomitant anti-cancer therapy agents except steroids
* Prior treatment with a MEK (Mitogen-Activated Protein Kinase) inhibitor or any docetaxel-containing regimen (prior treatment with paclitaxel is acceptable)
* The last radiation therapy within 4 weeks prior to starting study treatment, or limited field of radiation for palliation within 7 days of the first dose of study treatment. | 13,160 |
Study Objectives
This is a multicentre, non-interventional, prospective study to be carried out in representative hospitals in order to assess 1st line treatment management and diagnostic approaches applied to ovarian, peritoneal and fallopian tube cancer management in Russia and assess patients' characteristics and the occurrence of BRCA (Breast Cancer gene) mutations among Russian women with serous and endometrioid ovarian, peritoneal and fallopian tube cancer. No additional procedures besides those already used in the routine clinical practice will be applied to the patients. Treatment assignment will be done according to the current practice.
Conditions: Ovarian, Peritoneal, Fallopian Tube Cancer, BRCAm+ in Russia
Intervention / Treatment:
| Inclusion Criteria:
* The voluntary obtained informed consent signed by both the subject and the investigator.* Confirmed serous and endometrioid ovarian cancer or fallopian tube cancer or peritoneal cancer diagnosed 3 months before enrolment into the study or later* Patients on treatment for OC (Ovarian Cancer) or FTC (Fallopian Tube Cancer) or PC (Peritoneal Cancer)
Exclusion Criteria:
* The ovarian cancer histology other than serous and endometrioid.* Patients participating in clinical studies.* Any medical condition which on the opinion of the investigator may interfere the patient's participation in the trial. | 29,674 |
Study Objectives
This is an open-label, multicenter, phase 2 study of lurbinectedin monotherapy in participants with advanced (metastatic and/or unresectable) solid tumors.
Conditions: Advanced Solid Tumor, Metastatic Solid Tumor, Urothelial Cancer, Poorly Differentiated Neuroendocrine Carcinomas, Homologous Recombination Deficient-Positive Malignancies Agnostic
Intervention / Treatment:
DRUG: Lurbinectedin
| Inclusion Criteria:
* Signed informed consent* ≥ 18 years of age* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1* Adequate organ and bone marrow function* Has measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.* Have advanced (metastatic/unresectable) cancers in one of the following:
1. Histologically or cytologically confirmed urothelial cancer
2. Histologically or cytologically confirmed poorly differentiated neuroendocrine carcinoma
3. Histologically or cytologically confirmed homologous recombination deficient-positive malignancies agnostic, which may include endometrial, biliary tract, urothelial, breast (TNBC or HR+HER2- breast cancer), pancreas, gastric, or esophageal solid tumors with preidentified germline and/or somatic pathogenic mutation* Adequate contraceptive precautions
Exclusion Criteria:
* Known symptomatic central nervous system (CNS) metastasis requiring steroids* History of prior malignancy within 2 years of enrollment* Clinically significant cardiovascular disease* Active infection requiring systemic therapy* Significant non-neoplastic liver disease* Prior treatment with trabectedin or lurbinectedin* Treatment with an investigational agent within 4 weeks of enrollment* Received live vaccine with 4 weeks of first dose* Prior allogeneic bone marrow or solid organ transplant* Positive hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening* Positive human immunodeficiency virus (HIV) infection at screening | 31,040 |
Study Objectives
The prognosis of patients with obstructive jaundice caused by hepatocellular carcinoma (HCC) is dismal even after biliary drainage; due to malfunction of the biliary drainage tube caused by hemobilia and/or tumor emboli. Photodynamic therapy (PDT) in hilar cholangiocarcinoma improves biliary drainage and prolongs survival. The aims of this study were to assess the safety and efficacy of PDT in unresectable HCC with bile duct invasion.
Conditions: Hepatocellular Carcinoma, Obstructive Jaundice
Intervention / Treatment:
DRUG: Photofrin
| Inclusion Criteria:
* Known HCC: Diagnosis of HCC based on the 2005 AASLD (American Association for the Study of Liver Diseases) practice guidelines
* Unresectable HCC: Determined based on the BCLC (Barcelona-Clinic-Liver-Cancer) staging and treatment system
* Bile duct invasion of HCC: Confirmed by pathology via endoscopic retrograde cholangiopancreatogram (ERCP) or percutaneous transhepatic biliary drainage (PTBD). In case pathological diagnosis is clinically impossible, confirmed by dynamic CT or MRI showing that typical arterial enhancing mass in dilated bile duct and previous HCC diagnosis.
Exclusion Criteria:
* Severe renal disease
* Severe cardiac disease
* Bleeding tendency
* Porphyria | 22,130 |
Study Objectives
The purpose of this clinical study is to confirm the efficacy and safety of the Kyphon®Xpede™ Bone Cement in human use in China.
Conditions: Pathological Fracture of Vertebra Due to Secondary Osteoporosis (Disorder), Pathological Fracture of Vertebra Due to Neoplastic Disease (Disorder)
Intervention / Treatment:
DEVICE: Xpede™ Bone Cement, DEVICE: Mendec Spine Bone Cement
| Inclusion Criteria:
* Subject being diagnosed as having painful pathological vertebral body fracture, who is suitable for VP/BKP procedure (1-3 levels) according to clinic practice.* Subjects who are willing to participate in study through consent and willing to undergo study specific required procedures with expectancy of geographically stable for follow up duration.* Subjects are at least 18 and ≤80 years old .
Exclusion Criteria:
* Subject has a local or systemic infection.* Subject has pains caused by other spine disease than painful pathological vertebral compression fracture.* Subject has a medical condition with less than 1 year of life expectancy.* Subject is grossly obese, i.e. BMI≥40.* Subject has medical conditions that represent contraindications for the use of bone cement by investigator's decision.* Subject has an allergy or an intolerance to bone cement component.* Subject has past spinal surgeries at the target level(s) for which the VP/BKP procedure is suitable.* Subjects who are currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when document pre-approval is obtained from the Medtronic study manager and Medtronic Medical Advisor.* Pregnant women or breastfeeding women, or women of child bearing potential who are not on a reliable form of birth regulation method or abstinence.* Subjects with exclusion criteria required by local law (age or other).* Subjects with medical condition which precludes them from participation in the opinion of the Investigator. | 29,466 |
Study Objectives
The purpose of this research study is to learn if and in what amount a compound from hops, called xanthohumol (ZAN-tho-HUE-mol), prevents damage to DNA and oxidative stress. The human body is constantly exposed to oxidative stress from environmental compounds (e.g. air pollution) which may cause damage to DNA. The human body can repair some DNA damage, but too much DNA damage is harmful and may lead to cancer. Research done at OSU and around the world has shown that xanthohumol can stop or slow processes that lead to cancer.
Conditions: Oxidative Stress
Intervention / Treatment:
DRUG: 6 mg xanthohumol per day, DRUG: 12 mg xanthohumol per day, DRUG: 24 mg xanthohumol per day, DRUG: Placebo
| Inclusion Criteria:
* Non-smokers or no other tobacco use in the past 3 months.
* Willing to stop taking regular supplements including anti-oxidants for 2 weeks prior to study entry through conclusion of study.
* Willing to stop consumption of high levels of flavonoids and xanthohumol in the normal diet (onions, teas including green/black tea and microbrew beers) for 2 weeks prior to study entry through conclusion of study.
* Must be able to give written informed consent.
* Blood screen tests (Comprehensive metabolic profile \[CMP\] and lipid profile) within normal limits.
Exclusion Criteria:
* Body Mass Index (BMI) less than 18.5 (underweight) or greater than 30 (obese)
* Have a significant acute or chronic coexisting illness such as cardiovascular disease, chronic kidney or liver disease, gastrointestinal disorder, endocrinological disorder, immunological disorder, metabolic disease, cancer, history of chemotherapy, celiac disease or gluten/wheat intolerance\*, diabetes, thyroid problems, or any condition which contraindicates, in the investigators judgement, entry into the study.
* Currently taking prescription drugs except oral contraceptives.
* Consumption of more than the recommended alcohol guidelines i.e. >2 drinks/day.
* Consumption of high levels of flavonoids and xanthohumol in the normal diet (onions, teas including green/black tea and microbrew beers).
* Pregnancy (as confirmed by urine pregnancy test), breastfeeding, or planning to become pregnant before completing the study.
* Undergoing UV therapy (e.g. treatment for skin conditions such as psoriasis), using UV tanning beds, or unprotected sun exposure greater than 1 hour per day.
* Engaging in vigorous exercise more than 6 hours per week.
* Participation in another dietary study in the past 3 months.
* Had surgery in the last 3 months.
* Post-menopausal status
(\*Note: Beverage is formulated with a barley extract. Barley contains gluten.) | 32,200 |
Study Objectives
To assess the efficacy of ZD6474 in combination with docetaxel in the treatment of ABC using the progression event count methodology
Conditions: Advanced Breast Cancer
Intervention / Treatment:
DRUG: Vandetanib (ZD6474), DRUG: Docetaxel
| Inclusion Criteria:
* Females with histological/cytological confirmation of breast cancer.
* Subjects with a measurable lesion or bone lesions
Exclusion Criteria:
* Previous radiotherapy within 6 weeks
* Significant cardiac events, arrhythmias or other cardiac conditions | 13,185 |
Study Objectives
The purpose of this study is to determine if RRx-001, which is added on to the cisplatin and radiation treatment, reduces the duration or length of severe oral mucositis in patients with head and neck cancers. All patients in this study will receive 7 weeks of standard of care radiation therapy given with the chemotherapy agent, cisplatin. Patients in arms 1, 2 and 3 will also receive RRx-001 on different schedules.
Conditions: Oral Mucositis
Intervention / Treatment:
DRUG: RRx-001, DRUG: Cisplatin for injection, RADIATION: Radiation Therapy
| Inclusion Criteria:
* Pathologically confirmed diagnosis of squamous cell carcinoma (SCC) of the oral cavity and oropharynx Note: Patients with unknown primary tumors whose treatment plan matches the requirements specified in Inclusion Criterion #3 below are eligible for the trial* Treatment planned to include standard cisplatin monotherapy administered either every three weeks (100 mg/m2 for 3 doses) with concomitant radiation delivered as a continuous course of IMRT with single daily fractions of 2.0 to 2.2 Gy with a cumulative radiation dose between 60 Gy and 72 Gy. Planned radiation treatment fields must include at least two oral sites (buccal mucosa, floor of mouth, tongue, soft palate) that are each planned to receive a total of > 55 Gy. Patients who have had prior surgery are eligible, provided they have fully recovered from surgery, and patients who may have surgery in the future are eligible.* ECOG performance status ≤ 2.* Participants must have adequate organ and marrow function as defined below:
A. Absolute neutrophil count (ANC) >1,500 / mm3 B. Platelets > 100,000 / mm3 C. Hemoglobin ≥ 9.0 g/dL* Adequate renal and liver function as indicated by:
A. Serum creatinine acceptable for treatment with cisplatin per institutional guidelines) B. Total bilirubin ≤ 1.5 x upper-normal limit (ULN) C. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN D. Alkaline phosphatase ≤ 2.5 x ULN* Human papilloma virus (HPV) status in tumor has been documented using tumor immunohistochemistry for HPV-p16 or other accepted test for patients with cancers of the oropharynx, base of tongue, or unknown primary.* Age 18 years or older* Patient must consent to the access, review and analysis of previous medical and cancer history, including imaging data by the sponsor or a third party nominated by the sponsor.* Ability to understand and sign a written informed consent document.* Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.
Note: A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
* Has not undergone a hysterectomy or bilateral oophorectomy; or
* Has not been postmenopausal for at least 12 consecutive months* Adequate visual access to permit examination of the following oral cavity sites: lips, buccal mucosa, floor of mouth, ventral and lateral tongue and soft palate.
Exclusion Criteria:
* Prior radiation to the head and neck* Tumor of the lips, nasopharynx, hypopharynx, larynx, or salivary glands* Patients with simultaneous primaries or bilateral tumors* Metastatic disease (M1) Stage IV* Malignant tumors other than HNC within the last 5 years, unless treated definitively and with low risk of recurrence in the judgment of the treating investigator* Presence of oral mucositis (WHO Score ≥ Grade 1) or other oral mucosal ulceration at study entry* Grade 3 or 4 dysphagia or odynophagia (National Cancer Institute Common Toxicity Criteria, version 5.0) or inability to eat a normal diet* Requirement at baseline for parenteral or gastrointestinal tube-delivered nutrition for any reason* Known history of HIV or active hepatitis B/C (patients who have been vaccinated for hepatitis B and do not have a history of infection are eligible)* Any significant medical diseases or conditions, as assessed by the investigators and sponsor that would substantially increase the medical risks of participating in this study (i.e., uncontrolled diabetes, NYHA II-IV congestive heart failure, myocardial infarction within 6 months of study, severe chronic pulmonary disease or active uncontrolled infection, uncontrolled or clinically relevant pulmonary edema).* Pregnant or nursing* Untreated active oral or dental infection, including severe tooth decay (caries)* Known allergies or intolerance to cisplatin and similar platinum-containing compounds* Evidence of immediate life-threatening disease or a life expectancy of less than 3 months* Receipt of unapproved or off-label medication within 30 days prior to start of study treatment* Sjogren syndrome | 10,562 |
Study Objectives
A Phase 2, clinical study in advanced, metastatic breast cancer that will evaluate CX-2009 monotherapy in both Hormone Receptor(HR) positive/HER2 negative breast cancer and in TNBC, and evaluate CX-2009+CX-072 in TNBC
Conditions: Neoplasms, Breast Neoplasms, Breast Neoplasms, Triple-Negative, Breast Cancer, Breast Neoplasms, Hormone Receptor Positive/HER2 Negative
Intervention / Treatment:
DRUG: CX-2009, DRUG: CX-072
| INCLUSION CRITERIA:
* Arm A: inoperable, locally advanced or metastatic HR-positive/HER2-negative breast cancer. Patients must have received 0 to 2 prior cytotoxic chemotherapy in the inoperable, locally advanced, or metastatic setting
* Arm B and Arm C: inoperable, locally advanced or metastatic TNBC; archival or fresh tumor tissue must have high CD166 expression by immunohistochemistry (IHC). Patients must have received 1 - 3 prior lines of therapy for inoperable, locally advanced, or metastatic TNBC
* Arm C only: Patients must be Programmed Death Ligand 1 (PD-L1) positive by an FDA-approved test. For patients who have received prior checkpoint inhibitors (CPI) therapy: if the CPI was the most recent treatment given prior to enrollment into this study, the patient must not have progressed within 120 days of the first dose of the CPI
* Measurable disease per RECIST v1.1
* Adults, at least 18 years of age
* Eastern Cooperative Oncology Group performance status of 0 or 1
* Adequate baseline Laboratory Values
* Patients of childbearing potential or those with partners of childbearing potential must agree to use a highly effective method of birth control at least 1 month prior to first dose, during study treatment, and for a period of 50 days after the last dose of CX-2009 and 105 days after the last dose of CX-072 (Arm C).
* Patients with brain metastases that are ≤ 1 cm, are asymptomatic, and require no treatment may be eligible after discussion with Medical Monitor.
* Additional inclusion criteria may apply
EXCLUSION CRITERIA:
* History of malignancy that was active within the previous 2 years. Exceptions include localized cancers that are not related to the current cancer being treated, that are considered to have been cured, and in the opinion of the Investigator present a low risk for recurrence
* Untreated symptomatic brain and/or leptomeningeal metastases
* Unresolved prior therapy-related acute toxicity Grade > 1, including neuropathy. Alopecia and other nonacute toxicities are not exclusionary
* Active or chronic corneal disorder
* Serious concurrent illness
* History of allogeneic tissue/solid organ transplant, stem cell transplant, or bone marrow transplant
* Arm C only:
* History of or current active autoimmune diseases
* History of myocarditis regardless of the cause
* History of intolerance to prior immune CPI therapy defined as the need to discontinue treatment due to an immune-related Adverse Event (AE)
* Immunosuppressive therapy including chronic systemic steroid (≥ 10 mg daily prednisone equivalents) within 14 days of Cycle 1 Day 1 (C1D1). However, patients who require brief courses of steroids (eg, as prophylaxis for IV contrast or for treatment of an allergic reaction) may be eligible with Medical Monitor approval. Inhaled or topical steroids are permitted.
* History of severe allergic or anaphylactic reactions to previous monoclonal antibody (mAb) therapy or known hypersensitivity to any component of Probody therapeutic
* Prior treatment with maytansinoid-containing drug conjugates (eg, DM1 or DM4 antibody drug conjugate, including trastuzumab emtansine)
* Pregnant or breastfeeding
* Additional exclusion criteria may apply | 10,026 |
Study Objectives
Capecitabine is a chemotherapy drug used to treat many types of cancer including bowel and stomach cancer. Unfortunately a side effect of this drug is that it causes heart problems including heart attacks. An alternative drug, called teysuno is used extensively in other countries instead of capecitabine and appears to have less of a bad effect on the heart whilst still killing cancer cells. This study will investigate the effect of these two drugs on the heart and blood vessels and will be the first of its kind in humans.
Conditions: Gastrointestinal Cancer, Cancer of Unknown Primary Site, Pancreatic Cancer, Bile Duct Neoplasms
Intervention / Treatment:
DRUG: Teysuno, DRUG: Capecitabine
| Inclusion Criteria:
* Male or female patients at least 18 years or over with no upper age limit.
* Confirmed advanced or metastatic oesophageal, gastric, gastro-oesophageal, small bowel, colorectal, hepatobiliary or pancreatic cancer or cancer of unknown primary.
* Suitable for treatment with fluoropyrimidine, either alone or in combination with oxaliplatin.
* WHO performance status (PS) 0, 1 or 2 and considered by responsible consultant to be fit to undergo planned chemotherapy and cardiac investigations.
* Baseline laboratory tests (within 1 week prior to starting treatment):
* Neutrophils >1.5 x109 /L and platelet count > 100 x109 /L
* Serum bilirubin <1.5 x upper limit of normal (ULN), alkaline phosphatase <5x ULN, and serum transaminase (either AST or ALT) <3 x ULN
* Estimated glomerular filtration rate (eGFR) >30 mL/min (Patients with eGFR 30-50 mL/min will be included but should be treated at a reduced dose (see master prescription chart).
* For women of childbearing potential; negative pregnancy test and adequate contraceptive precautions.
* Effective contraception for male patients if the risk of conception exists.
* Written informed consent for participation in the trial.
Exclusion Criteria:
* Patients who are unfit for the chemotherapy regimens in this protocol, such as:
* Known intolerance to CAP or other FPs
* Severe uncontrolled concurrent medical illness likely to interfere with protocol treatments
* Poorly controlled angina or MI in previous 6 months
* Any psychiatric or neurological condition which is felt likely to compromise the patient's ability to give informed consent or to comply with oral medication
* Partial or complete bowel obstruction
* Pre-existing neuropathy > grade 1 if combination therapy proposed
* Patients on therapeutic anticoagulation (warfarin or LMWH).
* Patients unable to lie flat.
* Patients unable to withstand the visits and cardiovascular investigations proposed within the study. | 34,353 |
Study Objectives
Myeloproliferative disorders occur in families, thus giving rise to the theory that it is a genetic disease that may be caused by an abnormal gene in the DNA that can be passed from one generation of family members to another. DNA can be gathered from family members through blood samples and the investigators will investigate (through DNA testing) to see if there are abnormal genes that may be responsible for causing the MPDs. Understanding which genes are responsible for causing MPDs can help develop ways to identify people who may be at risk for developing an MPD, allow for the development of better treatments, possibly a cure, or even prevent the development of MPDs.
Conditions: Polycythemia Vera, Essential Thrombocythemia, Idiopathic Myelofibrosis
Intervention / Treatment:
| Inclusion Criteria:
* Families with 2 or more members diagnosed with polycythemia vera (PV), essential thrombocythemia (ET), PV and ET related myelofibrosis (PV-MF and ET-MF), idiopathic myelofibrosis (IM) or chronic myelogenous leukemia (CML).
* Healthy family members of subjects diagnosed with a myeloproliferative neoplasm (MPN).
* Participating subjects must be 7 years of age or older
* A written assent, parental permission or consent must be obtained prior to any study procedures being performed.
Exclusion Criteria:
* Subjects who have a known acquired cause of polycythemia (increased hemoglobin/hematocrit), such as people living in high altitudes (in excess of 14,000 feet), subjects with heart disease, left to right heart shunt, severe hypoxia, cyanotic congenital heart disease, or severe pulmonary disease, will be excluded from this study, secondary forms of thrombocytosis and secondary forms of myelofibrosis. | 388 |
Study Objectives
The purpose of this study is to determine if sorafenib (sorafenib tosylate) is a safe and effective treatment option for preventing liver cancer in high risk patients following liver transplantation. Liver transplantation is a treatment option for liver cancer patients, but despite transplantation, the liver cancer can recur in the new, transplanted liver. It is not known whether sorafenib is effective in preventing cancer recurrence in high risk patients following liver transplantation
Conditions: Adult Primary Hepatocellular Carcinoma, Localized Resectable Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer, Recurrent Adult Primary Liver Cancer
Intervention / Treatment:
DRUG: sorafenib tosylate, OTHER: placebo, OTHER: laboratory biomarker analysis
| Inclusion Criteria:
* Patients must have hepatocellular carcinoma (HCC) with one of the following on explant: microvascular/macrovascular invasion, tumor outside of Milan criteria, poor tumor differentiation; patients with macrovascular invasion on explant pathology will be stratified
\* Additionally, the following will be included
\*\* Patients with elevated surrogate markers (AFP > 500 or PIVKA > 400) pre transplant and with biopsy proven HCC prior to orthotopic liver transplantation (OLT) or on explant
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
* Patients with a life expectancy > 12 weeks
* Patients must have completed prednisone taper within 6 weeks post OLT
* Patients must be enrolled between 6 to 12 weeks post OLT
* Cadaveric donors only (no living donor liver transplantation \[LDLT\] or donor after cardiac death transplantation \[DCDT\])
* No sorafenib prior to inclusion in the study
* Platelet count > 50 x 10\^9/L
* Hemoglobin >= 8.5 g/dL
* Total bilirubin =< 5 mg/dL
* Alanine transaminase (ALT) and aspartate aminotransferase (AST) =< 5 x upper limit of normal
* Amylase and lipase =< 1.5 x the upper limit of normal
* Serum creatinine < 2 x the upper limit of normal
* Prothrombin time (PT) =< 6 seconds or international normalized ratio (INR) =< 2.3
* AFP > 500 (pre-transplant)
* PIVKA > 400 (pre-transplant)
* Patient has not received prior anti-angiogenic therapy, systemic targeted agents or systemic chemotherapy
\* Prior surgical resection, chemoembolization or other local therapy prior to transplant is permitted
* Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug; post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test
* Patients (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the informed consent form (ICF) until at least 30 days after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate
* Patient must be able to swallow and retain oral medication
* Patient must exhibit the ability to understand and willingness to sign a written informed consent regarding the study and alternative treatments
Exclusion Criteria:
* Significant ongoing immunologic rejection based on pathology and clinical diagnosis (from time of transplant until randomization)
* Use of T cell depleting agents for prevention or treatment of rejection at any point prior to or after enrollment in the study
* Patient with documented evidence of metastatic disease
* 100% tumor necrosis on explant pathology
* Use of mammalian target of rapamycin (mTOR) inhibitors prior to transplant and as post-transplant immunosuppression
* Use of alemtuzumab
* Living donor liver transplant (LDLT) or donation after cardiac death transplant (DCDT)
* Human immunodeficiency virus (HIV) positive patients
* Hepatitis C virus (HCV) recurrence at the time of randomization
* Use of direct acting antivirals for HCV recurrence
* Requirement of re-transplantation for primary non function
* Uncontrolled hypertension, defined as systolic blood pressure > 140 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management
* Active or clinically significant cardiac disease including:
* Congestive heart failure - New York Heart Association (NYHA) > class II
* Coronary artery disease
* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin
* Unstable angina or new-onset angina within 3 months before randomization, or myocardial infarction (MI) within 6 months before randomization
* Clinically active serious infection documented by positive cultures or an incomplete course of treatment for bacteremia or fungemia
* Evidence or history of bleeding diathesis or coagulopathy
* Patients with any pulmonary hemorrhage/bleeding event grade 2 or higher within 4 weeks before randomization
* Patients with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks \[TIAs\]) within 6 months before randomization
* Prior use of raf-kinase inhibitors (sorafenib), vascular endothelial growth factor (VEGF) inhibitors, mitogen-activated protein kinase (MAPK)/extracellular-signal-related kinase (ERK) kinase (MEK) inhibitors, or farnesyl transferase inhibitors
* Patients using cytochrome P450 3A4 (CYP3A4) inducers (eg, phenytoin, carbamazepine, phenobarbital, St. John's Wort dexamethasone) at a dose of greater than 16 mg daily, or rifampin and/or rifabutin within 28 days before randomization
* Patients with non-HCC malignancy except those with DCIS (ductal carcinoma in situ), cervical cancer in-situ, basal cell or superficial bladder tumor; patients surviving a cancer that was curatively treated and without evidence of recurrence for more than 3 years before randomization are allowed
* Presence of a non-healing wound, non-healing ulcer, or bone fracture
* Known or suspected allergy or hypersensitivity to any of the study drugs, study drug classes, or excipients of the formulations given during the course of this trial
* Any malabsorption condition
* Women who are pregnant or breast-feeding
* Inability to comply with the protocol and/or not willing or not available for follow-up assessments
* Patients with fibrolamellar HCC, cholangiocarcinoma, and combined HCC-cholangiocarcinoma
* Any condition which, in the investigator's opinion, makes the patient unsuitable for trial participation
* Prior use of any systemic chemotherapy for HCC
* Prior use of systemic investigational agents for HCC
* Prior use of raf-kinase inhibitors (sorafenib), VEGF inhibitors, MEK inhibitors or farnesyl transferase inhibitors
* Use of biologic response modifiers, such as granulocyte colony-stimulating factor (G-CSF), will not be permitted within 3 weeks prior to study entry; G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity, such as febrile neutropenia, when clinically indicated or at the discretion of the investigator; however, they may not be administered to prevent a dose reduction; patients taking chronic erythropoietin are permitted, provided no dose adjustment is undertaken within 1 month prior to randomization or during the study
* Autologous bone marrow transplant or stem cell rescue within four months of start of study drug
* Concomitant treatment with rifampin and St. John's wort
* Concomitant oral mTOR inhibitor treatment
* Use of direct acting antivirals for HCV recurrence
* Use of T-cell depleting agents
* Use of alemtuzumab
* Anticoagulation, as described below, is allowed:
* Vitamin-K antagonists (e.g., warfarin)
\*\* Low dose warfarin (1 mg orally, once daily) with PT-INR =< 1.5 x ULN is permitted; patients taking concomitant warfarin should be monitored regularly for changes in PT, PT-INR or clinical bleeding episodes
* Low dose aspirin (=< 100 mg daily).
* Heparins and heparinoids Use of any other investigational drug | 22,193 |
Study Objectives
This was a non-interventional observational study within the routine chronic myeloid leukemia treatment practice; no further tests were required apart from the assessments routinely performed for Chronic myeloid leukemia patients treated with nilotinib.
Conditions: Chronic Myeloid Leukemia
Intervention / Treatment:
OTHER: Nilotinib
| Inclusion Criteria:
* Adult patients diagnosed with Ph+ CML (or evidence of BCR-ABL transcript) treated with nilotinib under routine medical practice and the SmPC, as amended, in first or any subsequent line, if the current therapy with nilotinib has not been in place for more than twelve months. Retrospective documentation of patients for up to one year will be permitted.
* Patients who have already had an interruption/discontinuation of nilotinib therapy.
* Patients who have been informed about this NIS and have personally dated and signed their informed consent form.
Exclusion Criteria:
* There are no exclusion criteria, apart from the contraindications mentioned in the SmPC. Participating patients are not allowed to take part in a clinical trial in parallel, | 37,648 |
Study Objectives
The purpose of this study is to assess the safety and efficacy in Korea or Taiwan of oral abiraterone acetate and oral prednisolone in men with metastatic-castration resistant prostate cancer (mCRPC) and with disease progression following treatment with a docetaxel-containing chemotherapy.
Conditions: Prostate Cancer
Intervention / Treatment:
DRUG: Abiraterone acetate, DRUG: Prednisolone
| Inclusion Criteria:
* Histologically or cytologically confirmed adenocarcinoma of the prostate (stage IV)
* Has documented Prostate Specific Antigen (PSA) progression according to protocol-specific prostate specific antigen working group (PSAWG) eligibility criteria
* Has undergone prior chemotherapy for prostate cancer with regimen(s) containing Docetaxel
* Has an ongoing androgen deprivation with serum testosterone less than 50 ng/dL
* Has not received radiotherapy, chemotherapy, or immunotherapy at least 30 days prior to the treatment
* Eastern Cooperative Oncology Group Performance Status less than or equal to 2
Exclusion Criteria:
* Active or uncontrolled autoimmune disease that may require corticosteroid therapy
* Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
* Uncontrolled hypertension
* Hemoglobin less than or equal to 9.0 g/dL independent of transfusion
* Has abnormal liver function tests
* Surgery or local prostatic intervention within 30 days of the first dose | 31,564 |
Study Objectives
The purpose of this study is to assess the safety and tolerability of AG013 (genetically modified L. lactis bacteria engineered to secrete human Trefoil Factor 1), and to explore the ability of AG013 to attenuate the course and severity of oral mucositis (OM) in subjects receiving induction chemotherapy for the treatment of head and neck cancer.
Conditions: Oral Mucositis
Intervention / Treatment:
BIOLOGICAL: AG013, BIOLOGICAL: AG013, BIOLOGICAL: AG013, OTHER: Placebo, OTHER: Placebo, OTHER: Placebo
| Inclusion Criteria:
* Willing and able to understand and sign the study specific Informed Consent Form (ICF) approved by the site's Institutional Review Board
* Males or females 18 years or older
* Recently diagnosed with pathologically-confirmed squamous cell carcinoma of the head and neck (e.g., oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, lips, sinuses, salivary glands, unknown primary)
* Planned to receive at least two cycles of induction chemotherapy of the same regimen consisting of cisplatin/fluorouracil (PF) or cisplatin/fluorouracil/docetaxel (PFT). The planned CT cycles must be of the same length and must be a minimum of 14 days in length
* Karnofsky performance score ≥ 60%
* Screening laboratory assessments:
* Hemoglobin ≥ 10g/dl
* White blood count ≥ 3500 cells/mm3
* Absolute neutrophil counts ≥ 1500 cells/ mm3
* Direct bilirubin ≤ 2x upper limit of normal (ULN)
* Serum AST and ALT ≤ 3 x ULN
* Serum creatinine ≤ 2 mg/dl
* Serum pregnancy test: negative for females of childbearing potential: A women is considered to be of child bearing potential unless she has had a tubal ligation or is postmenopausal (without a menstrual period for at least one year)
* Subjects of childbearing potential must agree to utilize effective contraceptive methods of birth control during study participation and for 30 days following the last treatment with IMP
* Have documented mouth pain during CT Cycle 1 (i.e., OMDQ question 2 score of ≥ 2 during CT Cycle 1)
Exclusion Criteria:
* Prior radiation to the head and neck
* Chemotherapy within 21 days prior to study start
* Presence of active infectious disease excluding oral candidiasis
* Current use of antibiotic rinses or troches
* Alcohol abuse syndrome; recovered alcoholics may be included
* Presence of OM (WHO Grade > 0)
* Chronic immunosuppression
* Known seropositive for HIV or hepatitis B or C
* Use of investigational agent within 30 days of signing informed consent
* Teeth extractions within 7 days prior to the start of CT administration
* Female subjects who are pregnant or nursing
* Known sensitivity to any investigational agent
* Inability to give informed consent or comply with study requirements
* Unwilling or unable to complete subject diary
* Any other clinical condition, psychiatric condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable or to comply with follow-up visits | 19,264 |
Study Objectives
This phase II trial is studying how well giving imatinib mesylate together with decitabine works in treating patients with accelerated or blast phase chronic myelogenous leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving imatinib mesylate together with decitabine may kill more cancer cells
Conditions: Accelerated Phase Chronic Myelogenous Leukemia, Blastic Phase Chronic Myelogenous Leukemia, Childhood Chronic Myelogenous Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Relapsing Chronic Myelogenous Leukemia
Intervention / Treatment:
DRUG: imatinib mesylate, DRUG: decitabine, OTHER: laboratory biomarker analysis
| Inclusion Criteria:
* Histologically confirmed chronic myelogenous leukemia
* Philadelphia chromosome positive by cytogenetics OR fluorescent in situ hybridization
* Accelerated or non-lymphoid blastic phase
* Performance status - ECOG 0-2
* Bilirubin no greater than 2 times upper limit of normal (ULN)
* AST no greater than 2 times ULN
* Creatinine less than 2.0 mg/dL
* Normal cardiac function
* No New York Heart Association class III or IV heart disease
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior decitabine
* At least 2 weeks since other prior chemotherapy (unless there is evidence of rapidly progressive disease) and recovered
* Concurrent hydroxyurea allowed during the first 2 courses of study therapy in patients with rapidly progressing disease
* Prior imatinib mesylate allowed
* Patients who received at least 4 weeks of prior imatinib mesylate must have failed therapy, as evidenced by resistance after 8 weeks or disease progression
* No concurrent grapefruit or grapefruit juice | 17,963 |
Study Objectives
This is a Phase 1 trial of TLX591, a monoclonal antibody HuX591 conjugated with a DOTA chelator and radiolabelled with 177Lu (177Lu-DOTA-TLX591). TLX591 is being developed as a PSMA-targeting antibody to be radiolabelled with a therapeutic radiosotope for the treatment of PSMA-expressing tumours, therefore this study has been designed to assess the safety and tolerability, pharmacokinetics, whole body biodistribution and radiation dosimetry of 177Lu-DOTA-TLX591.
Conditions: Metastatic Prostate Cancer
Intervention / Treatment:
BIOLOGICAL: 177Lu-DOTA-TLX591
| Inclusion Criteria:
* Be male, at least 18 years old, with histologically/pathologically confirmed metastatic adenocarcinoma.
* Be of ECOG Performance Status 0, 1, or 2 and have an estimated life expectancy of ≥ 6 months.
* Have metastatic disease (≥1 metastatic lesions present on baseline whole body CT, MRI, or bone scintigraphy).
* Have castration-resistant PC (defined as disease progressing despite castration by orchiectomy or ongoing use of luteinizing hormone-releasing hormone \[LHRH\] agonists) and must have a castrate level of serum/plasma testosterone (< 50 ng/dL or <1.7 nmol/L).
* In the mCRPC setting, must have received a minimum of 12 weeks of prior therapy with a NAAD, either enzalutamide or abiraterone plus prednisone.
* Have received one line of prior taxane therapy, or have refused or are ineligible for taxanes
* Have disease that is progressing at study entry, despite a castrate testosterone level (<50 ng/dL or <1.7 nmol/L), by the demonstration of at least one of the following:
1. Increase in PSA greater than 25% and > 2 ng/mL above nadir, confirmed by progression at 2 timepoints at least 3 weeks apart.
2. Progressive disease or new lesion(s) (relative to previous imaging) in the viscera or lymph nodes as per RECIST1.1 or in bone as per Prostate Cancer Working Group 3 \[PCWG3). Any ambiguous results are to be confirmed by additional imaging modality (e.g., CT, Tc-99m bone scintigraphy)
* Have disease which is PSMA positive, as demonstrated by a 68Ga-PSMA-11 PET/CT or \[18F\]DCFPyL PET/CT scan and confirmed as eligible by local reader (patient must have at least one site of metastatic disease with SUVmax ≥1.5 times the SUV of normal liver). If the disease meets the criteria for PSMA positivity, but there is one or more soft tissue lesion of ≥2 cm that is not PSMA positive, then the patient is to be excluded on the grounds that there is substantial disease which might not respond to the therapy.
* Must have recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapies (i.e., surgery, local radiotherapy, NAAD, chemotherapy, etc.).
* Can be receiving a bisphosphonate or denosumab regimen provided tolerance to this therapy has been proven.
11. Have adequate organ function at Screening:
a. Bone marrow: i. Platelets ≥150×109/L ii. Absolute neutrophil count >1.5×109/L iii. Hemoglobin ≥10g/dL (no red blood cell transfusion in the previous 4 weeks) b. Liver function: i. Total bilirubin ≤1.5×the upper limit of normal (ULN). For patients with known Gilbert's Syndrome ≤3×ULN is permitted ii. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3×ULN OR ≤5×ULN for patients with liver metastases c. Renal function: i. Serum/plasma creatinine ≤1.5×ULN or creatinine clearance ≥50 mL/min
* Have the capacity to understand the study and be able and willing to comply with all protocol requirements.
* Must comply with the radiation protection guidelines (including hospital admissions and isolation) that are applied by the treating institution in order to protect their contacts and the general public.
* Must agree to practice adequate precautions to prevent pregnancy in a partner and to avoid potential problems associated with radiation exposure to the unborn child (Refer to Clinical Trials Facilitation Group, 2020: Recommendations related to contraception and pregnancy testing in clinical trials Version 1.1, CTFG, 2020).
Exclusion:
* Are unable, in the opinion of the Investigator, to understand or are unwilling to sign a written informed consent document or to follow investigational procedures.
* Have PC with pathological findings consistent with small cell or any histology other than adenocarcinoma of the prostate. If there are minor elements of neuroendocrine histology, this is acceptable.
* Experiencing uncontrolled pain
* Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. Patients with a prior history of malignancy that has been adequately treated and who have been disease-free for more than 3 years are eligible, as are patients with adequately treated non-melanoma skin cancer, and superficial bladder cancer.
* At increased risk of hemorrhage, or with a recent history of a thrombotic event (e.g., deep vein thrombosis \[DVT\]/ pulmonary embolism \[PE\]) and/or are using long-term anti-coagulant or anti-platelet agents.
* Have received prior administration of monoclonal antibody (mAb) J591 or HuJ591 or any other PSMA targeted therapy.
* Have known allergies, hypersensitivity, or intolerance to the investigational drug or its excipients.
* Have received systemic anti-cancer therapy (e.g., chemotherapy, immunotherapy, or biological therapy) and/or radiation therapy within 4 weeks of enrollment OR if any significant AEs have not resolved to National Cancer Institute (NCI) AE Criteria ≤2; OR are receiving other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.
* Have received prior treatment with radiopharmaceuticals containing, but not limited to, the following radioisotopes: 89Strontium, 153Samarium, 186Rhenium, 188Rhenium, 223Radium; or have received hemi-body irradiation within 6 months prior to randomization.
* Have received other investigational agents within 4 weeks of randomization.
* Have known brain metastases (any size) or hepatic metastases > 1 cm.
* Have a history of seizure and/or stroke within past 6 months.
* Have clinical or radiologic findings indicative of impending cord compression or experiencing symptomatic cord compression.
* Have a serious active or sub-clinical infection, or angina pectoris or heart failure (New York Heart Association \[NYHA\] Class III or IV), significantly prolonged QT interval or other serious illness(es) involving the cardiac, respiratory, central nervous, renal, hepatic or hematological organ systems, which might impair the ability to complete this study or could interfere with determination of causality of any adverse effects experienced in this study, or which require treatment that could interact with study treatment.
* Have received treatment with any PARP inhibitors (i.e., Olaparib) or with any platinum based anti-neoplastic drugs.
* Have a known alteration in breast cancer genes (BRCA) BRCA1, BRCA2, or Ataxia Telangiectasia Mutated Gene (ATM) gene and are eligible to receive Olaparib therapy according to their treating institution SoC. | 37,245 |
Study Objectives
We retrospectively looks at the impact of the margin status and its size in mm on the recurrence rate in colo-rectal liver metastasis surgery.
Conditions: Colorectal Cancer Stage IV
Intervention / Treatment:
| Inclusion Criteria:
* Primary colorectal cancer with liver metastasis
* Undergone liver surgery at our center between 2011 and 2015
* Pathological reports with margin status available (or specimen still available for measurement)
Exclusion Criteria:
* Repeat liver resection No tissu or incomplete pathological information | 24,138 |
Study Objectives
The aim of the study was to evaluate the therapeutic action through the diameter of the lesion, of low level laser (LLL) associated to photodynamic therapy (PDT) in oral mucositis (OM) lesions, in young patients. A randomized clinical trial blinded, split-mouth was performed. The study sample consisted of 15 cancer patients (3-16 years old) of Aldenora Bello Hospital (São Luís, Maranhão, Brazil). Random allocation by lot of treatments (PDT + LLL and LLL) to quadrants of the oral cavity was performed, and the patient was his own control. Patients were masked about therapy performed on each side of the arch. The evaluation period of both therapeutic regimens was 8 days, and the outcome assessed was the lesion size (measured in cm²). Friedman and Wilcoxon tests were applied and the effect magnitude calculated. The significance level was 5%. Statistically significant difference was observed between the groups for the lesion diameter of the 6th to the 8th day (greater regression of lesion size for the PDT + LLL group), which was confirmed by a difference magnitude moderated. Based on the findings, it is concluded that PDT + LLL showed greater therapeutic effect when compared to LLL in reducing the severity of OM lesions.
Conditions: Oral Mucositis
Intervention / Treatment:
OTHER: PDT + Low level laser, RADIATION: Low level laser
| Inclusion Criteria:
* Patients between 3 and 18 years old
* Patients on chemotherapy inductive phase
* Patients with oral mucositis and bilateral lesions
Exclusion Criteria:
* Patients outside the established age
* Patients who are in other phases of chemotherapy
* Patients who did not have bilateral lesions | 5,189 |
Study Objectives
The primary purpose of this study to determine if AZD2281 is effective and well tolerated in maintaining the improvement in your cancer after previous platinum-based chemotherapy
Conditions: Ovarian Cancer
Intervention / Treatment:
DRUG: AZD2281, DRUG: matching placebo
| Inclusion Criteria:
* Female patients with histologically diagnosed serous ovarian cancer or recurrent serous ovarian cancer.
* Patients must have completed at least 2 previous courses of platinum containing therapy; the patient must have been platinum sensitive to the penultimate chemo regimen.
* For the last chemotherapy course prior to enrolment on the study, patients must have demonstrated an objective stable maintained response (partial or complete response) and this response needs to be maintained until completion of chemotherapy.
* Patients must be treated on the study within 8 wks of completion of their final dose of the platinum containing regimen.
Exclusion Criteria:
* Previous treatment with PARP inhibitors including AZD2281
* Patients with low grade ovarian carcinoma.
* Patients who have had drainage of their ascites during the final 2 cycles of their last chemotherapy regimen prior to enrolment on the study
* Patients receiving any chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study entry (or a longer period depending on the defined characteristics of the agents used). | 36,931 |
Study Objectives
This study evaluates the effectiveness of an experimental proposal therapy for upper limb lymphedema secondary to breast called Activity-oriented proprioceptive antiedema therapy (TAPA) facing the consensual gold standard treatment, the complete decongestive therapy. TAPA consists in:
* Health education / patient empowerment.
* Neurodynamic activities oriented to Activities of Daily Living (ADL).
* Proprioceptive neuromuscular facilitation exercises oriented to ADL.
* Self-adherent self-adhesive antiedema of low compression.
Half of patients will receive TAPA treatment while the other half will receive CDT standard treatment.
Conditions: Breast Cancer Lymphedema, Post-Mastectomy Secondary Lymphedema
Intervention / Treatment:
OTHER: Activity-oriented Proprioceptive Antiedema Therapy (TAPA), OTHER: Complete Decongestive Therapy (CDT)
| Inclusion Criteria:
* Upper limb lymphedema secondary to breast cancer grade I and II, according to the Working Group of the XI International Lymphology Congress
Exclusion Criteria:
* Upper limb lymphedema secondary to breast cancer grade 0 and III, according to the Working Group of the XI International Lymphology Congress | 4,450 |
Study Objectives
This study is a validation study to confirm the ability of Telomescan OBP-401 to identify CTCs in patients with HPV 16 / 18 associated cervical cancer. CTCs identified will be tested for the presence of the HPV 16 / 18 E6 protein, confirming a cervical cancer origin.
Conditions: Cervical Cancer, HPV
Intervention / Treatment:
DIAGNOSTIC_TEST: Blood Assayed for CTCs
| Inclusion Criteria:
* Able to safely provide 15 ml of blood
* Able to provide informed consent
* Pathologically confirmed invasive cervical cancer
* Proof of serotype HPV 16 or HPV 18 positive within 3 years of the study
* Patients with stages IIA2 to IVB OR recurrent cervical cancer
* For patients with newly diagnosed cervical cancer, they must be enrolled (blood drawn) prior to initiating anti-cancer therapy
* For patients with recurrent cervical cancer, they must be enrolled (blood drawn) prior to initiating a new anti-cancer therapy for progression of disease (based on RECIST 1.1 criteria). Patients who have progressed and are moving to best supportive care are eligible.
* If patients meet criteria 5.1A 5 above, the following criteria must be met:
* At least 21 days have elapsed following treatment with cytotoxic chemotherapy
* At least 14 days have elapsed following treatment with biologic therapy
* At least 14 days have elapsed following radiation therapy
Exclusion Criteria:
* History of any cancer other than cervix cancer within the past five years.
* History of any known germ-line pathogenic mutation (ie BRCA 1 / 2 or Lynch syndrome, but genetic testing is not required)
* Current use of systemic corticosteroids at doses exceeding 10 mg per day of prednisone or its equivalent.
* Active infection including hepatitis B, hepatitis C, HIV.
* Any patient unable to comply with the study criteria.
* Patients taking any anti-inflammatory agents (aspirin, NSAIDs, steroids), within 24 hrs prior to blood draw. | 34,753 |
Study Objectives
The treatment of large-cell B-cell lymphomas refractory to more than 2 lines of therapy has recently been revolutionized by the use of immunotherapies consisting of autologous genetically modified cells or CAR-T CELLS (chimeric antigen receptor-T cells), which very significantly increase progression-free survival and overall survival. Nevertheless, this therapy is frequently associated with cytokine release syndrome and in approximately 20% to 60% of patients with neurological complications that can sometimes be dramatic and are associated with a significant mortality rate.
The mechanisms behind this neurotoxicity are unclear.
Despite the frequent occurrence of neurological toxicity characterized in particular by headache, tremor, and encephalopathy that is most often transient, brain imaging by CT or, preferably, MRI are most often normal. The rare abnormalities that have been identified suggest the presence of cytotoxic edema associated with the existence of transient modifications of the blood-brain barrier.
To date, the management of neurotoxicity associated with CAR-T CELLS remains empirical. It combines early management of cytokine release syndrome (by administration of anti-IL6) and treatment with corticosteroids, the objective of which would be to control neurotoxicity more specifically. A better understanding of the pathophysiological mechanisms associated with this neurotoxicity appears essential today in order to be able to propose adapted prevention and treatment methods.
Main objectives are to compare tissue permeability by quantitative MRI measurement of Ktrans to the theoretical peak of neurotoxicity between patients with CAR-T Cell-induced neurotoxicity and those without neurotoxicity and to Study, by MRI, the evolution of tissue microcirculatory parameters (from D-3 to D7) between groups of patients with or without the occurrence of neurotoxicity associated with CAR-T CELL treatment.
For this purpose, 25 subjects will be included (the investigators hypothesize 40% with treatment-induced neurological impairment).
Conditions: Lymphoma, B-Cell, Neurotoxicity
Intervention / Treatment:
OTHER: Magnetic Resonance Imaging with contrast injection, OTHER: Blood withdrawal, OTHER: Neuropsychological tests
| Inclusion Criteria:
* Subject aged from 18 years old
* Subject able to understand the nature, purpose and methodology of the study
* Subject with diffuse large B-cell lymphoma to be treated with axicabtagene ciloleucel, tisagenlecleucel or brexucabtagene autoleucel for their lymphoma.
Exclusion Criteria:
* Refusal to sign the informed consent
* Subject presenting a cerebral localization of his lymphoma
* Contraindication to the realization of an MRI (metallic foreign body, pace-maker, cochlear implants)
* Claustrophobic subject
* Subject with a neurodegenerative disease (Parkinson's, Alzheimer's...)
* Subject with psychiatric disorders such as psychosis, except for anxiety-depressive episodes
* Subject with a systemic pathology with neurological manifestation
* Subject with a previous or evolving neurological pathology
* Subject with or with a history of severe head trauma (group 2 or 3 according to the Masters classification)
* Contraindication to the use of gadoline contrast products (severe renal insufficiency, liver transplantation, known or suspected hypersensitivity to the product)
* Pregnant or breastfeeding women
* Patient under tutelage
* Patient under curatorship
* Patient deprived of liberty
* Not a beneficiary of a social security system | 26,904 |
Study Objectives
Despite considerable advances in cancer treatment, patients with locally advanced lung cancer still face a poor chance of survival and a high risk of experiencing serious, life threatening treatment-related side-effects. These side-effects are poorly understood and difficult to measure: it is therefore challenging to design new treatment strategies aiming to decrease treatment toxicity and yet increase survival. At present, many patients present with tumours so large that only a low palliative dose of radiation therapy can be offered in order to keep the risk of side-effects to an acceptable level. In this project, named INHALE, the possibility of irradiating lung cancer patients while they hold their breath in deep inspiration (so called: Deep inspiration breath hold, or DIBH) will be investigated. In DIBH, the healthy lung tissue is pushed away from the tumour, and even when a large tumour is present, a high curative dose of radiation therapy can be offered. This technique is simple and is widely used to treat breast cancer patients in our institution as well as in other centres in the world. If positive, results from INHALE can be transferred easily and with minimal costs throughout Denmark and the rest of the world.
DIBH has only sporadically been used in lung cancer patients to date, because of the assumption that this patient group, often having a poor performance status, could not comply with DIBH procedure. However, the investigators' experience has shown that the majority of lung cancer patients can comfortably hold short repeated DIBHs during treatment sessions throughout the eight weeks of their treatment course, even if they have a relatively poor lung function.
The differences in side-effects between patients treated with the INHALE regimen and a large group of patients previously treated at our institution will be thoroughly investigated, using both follow-up CT images and a range of clinical parameters. INHALE is a unique study because of combining use of the highest level of technology to ensure high-quality treatment in DIBH and a thorough scientific investigation of follow-up data. INHALE will provide an improved understanding of how to assess and decrease treatment side-effects: consequently the investigators aim to test the hypothesis in a large clinical trial in order to improve survival of lung cancer patients.
Conditions: Lung Neoplasms
Intervention / Treatment:
RADIATION: DIBH VMAT
| Inclusion Criteria:
* Histologically confirmed non-small cell lung cancer (NSCLC)
* Referral and eligibility for concomitant or sequential radiotherapy
* Performance status ≤ 2
* Signed informed consent
Exclusion Criteria:
* Failure to fulfill inclusion criteria | 29,167 |
Study Objectives
Subjects undergoing surgery on the small or large bowel will be randomized to one of 2 groups, a normal fluid amount group and a reduced fluid amount group to evaluate the impact of this change on recovery after surgery.
Conditions: Benign Neoplasm of Intestinal Tract, Primary Malignant Neoplasm of Intestinal Tract, Secondary Malignant Neoplasm of Intestinal Tract
Intervention / Treatment:
PROCEDURE: Normal fluid volume, PROCEDURE: Reduced fluid volume
| Inclusion Criteria:
* Patients 18 years or older
* ASA I-III
* Ability to provide informed consent
* Creatinine less than or equal to 1.3 mg/mL)
Exclusion Criteria:
Patients younger than 18 years old
* ASA IV or higher
* Urgent or emergent surgery
* Mental disease or addictive disorders impairing ability to provide informed consent
* Renal insufficiency (Cr greater than 1.3 mg/mL)
* Significant language barriers
* Cirrhosis causing ascites
* NYHA III or IV, EF less than 25%
* Use of intraoperative epidural anesthesia
* Uncontrolled diabetes
* Uncontrolled hypertension in the opinion of the enrolling surgeon
* ETOH consumption greater than 35 drinks weekly
* Cachexia or absolute neutrophil count of less than 1,200/mm3
* Existing uncontrolled coagulopathy or platelet count of less than 100,000/mm3 | 724 |
Study Objectives
The NeuroBlate® System (NBS), is a minimally invasive robotic laser thermotherapy tool. It employs a pulsed surgical laser to deliver targeted energy to abnormal brain tissue caused by tumors and lesions. Since receiving FDA clearance in April 2013, the NBS has been used in nearly 300 procedures conducted at approximately 20 leading institutions across the United States. This post-market, multi-center retrospective study is designed to collect long-term follow-up data on patients who were treated previously with NBS.
Conditions: Primary Brain Tumor
Intervention / Treatment:
PROCEDURE: NeuroBlate® System Therapy
| Inclusion Criteria:
* Patient was previously treated with NBS
* Patient is willing and able to provide informed consent and authorization for release of personal health information or IRB waiver is granted to collect study information without patient consent
Exclusion Criteria: There are no exclusion criteria for this study. | 10,012 |
Study Objectives
The purpose of this study is to learn whether the patient might be interested in skin cancer genetic testing, and if so, what kinds of thoughts, feelings, and behaviors might result from this testing. Testing for skin cancer risk based on the MC1R gene is not currently used in clinical practice; it will be offered in this study for research purposes only.
Conditions: Non-melanoma Skin Cancer (NMSC)
Intervention / Treatment:
GENETIC: MC1R genotyping, BEHAVIORAL: MC1R Testing Website, BEHAVIORAL: Baseline Survey
| Inclusion Criteria:
* 18 years of age or older
* English fluent as we do not have the resources to translate all the materials including the website and risk feedback materials into other languages
* Prior history of stage 0, I or II NMSC as per EMR or clinical judgment
Exclusion Criteria:
* Inability to provide meaningful informed consent due to cognitive or psychiatric disability as determined by the judgement of the consenting professional or clinician | 24,906 |
Study Objectives
It is accepted that giving higher doses of chest radiation in as short a time span as possible improves chances of cure. In this study, the investigators propose to give an increased dose of chest radiotherapy for limited stage small cell lung cancer patients using a strategy of giving a slightly higher daily dose of radiotherapy than normal. The investigators hypothesize that our proposed chest radiotherapy dose will improve 2-year overall survival rates in patients with limited stage small cell lung cancer.
Conditions: Lung Neoplasm, Small Cell Carcinoma
Intervention / Treatment:
RADIATION: Hypofractionated Chest Radiotherapy
| Inclusion Criteria:
* limited stage small cell lung cancer
* adequate pulmonary function test (FEV1 >1.0 L, DLCO >50%)
* signed study consent
* age at least 18 years
* Karnofsky performance status as least 70%
* eligible to receive standard concurrent small cell cancer chemotherapy
Exclusion Criteria:
* extensive stage disease
* mixed non small cell and small cell histology
* inadequate pulmonary function tests
* not eligible for concurrent chemotherapy
* subtotal or total tumor resection
* previous chest/neck radiotherapy
* prior or concurrent malignancy except non-melanomatous skin unless disease free for last 5 years
* pregnant
* prior chemotherapy for another malignancy
* patients with myocardial infarction within the preceding 6 months of symptomatic heart disease, including, angina, congestive heart failure, uncontrolled arrhythmias | 12,440 |
Study Objectives
A 65 year old female participant , right handed, started with progressive bilateral visual loss in her temporal field, over 10 months, the participant underwent an MRI and it was found a sellar lesion that compressed the optic chiasm, an endoscopic endonasal transsphenoidal surgery was done for the resection of the lesion, using a novel bilaminar chitosan scaffold to assist the closure of the sellar floor. After a follow up of 2 years the participant returned to its normal visual function, without evidence of the sellar lesion on the postoperative MRI, and without complications.
Conditions: Csf Leakage
Intervention / Treatment:
OTHER: Implant of bilaminar chitosan scaffold
| Inclusion Criteria:
* male/female patient candidate for an endoscopic endonasal transphenoidal surgery, who need repair of the sellar floor as part of the surgical procedure.
Exclusion Criteria:
* Diabetes, heart diseases, immunological diseases, infectious diseases, bone diseases. | 28,578 |
Study Objectives
In this prospective, open, controlled, cross-sectional observational study patients with psoriasis or IBD, who received either anti-TNF-alpha inhibitors or alternates (purine-, folic acid analogues, phototherapy, fumaric ester, mesalazine) for their underlying disease were included.
Anogenital HPV-induced lesions, mucosal HPV DNA and serological status of mucosal low-risk (HPV6) and high-risk HPV (HPV16, HPV18) were determined.
Conditions: Psoriasis, Inflammatory Bowel Diseases
Intervention / Treatment:
DRUG: TNF-alpha inhibitors, DRUG: Alternative/no medication, OTHER: Alternative/no medication, DRUG: Purine/folic acid analogues
| Inclusion Criteria:
* Participants between 18-80 years of age with a history of psoriasis or inflammatory bowel diseases, namely Crohn's disease and ulcerative colitis, and
* at least 6 month of continuous treatment regimen.
Exclusion Criteria:
* Pregnant or nursing patients and
* patients with inherited immune disorders, human immunodeficiency virus infection, invasive malignancies or psychomotor retardation and
* patients with psoriasis or inflammatory bowel diseases who had received high-dose corticosteroids during the past 6 months. | 31,715 |
Study Objectives
The purpose of this study is to evaluate the safety and immunogenicity of GSK Biologicals' vaccine GSK1437173A in subjects aged 18 years and older with blood cancers. The study will evaluate safety-related events and antibody and cellular immune responses to the study vaccine, as compared to placebo.
Conditions: Herpes Zoster
Intervention / Treatment:
BIOLOGICAL: Herpes zoster vaccine (GSK 1437173A), DRUG: Placebo
| Inclusion Criteria:
* Subjects who the investigator believes can and will comply with the requirements of the protocol.
* Written informed consent obtained from the subject.
* A male or female, aged 18 years or older at the time of study entry.
* Subject who has been diagnosed with one or more haematologic malignancies prior to the first vaccination and who is receiving, is scheduled to receive or has just finished immunosuppressive cancer therapy to treat this condition.
* Life expectancy greater than or equal to 12 months, as assessed by the investigator.
* Female subjects of non-childbearing potential may be enrolled in the study.
* Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
* Female subjects of childbearing potential may be enrolled inthe study, if the subject:
* has practiced adequate contraception for 30 days prior to vaccination, and
* has a negative pregnancy test on the day of vaccination, and
* has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
Exclusion Criteria:
* Subject diagnosed with chronic lymphocytic leukaemia (CLL) who is receiving only oral cancer therapy (subject receiving intra-venous cancer therapy for CLL or intra-venous cancer therapy in combination with oral therapy may be enrolled).
* Subject receiving radiotherapy alone as treatment for his/her haematologic malignancy.
* Planned haematopoietic stem cell transplant (HCT) during the study period. (If a HCT occurred prior to enrolment in the study, the subject may not receive study vaccine until at least 50 days after the transplant procedure).
* Human immunodeficiency virus (HIV) infection by clinical history.
* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine/placebo, or planned use during the study period. However, the investigational use of a registered product to treat the subject's underlying disease, is allowed.
* Previous vaccination against HZ or varicella within the 12 months preceding the first dose of study vaccine/placebo.
* Planned administration during the study of a HZ or varicella vaccine (including an investigational or non-registered vaccine) other than the study vaccine.
* Occurrence of a varicella or HZ episode by clinical history within the 12 months preceding the first dose of study vaccine/placebo.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
* Administration or planned administration of a live vaccine in the period starting 30 days before the first dose of study vaccine and ending 30 days after the last dose of study vaccine.
* Administration or planned administration of a non-replicating vaccine within 8 days prior to or within 14 days after either dose of study vaccine.
* Pregnant or lactating female.
* Female planning to become pregnant or planning to discontinue contraceptive precautions before Month 3 (i.e., 2 months after the last dose of study vaccine/placebo). | 4,143 |
Study Objectives
The primary purpose of this study is to help answer the following research questions:
* To assess whether Enzastaurin combined with rituximab, gemcitabine and oxaliplatin (R-GEMOX) can help participants with Diffuse Large B-Cell Lymphoma (DLBCL) remain free from disease and thus live longer.
* To assess for any side effects that might be associated with enzastaurin and R-GEMOX .
* To look at the characteristics and levels of certain genes and proteins to learn more about DLBCL and how enzastaurin works in the body.
* To look at the level of enzastaurin in the body and how long it remains.
Conditions: Lymphoma, Large Cell, Diffuse
Intervention / Treatment:
DRUG: enzastaurin, DRUG: gemcitabine, DRUG: rituximab, DRUG: oxaliplatin
| Inclusion Criteria:
* Diagnosis of DLBCL or transformed (cluster differentiation 20 \[CD20\]+) indolent lymphoma
* Relapsed/progressed after response obtained in 1st- or 2nd-line treatment, or participants who have not progressed after stable disease (SD) obtained in 1st- or 2nd-line.
* Measurable disease (lymph node greater than 1.5 cm)
* Adequate organ function
* Greater than or equal to 60 years or less than 60 (but greater than or equal to 18 years) who are not eligible for high-dose chemotherapy high-dose chemotherapy (HDC) and autologous stem cell transplant (ASCT)
Exclusion Criteria:
* Prior Allogeneic transplantation
* More than 2 prior anticancer treatment regimens
* Pregnant or breastfeeding
* Human-immunodeficiency-virus (HIV)associated lymphomas
* Brain metastases | 19,294 |
Study Objectives
The study consists of a retrospective observational, multicenter study in which the fundamental exposure factor being investigated is a drug (rucaparib).
A clinical database will be built including clinical data in three scenarios of rucaparib treatment: (1) platinum-sensitive BRCA-mutated patients after progression, (2) maintenance therapy in patients after a platinum-sensitive relapse in response, and (3) treatment therapy in BRCA-mutated patients who are currently platinum-resistant.
The specific objectives of the study are:
* To describe patient characteristics/medical history, safety, efficacy, and dosing of on-label treatment with rucaparib in real-world patients (real-world data).
* To describe patient characteristics/medical history, safety, efficacy, and dosing of all patients treated with rucaparib (including patients with on-label treatment and others) in real-world patients (real-world data).
* To show that data obtained in clinical trials could be reproduced in non-screened patients.
Conditions: Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
Intervention / Treatment:
DRUG: Rucaparib
| Inclusion Criteria:
* Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccessible patients (dead, lost, etc.) according to ethics committee permissions and applicable law for retrospective studies in Spain.* Histological diagnosis of high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.* Adult women (18 years or more at the time of diagnosis).
Exclusion Criteria:
* Patients without medical record available (lost, empty or unretrievable clinical information). | 18,494 |
Study Objectives
Flax seed oil, fish oil, and soy bean oil, are commonly recommended supplements for Polycystic Ovarian Syndrome (PCOS). These oils have different chemical structures and biological actions. It is not yet known which of these oils has the most beneficial effects in PCOS patients because they have never been compared to each other head to head. In this study the researchers hope to learn more about the effects of these oils on blood sugar and insulin levels.
Conditions: Polycystic Ovarian Syndrome
Intervention / Treatment:
DIETARY_SUPPLEMENT: Flax Seed Oil, DIETARY_SUPPLEMENT: Fish Oil, DIETARY_SUPPLEMENT: Soybean Oil
| Inclusion Criteria:
* Females ages 18-45
* Women who are overweight, and have irregular periods or have been diagnosed with Polycystic Ovarian Syndrome
Exclusion Criteria:
* Use of oral contraceptives
* Impaired glucose tolerance
* Diabetes mellitus, and any other systemic illnesses such as renal, hepatic, gastrointestinal, severe hyperlipidemia and hypertension that require medication
* Schizophrenia
* Having a pacemaker
* Current viral infection
* Smoking alcohol intake (more than 2 drinks/week) | 3,184 |
Study Objectives
In this study, the investigators have compared the clinical outcomes of the laparoscopic and open right hemicolectomy within enhanced recovery after surgery (ERAS) programs in the treatment of right-sided colon cancer.
Conditions: Colon Cancer
Intervention / Treatment:
PROCEDURE: Laparoscopic right hemicolectomy plus ERAS, PROCEDURE: Open right hemicolectomy plus ERAS
| Inclusion Criteria:
* Age ≥ 18 and ≤ 75 years;* Primary tumor has undergone histologically confirmed right-sided colon adenocarcinoma;* Together with clinical or radiological evidence of Stage(T1-2,N0, M0) Stage II (T3-4, N0, M0) or Stage III (T1-4, N1-2, M0) disease (according to the 2007 revision of the International Union Against Cancer TNM staging system)* Performance status (ECOG) 0\~1* Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; Hb ≥9g/dl (within 1 week prior to randomization)* Adequate hepatic and renal function: Serum bilirubin≤1.5 x upper limit of normal (ULN), alkaline phosphatase ≤5x ULN, and serum transaminase (either AST or ALT) ≤ 5 x ULN(within 1 week prior to randomization);* Written informed consent for participation in the trial.
Exclusion Criteria:
* Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix* Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding* Known drug abuse/ alcohol abuse* Legal incapacity or limited legal capacity* Pre-existing peripheral neuropathy. | 30,242 |
Study Objectives
The main purpose of the study is to evaluate a safe, tolerable recommended Phase II dose (RP2D) and/or the maximum tolerated dose (MTD) of M3814 when given in combination with avelumab with and without radiotherapy in participants with selected advanced solid tumors.
Conditions: Oncology, Solid Tumors
Intervention / Treatment:
DRUG: M3814, DRUG: M3814, DRUG: Avelumab, RADIATION: Radiotherapy
| Inclusion Criteria:
* Part A and Part FE (M3814 + avelumab): Participants must have histologically or cytologically proven advanced or metastatic solid tumors for which no standard therapy exists, standard therapy has failed, or participants are intolerant to or have rejected established therapy known to provide clinical benefit for their condition
* Part B (M3814 + Radiotherapy \[RT\] + avelumab): histologically or cytologically proven advanced or metastatic solid tumors for which no standard therapy exists, standard therapy has failed, or participants are intolerant to or have rejected established therapy known to provide benefit for their condition and are amenable to receive RT
* Part A, B and FE: Measurable or evaluable disease according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1)
* Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1 at study entry
* Part A, B and FE: Female participants of childbearing potential should be willing to use a highly effective contraceptive method
* Part A, B and FE: Male participants should agree to refrain from donating sperm plus, either: abstain from any activity that allows for exposure to ejaculate
* Use an adequate method of contraception starting with the first dose of study therapy through 90 days after the last dose of study therapy
* Part A, B and FE: Be willing to provide informed consent for the trial
* Other protocol defined inclusion criteria could apply
Exclusion Criteria:
* Participants who have received prior chemotherapy, hormonal anticancer therapy with the exception of luteinizing hormone-releasing hormone analogs, biologic therapy, or any other anticancer therapy within 28 days of the first dose of study treatments (6 weeks for nitrosoureas or mitomycin C)
* Participants who have undergone major surgery for any reason, except diagnostic biopsy, within 4 weeks of the study intervention and/or has not fully recovered from the surgery within 4 weeks of the study intervention
* Participants with evidence of active or history of autoimmune disease that might deteriorate when receiving an immune-stimulatory agent
* Participants with brain metastases, except those meeting the following criteria: a) brain metastases that have been treated locally and are clinically stable for greater than or equal to (>=) 4 weeks prior to randomization b) no ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable) c) participants must be either off steroids or on a stable or decreasing dose of less than (<) 10 milligrams (mg) daily prednisone (or equivalent)
* Participants with severe acute or chronic medical conditions including immune colitis, inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year), psychiatric or substance abuse disorders; or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study intervention administration or may interfere with the interpretation of study results
* Participants requiring systemic immunosuppressive agents (such as steroids) for any reason who cannot be tapered off these drugs before start of study intervention, with the following exceptions: a) participants with adrenal insufficiency, may continue corticosteroids at physiologic replacement dose, equivalent to less than or equal to (<=) 10 mg prednisone daily b) participants requiring steroids through a route known to result in a minimal systemic exposure (topical, intranasal, intra-ocular, or inhalation) is permitted c) participants with previous or ongoing administration of systemic steroids for the management of an acute allergic phenomenon planned to be completed in 14 days, or that the dose after 14 days will be equivalent to <= 10 mg prednisone daily
* Participants with a history of human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome, Hepatitis B virus or Hepatitis C and with history of infection must have a polymerase chain reaction (PCR) documentation that infection is cleared
* Participants who have received a live vaccine within 30 days prior to the first dose of trial treatment
* Participants with known prior severe hypersensitivity to any of the investigational products or any component in its formulations
* Participants with evidence of additional malignancy within the last 5 years unless a complete remission without further recurrence was achieved at least 2 years prior to study entry and participants were deemed to have been cured with no additional therapy required or anticipated to be required. Participants with treated nonmelanoma skin cancers, carcinoma in situ of skin, bladder, cervix, colon/rectum, breast, or prostate may participate
* Participants pretreated with immunotherapy who have, any history of dose limiting toxicities (DLTs) with prior immunotherapy agents, including Grade 3/4 immune-related adverse events (irAEs); irreversible irAEs; Grade greater than or equals to (>=) 3 irAEs that did not respond to steroid rescue; or neurologic irAE with significant clinical sequelae
* Participants with irAE requiring hormone replacement therapy (e.g., thyroxine, insulin, or physiologic dose of corticosteroid replacement therapy for adrenal or pituitary insufficiency) may participate as long as the endocrinopathy is well controlled and the participant is not otherwise symptomatic from hormone insufficiency
* Physiologic corticosteroid dose is defined as <= 10 mg daily of prednisone or equivalent
* for Part B only:
* Participants who have confirmed esophagitis and in whom radiation planning target volume will include any portion of the esophagus, the participant is not eligible unless an esophageal endoscopy rules out the presence of esophagitis
* Participants in whom more than 10 percent (%) of the total esophagus volume might receive more than 15 gray (Gy) (50% of the prescribed radiotherapy \[RT\] dose)
* Participants who have had previous radiotherapy to the same region as intended to be irradiated in this study within the past 12 months
* Participants who have had extensive previous radiotherapy on >= 30% of bone marrow reserve or prior bone marrow/stem cell transplantation within 5 years before study start
* If participant hepatic metastatic lesion is selected to be irradiated: - the non-tumor liver volume < 700 milli liters (mL); - Child-Pugh score >= 8
* Other protocol defined exclusion criteria could apply | 7,293 |
Study Objectives
This study is designed to test the efficacy and safety of total neoadjuvant induction and consolidation CapeOX plus neoadjuvant intensity modulated radiotherapy with concurrent capecitabine for MRI defined high-risk rectal cancer.
Conditions: Rectal Cancer
Intervention / Treatment:
DRUG: Oxaliplatin, DRUG: Capecitabine, RADIATION: Intensity modulated radiotherapy, PROCEDURE: Total mesorectal excision
| Inclusion Criteria:
* Age ≥ 18 years and ≤75 years.
* ECOG Performance status 0-1.
* Histologically confirmed diagnosis of adenocarcinoma of the rectum.
* The distance from down verge of tumor to anal-rectal junction (ARJ) ≤8cm based on MRI, or ≤12 cm based on sigmoidoscopy.
* Clinical Stage T3c, T3d, T4a or T4b, or EMVI (+) or mrN2 or CRM (+) based on MRI.
* No evidence of distant metastases.
* No prior pelvic radiation therapy.
* No prior chemotherapy or surgery for rectal cancer.
* No active infections requiring systemic antibiotic treatment.
* ANC > 1.5 cells/mm3, HGB > 10.0 g/dL, PLT > 100,000/mm3, total bilirubin ≤ 1.5 x ULN, AST≤ 3 x ULN, ALT ≤ 3 x ULN.
* Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study.
Exclusion Criteria:
* Recurrent rectal cancer.
* Anticipated unresectable tumor after neoadjuvant treatment.
* Creatinine level greater than 1.5 times the upper limit of normal.
* Patients who have received prior pelvic radiotherapy.
* Patients who are unable to undergo an MRI.
* Patients with a history of a prior malignancy within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer.
* Patients with a history of any arterial thrombotic event within the past 6 months. This includes angina (stable or unstable), MI, TIA, or CVA.
* Other Anticancer or Experimental Therapy.
* Women who are pregnant or breast-feeding.
* Patients with any other concurrent medical or psychiatric condition or disease which would make them inappropriate candidates for entry into this study. | 27,838 |
Study Objectives
This clinical trial seeks to determine if avelumab will be effective in facilitating removal of all gross tumor in the event of a relapse of osteosarcoma in pediatric patients. Avelumab will be evaluated using dosing that has previously been determined in adult studies.
Primary Objectives:
* To estimate the response rate to 4 cycles of avelumab in patients with recurrent or progressive osteosarcoma.
* To estimate the 16-week progression free survival of patients with recurrent or progressive osteosarcoma after treatment with avelumab.
Secondary Objective:
* To describe the toxicities associated with the administration of avelumab in patients with recurrent or progressive osteosarcoma.
* To assess the quality of life of patients with recurrent or progressive osteosarcoma undergoing treatment with avelumab, and to explore relationships between clinical factors and patient-reported health-related quality of life (HRQOL) outcomes.
Exploratory Objectives:
* To explore factors associated with response in patients treated with avelumab after recurrent or progressive osteosarcoma (e.g. tumor PD-L1 expression).
* To measure parameters of immune activation including subsets of peripheral blood mononuclear cells (PBMCs) and serum markers of immune activation.
* To evaluate the role of T-cells in immune checkpoint blockade via measures of cell proliferation, co-inhibitory receptor expression on CD8 T cells, T cell repertoire, and epigenetic programming.
Conditions: Osteosarcoma
Intervention / Treatment:
DRUG: Avelumab, OTHER: Questionnaires
| Inclusion Criteria:
* Patients must be > 12 years of age but < 50 years of age at the time of enrollment.
* Patients must have histologic verification of osteosarcoma at initial diagnosis or relapse.
* Patients must have had evidence of having relapsed, progressed or become refractory to conventional therapy.
* Patients must have measurable disease, documented by clinical, radiographic or histologic criteria. Disease must be bi-dimensionally measurable by computed tomography (CT) or magnetic resonance imaging (MRI).
* Patients must have a performance status of ≥ 50 using the Karnofsky scale for patients > 16 years of age and the Lansky scale for patients ≤ 16 years of age.
* Patients must have a life expectancy of ≥ 6 weeks.
* Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
1. Myelosuppressive chemotherapy: must not have received within 3 weeks of entry onto this study.
2. Biologic (anti-neoplastic agent): at least 7 days since the completion of therapy with a biologic agent.
3. Immunotherapies: at least 42 days must have elapsed since a prior therapy that included a monoclonal antibody or any other type of immunotherapy (e.g. chimeric antigen receptor (CAR) T cell therapy).
4. Radiation therapy (RT): ≥ 2 weeks for local palliative RT (small port); ≥ 6 months must have elapsed if prior craniospinal RT or if ≥ 50% radiation of the pelvis; ≥ 6 weeks must have elapsed if other substantial bone marrow (BM) radiation.
* Organ Function Requirements:
1. Adequate bone marrow function defined as:
* Peripheral absolute neutrophil count (ANC) ≥ 1500/mm3
* Platelet count ≥ 100,000/mm3 (transfusion independent)
* Hemoglobin ≥ 9.0 g/dL (may receive RBC transfusions)
2. Adequate renal function defined as:
* Creatinine clearance or radioisotope GFR ≥70 mL/min/1.73m2 OR
* Serum creatinine based on age/gender as follows: (threshold creatinine values were derived from the Schwartz formula for estimating GFR).
* Age is: 12 to <13 years, then maximum creatinine is 1.2 mg/DL for male and female.
* Age is: 13 to <16 years, then maximum creatinine is 1.5 mg/DL for male and 1.4 mg/DL for female.
* Age is: ≥16 years, then maximum creatinine is 1.7 mg/DL for male and 1.4 mg/DL for female.
3. Adequate liver function defined as:
* Total Bilirubin ≤ 1.5x the institutional upper limit of normal (IULN) for age
* ALT (SGPT) and AST (SGOT) < 2.5 x IULN for age (or < 5 x IULN for patients with documented metastatic disease to the liver)
* Serum albumin > 2 g/dL
4. Serum lipase ≤ upper limit of normal (IULN).
5. Patients must have documented pulse oximetry ≥ 92% on room air.
* Female patients of childbearing potential must have a negative serum or urine pregnancy test within 7 days of enrollment.
* Male or female patients who are sexually active and of reproductive potential must agree to use an effective contraceptive method throughout the study and for at least 60 days after last avelumab treatment administration. Abstinence is an acceptable form of contraception.
* Patients must not currently be using other investigational agents.
* Patients must not currently be using other anti-cancer agent.
* Patients must be able to comply with the safety monitoring of the study in the opinion of the investigator.
* Written, informed consent and assent following Institutional Review Board, NCI, FDA and OHRP guidelines.
Exclusion Criteria:
* Central nervous system (CNS) metastases.
* Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
* Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.
* Active infection requiring systemic therapy.
* Known history of testing positive for HIV or known acquired immunodeficiency syndrome.
* Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive).
* Patient who has received vaccination within 4 weeks of the first dose of avelumab and while on trials is prohibited except for administration of inactivated vaccines.
* Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v4.03 Grade ≥ 3).
* Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II, see Appendix II), or serious cardiac arrhythmia requiring medication.
* Persisting toxicity related to prior therapy (NCI CTCAE v. 4.03 Grade > 1); however, alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable
* Other severe acute or chronic medical conditions including colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
* Patients with active diarrhea > CTCAE v4.03 Grade 2.
* Patients who have previously received a prior organ transplantation, including allogeneic stem cell transplantation.
* Female patients who are pregnant or actively breastfeeding.
* Patients who have previously received anti-PD1 or anti-PD-L1 therapy. Patients who have previously received anti-CTLA-4 therapy (e.g. ipilimumab) are eligible for study. | 16,031 |
Study Objectives
The primary objective of this study is to estimate the frequency of FGFR2 fusions in archived intrahepatic cholangiocarcinoma (iCCA) or mixed hepatocellular-cholangiocarcinoma (HCC-CCA) tumor samples
Conditions: Intrahepatic Cholangiocarcinoma, Mixed Hepatocellular Cholangiocarcinoma, Cholangiocarcinoma
Intervention / Treatment:
| Inclusion Criteria:
* If required by law or local regulations (i.e., the sample is from an identifiable subject), signed written informed consent should be granted prior to use of the sample in the study
* ≥ 18 years of age
* Histologically or cytologically confirmed iCCA or mixed HCC-CCA, who are/were eligible for systemic therapy (samples collected prior to initiation of the systemic therapy may be submitted for testing)
* Have one or more formalin fixed and paraffin embedded blocks available. If blocks are not evaluable, 7-10 unstained, non-baked slides with 5-micron thick sections with at least 20% tumor tissue should be available. (Potential participants who are scheduled to undergo surgical treatment may agree to provide surplus of tissues not required for diagnosis and have to provide informed consent prior to the surgery.)
Exclusion Criteria:
* Not applicable: Patients must meet all of the inclusion criteria. | 9,128 |
Study Objectives
The kind of equipment used during laparoscopic surgery may have an effect on how quickly resident surgeons improve their skills.
The effects of these technologies on various general and specialized procedures have been the subject of numerous research, all of which have produced comparable results in terms of efficacy and safety. Although a minimally invasive laparoscopy represents the gold standard method in over 70% of procedures for uterine and adnexal benign diseases, there is a paucity of evidence regarding the potential advantages or disadvantages of such kinds of devices in gynecologic laparoscopy.
Based on this, the purpose of this study was to determine whether using a hemostatic surgical device affects how quickly gynecology residents learn to execute simple laparoscopic procedures and how well they perform surgically.
Conditions: Benign Gynecologic Neoplasm
Intervention / Treatment:
PROCEDURE: Laparoscopy
| Inclusion Criteria:
* Senior gynecological surgeons
* At least 4 years of residency in gynecology
Exclusion Criteria:
* Junior residents, fellows, consultants
* Operative procedures due to malignancy
* Women who were not suitable for or denied a laparoscopic approach
* Declined the procedure
* Did not sign a written informed consent form
* Suffering from a gynecologic malignant disease or severe systemic illnesses
* Laparotomic conversion | 5,152 |
Study Objectives
This cohort study will obtain electronic health record (EHR) data (limited data set) from 21 health systems affiliated with the Cancer Center Cessation Initiative (C3I) network or health systems with large numbers of COVID-19 patients to explore whether smoking status, cancer history, and other risk factors among patients diagnosed with COVID-19 are associated with mortality and/or COVID-19 disease severity/complications. Each site will provide data from their health system EHR on a regular basis that includes all patients identified as having COVID-19 at some point in the interval from February 1, 2020, through January 31, 2022.
Conditions: COVID-19, Cancer, Nicotine Dependence, Pulmonary Disease, Cardiovascular Diseases, Immunosuppression Disorders
Intervention / Treatment:
| Inclusion Criteria:
* COVID-19 ICD-10-CM diagnosis (U07.1 or J12.82) during a healthcare visit and/or
* COVID-19 positive PCR test and/or
* COVID-19 positive antigen test
Exclusion Criteria:
* N/A | 35,173 |
Study Objectives
Up to 24 patients with stage III or stage IV melanoma will be enrolled. Patients who are currently disease-free but at high risk for relapse are also eligible. Patients will receive vaccinations of gp75 at assigned dose levels. Patients who exhibit serologic and stable/clinical response are eligible to receive booster vaccinations. Patients will be evaluated for safety and efficacy throughout the duration of the study. In this study, the optimal biologically effective dose is defined as the lowest dose of gp75 that results in the production of anti-gp75 antibodies.
Conditions: Malignant Melanoma
Intervention / Treatment:
BIOLOGICAL: gp75 DNA vaccine
| Inclusion Criteria:
* The patient has a diagnosis of American Joint Commission on Cancer (AJCC) stage 111 or IV malignant melanoma. A patient who is free of disease after surgical resection of stage 111 or IV disease, but at high risk (defined as a primary tumor >4 rnm, satellite or in-transit lesions, one or more positive lymph nodes or distant metastases) for recurrence is also eligible. A patient with metastatic disease may have no more than five sites of disease. The skin represents one site regardless of the number of lesions. Stage 111 melanoma is defined as a pT4 primary tumor (>4m in depth or Clark level 5) in-transit metastases, satellites lesions or regional lymph nodes involved with melanoma.Pathology slides must be reviewed by the investigational site's Department of Pathology.* The patient's Karnofsky performance status is 280 at study entry.* The patient has given signed informed consent.* The patient has had surgery for their melanoma at least 6 months prior to study entry, or has had prior interferon therapy, or developed unacceptable toxicities to interferon therapy, or has a pre-existing condition(s) that precludes the patient fkom receiving interferon treatment.* The patient is 21 8 years of age.* The patient must have completed any prior irradiation, chemotherapy, or systemic immunotherapy (interferon-alpha, or interleukin-2) at least 30 days prior to study entry.* The patient has adequate hematologic function as defined as a platelet count 2100,000/mm3 and white blood cell (WBC) level 23,000/mm3.* The patient has serum lactose dehydrogenase (LDH) within normal range and a serum creatinine level <2.0 mg/dL.* The patient agrees to use effective contraception if procreative potential exists.
Exclusion Criteria:
* The patient has stage I11 disease otherwise eligible to receive standard of care melanoma therapy.* The patient has a medical condition or use of medication (eg, corticosteroids) that might make it difficult for the patient to complete the full course of treatments or to respond immunologically to them, in the opinion of the investigator.* The patient has received irradiation, chemotherapy, or systemic immunotherapy (interferon-alpha, or interleukin-2) within 30 days prior to study entry.* The patient is pregnant (confirmed by serum beta human chorionic gonadotropin \[PHCG\], if applicable) or is breast feeding.* The patient has received any investigational agents within 30 days of study entry.* The patient has received prior cancer vaccine therapy.* The patient has evidence of central nervous system (CNS) metastasis.* The patient has evidence of an ocular abnormality, as detected by a slit-lamp ophthalmologic examination, within 4 weeks prior to study entry. | 30,580 |
Study Objectives
Major weight loss and taste changes are well documented in patients with hematological cancer during chemotherapy. It has previously been documented, that such patients have preferences for much umami, a little sweet, sour and salt, and no bitter. The purpose of the study was to convert these results into real diets. Patients participated in two sensory pilot studies (n=10), where dishes were tested for preferences before and after chemotherapy. From these results four dishes were selected and tested on 32 patients in 30 days in a cross-over design. The diets resulted in a beneficial and statistical significant difference in weight development (p= 0.0008), with 1.2 ± 1.9 kg (+2%) in the intervention period and -2.8 ± 5.2 kg (-4%) in the control period. This difference persisted after sensitivity analysis (± 10%) p= 0.005. However, the nutritional intake was still low in both periods, and the treatment with cytarabin turned out to be a major confounder as dosage was significantly higher in the control period.
Conditions: Hematological Malignancy
Intervention / Treatment:
DIETARY_SUPPLEMENT: Special diet
| Inclusion Criteria:
* Hematological cancer
* Ongoing chemotherapy
* Ability to eat by mouth
* Informed consent
Exclusion Criteria:
* Lack of the ability to understand the informations given
* Lack of the ability to understand the conditions of the experiment | 34,609 |
Study Objectives
Rivaroxaban has been developed in the various clinical settings, prevention of venous thromboembolism (VTE)after major orthopedic surgery, prevention of stroke in atrial fibrillation, and in the treatment of acute coronary syndromes. And, in the EINSTEIN-pulmonary embolism (PE) and EINSTEIN-deep venous thrombosis (DVT) programs, rivaroxaban showed non-inferior to standard therapy for the treatment of PE and DVT. However, there has been limited experience of rivaroxaban with secondary VTE prophylaxis in cancer patients. Although cancer-associated DVT or PE was included in previously mentioned EINSTEIN programs, only approximately 5% of the total populations were cancer patients in these studies. Thus, investigators could not automatically translate the results of these studies into the real practice management of cancer-associated VTE patients. Moreover, until now, new oral anticoagulants, including dabigatran and rivaroxaban, have been compared to long-term warfarin therapy, which were well-known inferior agent, but not low molecular weight heparin. In this sense, investigators feel that new oral anticoagulants, particularly rivaroxaban, should be re-investigated in this highly specific patients group. Therefore, investigators are planning to conduct a prospective study evaluating the efficacy and safety of rivaroxaban in Korean patients with cancer-associated VTE.
Conditions: Rivaroxaban, Cancer-associated Thrombosis, Recurrence, Bleeding
Intervention / Treatment:
DRUG: Rivaroxaban
| Inclusion Criteria:
* Patients ≥ 20 years old and active cancer and newly-diagnosed, symptomatic or incidental proximal lower extremity DVT, PE or both
* will have a life expectancy > 3 months
* will be treated with anticoagulation therapy for at least 3 months.
Exclusion Criteria:
* (1) Isolated asymptomatic distal DVT
* (2) Intra-abdominal venous thrombosis or vascular access-induced thrombosis
* (3) Hemodynamically unstable PE, indicating systolic blood pressure <90 mmHg
* (4)Eastern Cooperative Oncology Group (ECOG) performance status score of 3 or 4
* (5) History of total gastrectomy
* (6) Overt brain metastasis. Patients who have controlled brain metastasis without need of glucocorticoid are eligible
* (7) History of recent major or clinically relevant bleeding within the previous 4 weeks
* (8) Conditions associated with a high risk of serious bleeding (active peptic ulcer or recent neurosurgery)
* (9) Other serious illness or medical conditions (illnesses requiring chronic anticoagulation therapy, unstable cardiac disease despite treatment, myocardial infarction within 3 months prior to study entry, significant neurologic or psychiatric diseases including dementia or seizure, active uncontrolled infection, other serious medical conditions)
* (10)Inadequate renal function; creatinine clearance < 30 ml/min
* (11) Inadequate hepatic function: alanine aminotransferase > 3 times the upper limit of normal (ULN) (if liver metastasis, alanine aminotransferase > 5 times the ULN or total bilirubin >2 times the ULN (if liver metastasis, total bilirubin >3 times the ULN)
* (12) Baseline platelet count < 75,000 per cubic millimeter or Hb < 8g/dL
* (13) Plan of treatment with bevacizumab or other anti-cancer drugs known to increase the bleeding risk
* (14) Women of childbearing potential who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for the entire study period, who are using a prohibited contraceptive method, or who are pregnant or breastfeeding
* (15) Patients requiring strong cytochrome P450 3A4 (CYP3A4) inducers (rifampin, phenobarbital) or strong CYP3A4 inhibitors (HIV protease inhibitor, systemic ketoconazole) treatments
* (16) Patients with inferior vena cava filter placement or underwent catheter-directed thrombolysis or stent placement for the treatment of index VTE | 37,422 |
Study Objectives
This is a two-arm, randomized Phase II study of intermittent chemotherapy with and without GM-CSF. All patients will receive six 21-day cycles of docetaxel 75 mg/m2 on Day 2 of each cycle and 5 mg prednisone twice a day on Days 1-21. Following six cycles of chemotherapy, eligible subjects will be randomized to no maintenance therapy or to maintenance GM-CSF therapy. The GM-CSF group dose schedule will be 250 mcg/m2 subcutaneous (SQ) daily Days 15-28 every 28 days. Patients in both groups will continue until disease progression at which time GM-CSF will be discontinued and chemotherapy will again be administered.
Conditions: Prostate Cancer
Intervention / Treatment:
DRUG: Docetaxel, DRUG: Docetaxel and GM-CSF
| Inclusion Criteria:
* Age over 18 years* Histologically documented adenocarcinoma of the prostate* Progressive metastatic prostate cancer* Castrate levels of testosterone (<50 ng/ml) must be maintained* Prior hormonal therapy or medications :
Patients who are receiving an anti-androgen, secondary hormonal therapy (i.e. ketoconazole, aminoglutethimide, megestrol acetate, diethylstilbestrol), 5-alpha reductase inhibitor (i.e. finasteride (Proscar), dutasteride (Avodart)) or herbal prostate medication (i.e. saw palmetto, PC-SPES, PC-PLUS) must discontinue the drug by the date of initiation of chemotherapy on study* ≥ 4 weeks since major surgery and fully recovered* ≥ 4 weeks since any prior radiation with any toxicity attributable to radiation resolved to ≤grade 1* ≥ 8 weeks since the last dose of strontium or samarium* Sexually active patients must agree to use adequate contraception* Karnofsky Performance Status ≥ 60%* Life expectancy >12 weeks* Required initial laboratory values Absolute neutrophil count > 1500/ul Platelets > 100,000/ul Hemoglobin > 8.0 g/dl Creatinine ≤ 2.0 X upper limit of normal Bilirubin ≤upper limit of normal (ULN)
aspartate aminotransferase (AST) / alanine aminotransferase (ALT) / alkaline phosphatase: AST AND ALT AND alkaline phosphatase must be within the range allowing for eligibility In determining eligibility, the more abnormal of the 2 values (AST or ALT should be used. An abnormal alkaline phosphatase must be attributed to liver dysfunction and not metastatic bone involvement (i.e elevated gamma-glutamyl transpeptidase (GGTP) or evidence of liver metastases)
Inclusion criteria for late enrolling patients:
* Age over 18 years* Histologically documented adenocarcinoma of the prostate* ≤3 cycles of prior docetaxel chemotherapy for metastatic disease permitted prior to enrollment* Docetaxel must have been administered on an every 3 week schedule* Each docetaxel dose must have been between 60 and 75 mg/m2* Castrate levels of testosterone <50 ng/mL* Daily use of other steroids (hydrocortisone, dexamethasone) instead of prednisone or no steroids, is permitted up until time of enrollment* A Prostate-specific antigen (PSA) level must have been documented within 6 weeks of initiating docetaxel chemotherapy
Exclusion Criteria:
* Prior systemic chemotherapy for prostate cancer, other than q 3-week docetaxel/prednisone. Prior neoadjuvant or adjuvant chemotherapy is permitted if there was no evidence of disease relapse within 12 months of the last dose of chemotherapy.* >3 cycles of q3 week docetaxel/prednisone chemotherapy has already been administered to the patient* Peripheral neuropathy >grade 1* Prior immunotherapy including systemic GM-CSF or vaccines utilizing GM-CSF; prior G-CSF support of chemotherapy-related neutropenia is permitted* Prior biologic agents (i.e.,anti-angiogenic agents, anti-Epithelial Growth Factor Receptor (EGFR) inhibitors)≤ 4 weeks prior to registration* More than two prior therapies with an investigational agent, completed ≤ 4 weeks prior to enrollment (no prior immunotherapeutics are allowed)* Myocardial infarction or significant change in anginal pattern within the last 6 months, symptomatic congestive heart failure (NYHA Class III or higher) or uncontrolled cardiac arrhythmia* Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded* Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 will be excluded* Poorly controlled diabetes (fasting blood glucose >250) despite optimization of medical therapy
Exclusion criteria for late enrolling patients:
* Prior immunotherapy including systemic GM-CSF or vaccines utilizing GM-CSF; prior G-CSF support for chemotherapy-related neutropenia is permitted* Delay of ≥6 weeks between any 2 chemotherapy cycles prior to enrollment on study* Cumulative delays ≥8 weeks between chemotherapy cycles prior to enrollment on study | 17,239 |
Study Objectives
Cancer is a worldwide spread disease with high prevalence and incidence, often of poor prognosis because it is typically diagnosed in an advanced stage. Another reason for this prognosis is the presence of malnutrition, on the one hand because of a diminished intake (due to anorexia), and on the other hand because of tumor-induced hypercatabolism. The result is a pathological state of the body called "cachexia", generally defined as a weight loss \> 5% during the last 6 months before diagnosis. It had already been demonstrated that correct nutrition in such patients can limit morbidity, while promoting progression-free survival as well as well-being. The pilot study, previously performed by the investigators, was the first to suggest that Nutrition Therapy, based on the ESPEN guidelines and resting energy expenditure measured by indirect calorimetry, can promote overall survival. The aim of this project is to validate these preliminary results in a larger RCT (randomized controlled double-blind trial), to promote Nutrition Therapy as a novel modality in its own right in the treatment of cancer, rather than being merely supportive.
Conditions: Metabolism and Nutrition Disorder
Intervention / Treatment:
DIETARY_SUPPLEMENT: Nutrition Therapy, DIETARY_SUPPLEMENT: Control Therapy
| Inclusion Criteria:
* > 18 years
* Male and female
* Colorectal, lung, oesofageal, gastric, pancreatic or head and neck cancer before chemo- or radiotherapy is started (naive to treatment), but surgery may already have been performed OR relapse > 3 months after initial oncologic therapy
* Oncologic cachexia (undesired weight loss > 5% in less than 6 months), before or during treatment
* Written informed consent / ability to give informed consent
Exclusion Criteria:
* concomitant second malignancy
* uncertainty of diagnosis
* patient unfit for chemotherapy, radiotherapy or surgery
* palliative treatment or terminal patient (life expectancy < 3 months)
* patient already participating in another study
* Pregnancy / lactation
* Any other pathology present that causes the patient to be unfit for oncologic therapy (e.g. end-stage renal failure, severe COLD, severe heart failure)
* Unable to adhere to protocol instructions (e.g. language barrier)
* Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study | 36,614 |
Study Objectives
The safety, tolerability, efficacy and pharmacokinetics of ASA404 when administered in combination with paclitaxel and Carboplatin are assessed. ASA404 is administered intravenously every 21 days to Japanese patients with Non small cell lung cancer.
Conditions: Non-small Cell Lung Cancer
Intervention / Treatment:
DRUG: ASA404
| Inclusion criteria:
* Histologically or cytologically confirmed non-small cell carcinoma of the lung.* Newly diagnosed Stage IIIb disease or Stage IV disease* No prior treatment for Stage IIIb/IV non-small cell carcinoma of the lung (Note: Prior neoadjuvant or adjuvant chemotherapy within 6 months is allowed.)* Age ≥ 20 years old* WHO Performance status of 0-1* Lab values within the range as defined below within 2 weeks of study registration (Note: without the use of growth factors or blood transfusions):
* Absolute neutrophil count (ANC) > 2.0 x 109/L
* Platelets ≥ 100 x109/L
* Hemoglobin ≥ 9.5 g/dL
* Serum creatinine ≤ 1.5 x ULN or 1.5 mg/dL
* Serum bilirubin ≤ 1.5 x ULN
* Aspartate transaminase (AST) and alanine transaminase (ALT)
≤ 2.5 x ULN
* PT-INR ≤ 1.5 x ULN
* Potassium ≥ LLN or correctable with supplements.
* Total calcium (corrected for serum albumin) ≥ LLN or correctable with supplements.
* Magnesium ≥ LLN or correctable with supplements.
* Females of child-bearing potential must have negative pregnancy test (serum)* Life expectancy ≥ 12 weeks* Written informed consent obtained according to local guidelines
Exclusion criteria:
* Patients having symptomatic CNS metastases and requiring treatment* Patients with second primary cancer, with the exception of non-melanoma skin cancer or cervical cancer in situ.* Radiotherapy ≤ 4 weeks prior to registration (In case of palliative radiotherapy 2 weeks prior to registration* Major surgery ≤ 4 weeks prior to registration (major surgery is defined by the use of general anesthesia). Minor surgery ≤ 2 weeks prior to registration. Insertion of a vascular access device is allowed. Patients must have recovered from all surgery-related complications.* Concurrent use of other investigational agents and patients who have received investigational agents ≤ 4 weeks prior to registration* Prior exposure to VDAs or other vascular targeting agents (anti-VEGF, anti-VEGF receptor agents, anti-EGFR agents* Patients with pleural effusion to be drained (Patients who have recurrence of pleural effusion and/or it takes 2 weeks before registration after drainage are allowed)* Patients with recent hemoptysis associated with NSCLC (>1 teaspoon in a single episode within 4 weeks)* Known allergy or hypersensitivity to platinum-containing drugs, taxanes, other drugs formulated in Cremophor EL (polyoxyethylated castor oil) or any known excipients of these drugs.* Peripheral sensory neuropathy with functional impairment (CTC Grade 2 neuropathy, regardless of causality)* ≥ CTC Grade 2 cardiac arrhythmias (i.e. symptomatic, but may not require medications).* Pregnant or breast feeding females* Patients who take medicine that are known to prolong the QT interval* Women of child bearing potential or sexually active males, unwilling or unable to use the required highly effective method(s) of contraception for both sexes while receiving treatment and for at least 6 months after the discontinuation of study treatment. (Adequate forms of contraception include IUD, oral or depot contraceptive or the barrier method plus spermicide.)* Patients with any one of the following
* Patients with Long QT Syndrome
* Patients with a Baseline 12-lead ECG QTc of > 450 msec in males or > 470 msec in females.
* Congestive heart failure(NY Heart Association class III or IV)
* Patients with a myocardial infarction within 12 months of study entry
* Unstable or poorly controlled angina pectoris
* History of poorly controlled hypertension with anti-hypertensive regimen
* History of a sustained ventricular tachycardia
* Any history of ventricular fibrillation or Torsades de Pointes
* Right bundle branch block and left anterior hemiblock (bifasicular block)
* Bradycardia defined as heart rate < 50 beat per minutes* Concurrent severe and/or uncontrolled medical disease (i.e. uncontrolled diabetes, chronic renal disease, chronic liver disease, confirmed diagnosis of HIV infection or active uncontrolled infection).* Patients known to be HBV or HCV positive* Significant neurological or psychiatric disorder which could compromise participation in the study* Patient unwilling or unable to comply with the protocol* Patients who are not adequate to enter the study decided by the investigator from the medical point of view.
Other protocol-defined inclusion/exclusion criteria may apply. | 7,738 |
Study Objectives
Phase 3b of the research will be a laboratory experiment that uses an experimental and analytic design that is parallel to that used in Phase 3a, the online experiment. The primary objective of Phase 3b is to assess physiological response (i.e., eye tracking) to different message appeals of the audio-visual messages used in Phase 3a on respondents' behavioral intentions and UV-related behavioral choices post-exposure. Including time for preparation, viewing, and removal of the monitoring equipment, the message viewing session will take about 45 minutes per session.
Conditions: Behavior, Health
Intervention / Treatment:
BEHAVIORAL: Outdoor Sun Behavior, BEHAVIORAL: Indoor Tanning Behavior
| Inclusion Criteria:
* 18-49 year old non-Hispanic white (NHW) adults
* OR 18-25 year old NHW females who have tanned indoors in the past 12 months
Exclusion Criteria:
* | 18,586 |
Study Objectives
The purpose of this study is to determine the efficacy and safety of transplanting StemEx® in patients with certain hematological malignancies. For these patients, it is suggested that StemEx® can improve upon the outcome of transplanting a single, unmanipulated cord blood unit by significantly increasing the number of stem/progenitor cells available to the patient.
Conditions: Hematologic Malignancies, Acute Myeloid Leukemia, Lymphoid Leukemia, Chronic Myeloid Leukemia, Hodgkin's Disease, Non-Hodgkin's Lymphoma, Myelodysplastic Syndromes
Intervention / Treatment:
DRUG: StemEx®
| Inclusion Criteria:
* Clinical diagnosis of AML or ALL: CR2 or subsequent complete remission (CR) or CR1 with high-risk features or relapse with < 10% blasts in BM and no circulating blasts.* Clinical diagnosis of CML: in CP1 (Chronic Phase 1) and resistant or intolerant to Gleevec or in CP2 or subsequent CP or in accelerated phase.* Clinical diagnosis of HD: induction failure or relapse and sensitive to last chemotherapy course.* Clinical diagnosis of NHL induction failure or relapse and sensitive to last chemotherapy course.* Clinical diagnosis of MDS with intermediate 2- or high-risk IPSS score.
Exclusion Criteria:
* Less than twenty-one days have elapsed since the subject's last radiation or chemotherapy prior to conditioning (except Hydroxyurea).* HIV positive.* Pregnancy or lactation.* Uncontrolled bacterial, fungal or viral infection.* Subjects with signs and symptoms of active central nervous system (CNS) disease.* Availability of appropriate related and willing stem cell donor, who is HLA-matched at 5 or 6/6 antigens.* Prior allogeneic cell transplant.* Allergy to bovine or to any product, which may interfere with the treatment.* Enrolled in another clinical trial or received an investigational treatment during the last 30 days, unless approved by Sponsor. | 1,277 |
Study Objectives
To evaluate the risk of postoperative wound complications following the use of Avelle negative pressure wound therapy in patients undergoing mastectomy and flap fixation, which might serve as a basis for a randomized controlled trial
Conditions: Breast Cancer, Wound Complication, Wound Infection, Wound Dehiscence, Wound Necrosis
Intervention / Treatment:
DEVICE: Negative pressure wound therapy
| Inclusion Criteria:
* Older than 18 years
* Female sex
* Indication for mastectomy or modified radical mastectomy
Exclusion Criteria:
* Patients undergoing breast conserving therapy
* Patients undergoing direct breast reconstruction
* Unable to comprehend implications and extent of study and sign for informed consent
* Participation in other study | 28,127 |
Study Objectives
The purpose of this research study is to understand the effects of oral aspirin taken daily with an arginine-restricted diet on certain colorectal cancer biomarkers in treated colorectal cancer patients. Patients with colorectal cancer are at high risk for recurrence and for development of secondary colorectal cancers in the future. Specific chemicals (polyamines, prostaglandins) in the body referred to as biomarkers can be measured to help understand a person's risk for developing colorectal cancer. Specific biomarkers associated with colorectal cancer have been identified in prior laboratory studies. By measuring these predefined biomarkers before and after the study intervention, we can assess how they are affected by the intervention, and gain knowledge about their usefulness in colorectal cancer patients on clinical trial.
This study is a Phase IIa clinical biomarker study, using oral aspirin 325 mg taken daily with an arginine-restricted diet designed to reduce arginine intake by at least 30% during the 12-week study period. The biomarkers will be obtained from patient by performing endoscopy (a procedure used to look at the inside of the bowel, rectum and colon) and biopsy (taking samples of tissue), phlebotomy (drawing blood), and urine collection. Biopsies are done to evaluate changes in tissue content that may relate to early events in colon cancer formation. This was the procedure used to diagnose your condition initially. There will be 24 patients enrolled into this study performed through University of California Irvine Medical Center.
Conditions: Colorectal Cancer
Intervention / Treatment:
DRUG: Aspirin
| Inclusion Criteria:
* Subjects must be 18-80 years of age with a history of surgically removed colon or rectal cancer, and have received treatment for their disease using drugs (adjuvant chemotherapy)
* Subjects must have colon or rectal cancer with stage I, II, or III disease
* Subjects should not have further treatment with radiation therapy. Subjects having already received adjuvant (i.e., post-operative) radiation therapy to the colon or rectum will be excluded. However, subjects receiving radiation therapy prior to surgery for rectal cancer are eligible for enrollment.
* Subject's tumor must have been completely removed within the past 12 months, with first surveillance colonoscopy anticipated 12 weeks after study treatment start date (i.e. one-year after surgical removal).
* Subjects must be in good physical status
* If subjects are premenopausal and perimenopausal women, they must be using adequate birth control methods.
* Subjects must have no history of another invasive cancer within 5 years
* Subjects must have no further chemotherapy anticipated.
* Subjects don't have special dietary requirements or additives. Subjects must not be consuming a diet that would preclude taking the study medication.
* Subjects must have no concomitant use of calcium supplements (> 520mg/day).
* Subjects must have no history of abnormal wound healing or repair, or conditions that predispose to the same.
* Subjects don't have personal history of colon resection of or inflammatory bowel disease.
* Subjects must give informed consent via consent form approved by the local Human Subjects Committee (Institutional Review Board).
* If subjects are taking aspirin 81mg by mouth daily they will be eligible
* Subjects must have no history of allergies or adverse reactions to aspirin.
* Subjects don't have documented history of gastric/duodenal ulcer within the last 12 months.
Exclusion Criteria:
* Subjects already received radiation therapy to the colon or rectum.
* Subjects adhering to vegetarian diets.
* Subjects are pregnant or lactating women.
* Subjects are breastfeeding
* Subjects are already taking aspirin 325mg by mouth daily.
* Subjects are taking combination medication with more than 81mg aspirin.
* Subjects are currently being treated for gastric/duodenal ulcer or experiencing symptoms at study entry.
* Subjects have a history of any medical condition that would place them at risk as a result of a blood donation, they will be excluded from the study.
* Subjects are taking blood-thinning drugs as warfarin (Coumadin)
* Subjects are allergic to fenoprofen, ibuprofen, indomethacin, ketoprofen, meclofenamate sodium, naproxen, sulindac, tolmetin, or an orange food coloring known as tartrazine.
* Subjects have liver damage or severe kidney failure | 8,975 |
Study Objectives
This phase III trial is studying how well combination chemotherapy works in treating young patients with Down syndrome and acute myeloid leukemia or myelodysplastic syndromes. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
Conditions: Childhood Acute Basophilic Leukemia, Childhood Acute Eosinophilic Leukemia, Childhood Acute Erythroleukemia (M6), Childhood Acute Megakaryocytic Leukemia (M7), Childhood Acute Minimally Differentiated Myeloid Leukemia (M0), Childhood Acute Monoblastic Leukemia (M5a), Childhood Acute Monocytic Leukemia (M5b), Childhood Acute Myeloblastic Leukemia With Maturation (M2), Childhood Acute Myeloblastic Leukemia Without Maturation (M1), Childhood Acute Myelomonocytic Leukemia (M4), Childhood Myelodysplastic Syndromes, de Novo Myelodysplastic Syndromes, Secondary Acute Myeloid Leukemia, Secondary Myelodysplastic Syndromes, Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies
Intervention / Treatment:
DRUG: asparaginase, DRUG: daunorubicin hydrochloride, DRUG: cytarabine, DRUG: thioguanine, DRUG: etoposide, OTHER: laboratory biomarker analysis
| Inclusion Criteria:
* Diagnosis DS or DS mosaicism by karyotype or chromosomal analysis
* Diagnosis of myelodysplastic syndromes (MDS) with < 30% blasts or acute myeloid leukemia (AML)
* Newly diagnosed disease
* Patients with a history of transient myeloproliferative disorder (TMD) are eligible provided the patient is diagnosed with AML or MDS at > 90 days of age AND meets either of the following criteria:
* At least 30% blasts in the bone marrow regardless of time since resolution of TMD
* More than 8 weeks since resolution of TMD with ≥ 5% blasts in the bone marrow
* Immunophenotype required for study entry
* No promyelocytic leukemia
* Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by radionuclide angiogram
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST or ALT < 2.5 times ULN
* Creatinine adjusted according to age as follows:
* No greater than 0.4 mg/dL (≤ 5 months)
* No greater than 0.5 mg/dL (6 months -11 months)
* No greater than 0.6 mg/dL (1 year-23 months)
* No greater than 0.8 mg/dL (2 years-5 years)
* No greater than 1.0 mg/dL (6 years-9 years)
* No greater than 1.2 mg/dL (10 years-12 years)
* No greater than 1.4 mg/dL (13 years and over \[female\])
* No greater than 1.5 mg/dL (13 years to 15 years \[male\])
* No greater than 1.7 mg/dL (16 years and over \[male\])
* Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
* No evidence of dyspnea at rest
* No exercise intolerance
* Pulse oximetry > 94%
* No prior chemotherapy, radiotherapy, or any antileukemic therapy
* Intrathecal cytarabine therapy given at diagnosis allowed
* Prior therapy for TMD allowed | 20,161 |
Study Objectives
CPX-351 Real World Effectiveness and Safety Study (CREST UK) is a real-world evidence study designed to collect data on the potential benefits and/or risks of Vyxeos liposomal (liposomal daunorubicin/cytarabine; CPX-351) in routine clinical practice in the United Kingdom (UK).
Conditions: Acute Myeloid Leukemia
Intervention / Treatment:
DRUG: CPX-351
| Inclusion Criteria:
* Aged ≥18 years at the start of treatment of AML with Vyxeos liposomal
* Pathological diagnosis of t-AML or AML-MRC according to World Health Organization criteria (with at least 20% blasts in the peripheral blood or bone marrow)
* Patient has received at least one infusion of Vyxeos liposomal, prescribed as per the SmPC
* Patient signs an informed consent form or is included in accordance with an informed consent waiver
Exclusion Criteria:
* Treatment with Vyxeos liposomal as part of a clinical trial or managed access program
* Prior treatment intended for induction therapy of AML; only hydroxyurea is permitted for control of blood counts | 36,708 |
Study Objectives
The aim of this study was to evaluate the effect of preoperative nutritional status, dietary inflammatory index, and systemic inflammatory response on postoperative outcomes. The study will include 120 colorectal cancer patients who are scheduled for surgical treatment.
Conditions: Colorectal Cancer
Intervention / Treatment:
DIAGNOSTIC_TEST: Nutrition Risk Screening 2002 (NRS-2002), DIAGNOSTIC_TEST: Global Leadership Initiative on Malnutrition (GLIM), OTHER: Measurement of body composition with computed tomography (CT), DIAGNOSTIC_TEST: Dietary inflammatory index (DII), DIAGNOSTIC_TEST: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30), DIAGNOSTIC_TEST: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer 29 (EORTC-QLQ-CR29), DIAGNOSTIC_TEST: Prognostic Nutritional Index (PNI), DIAGNOSTIC_TEST: Neutrophil-Lymphocyte Ratio (NLR)
| Inclusion Criteria:
* Having been diagnosed with colorectal cancer and having surgical treatment planned
* Being 18 years of age or older
Exclusion Criteria:
* Having received chemotherapy or radiotherapy
* Currently undergoing corticosteroid or hormone treatment.
* Presence of distant metastases.
* Presence of any malignancy other than colorectal cancer.
* Presence of autoimmune disease.
* Presence of ongoing infectious disease. | 819 |
Study Objectives
The purpose of this study is to determine the effectiveness of self-hypnotic relaxation on mental and physical distress during and after tumor treatment procedures.
Conditions: Uterine Neoplasms, Leiomyoma
Intervention / Treatment:
BEHAVIORAL: Self-hypnotic relaxation
| Inclusion Criteria:
* Referred for transcatheter embolization for benign uterine fibroid tumor or radiofrequency ablation or chemoembolization for malignant tumors
* Able to hear and understand English
Exclusion Criteria:
* Impaired mental function
* Psychosis
* Severe chronic obstructive pulmonary disease
* Intolerance of midazolam or fentanyl
* Weigh less than 121 lbs
* Pregnancy | 46 |
Study Objectives
Primary Objectives:
1. To determine the efficacy of the topoisomerase I (topo I) inhibitor irinotecan, delivered via a low-dose protracted schedule to patients with advanced sarcoma.
2. To determine the toxicity profile of irinotecan, using a protracted schedule, in this pretreated patient population.
Conditions: Sarcoma
Intervention / Treatment:
DRUG: Irinotecan
| Inclusion Criteria:
* Patients of all ages.* Patients must have histologic proof of a sarcoma.* Patients must have locally advanced / metastatic disease that is inoperable or incurable with surgery.* If patient has a history of prior malignancy, there must be histologic documentation that metastatic disease is sarcoma.* Patients must have received or refused standard chemotherapy for disease.* Patients must have at least one lesion that is clearly defined, measurable or objectively evaluable. This lesion cannot have been previously irradiated unless progression has been demonstrated after radiation.* Patients must have a life expectancy of at least 12 weeks and a Zubrod performance status of < 2.* Patients must sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of this hospital. The only approved consent form is appended to this protocol.* Patients must receive no other concurrent chemotherapy or immunotherapies. Patients must have recovered from any previous chemotherapy. They must have been off treatment at least 4 weeks from the previous chemotherapy (6 weeks for stem cell toxins) and have recovered from any side effects or toxicity prior to the institution of irinotecan.* Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte counts of at least 1000/cubic mm and platelet count of at least 50,000/cubic mm determined within 2 weeks prior to the first treatment.* Patients should have adequate hepatic function with a bilirubin < 2 times the upper limit of normal, and Serum glutamic pyruvic transaminase (SGPT) < 3 times the upper limit of normal determined within 2 weeks prior to the first treatment.
Exclusion Criteria:
* Pregnant or lactating women will be excluded, due to unknown side effects on the fetus.* Patients with severe pulmonary insufficiency will be excluded.* Patients of childbearing potential not willing to utilize birth control during and for at least 3 months following completion of the trial shall not be eligible.* Patients with an overt psychosis or mental disability, those with psychological or social situation that would interfere with study follow-up, or otherwise incompetent to give informed consent shall be excluded from the study. | 6,482 |
Study Objectives
Although colorectal cancer is a preventable and curable disease if early stage tumors are removed, it is still the fourth cause of cancer worldwide and the second leading cause of death in many industrialized countries. The 5-year survival is about 55% often due to a late detection. Then, the identification of sensitive and specific molecular markers is therefore a major challenge for early diagnosis and prognosis of this disease.
Preliminary work have reported variations in the expression of DMBT1 (deleted in malignant brain tumor 1), a glycoprotein co-secreted with mucins in the light of the glands, during several stages of colon carcinogenesis. The goal of this study is to study by mass spectrometry (MS), alterations in the repertoire of glycosylation of mucins from colorectal tumors of various stages, grades, and recurrence status.
Conditions: DMBT1 Protein, Human, Colorectal Cancer
Intervention / Treatment:
OTHER: Detection of the expression of DMTB1 by immunohistochemistry
| Inclusion Criteria:
* for colon cancer: patients surgically treated for colorectal cancer at the Group of hospitals of the Catholic Institute of Lille.
* for adenomatous polyps : patients treated for adenomatous polyps at the Group of hospitals of the Catholic Institute of Lille.
* for controls: patients surgically treated for diverticular disease at the Group of hospitals of the Catholic Institute of Lille.
Exclusion Criteria:
* none | 24,683 |
Study Objectives
RATIONALE: Laparoscopic-assisted surgery and video-assisted thoracoscopy are less invasive types of surgery for esophageal cancer that may have fewer side effects and improve recovery.
PURPOSE: This phase II trial is studying how well laparoscopic-assisted surgery and video-assisted thoracoscopy work in treating patients who are undergoing esophagectomy for high-grade dysplasia of the esophagus or stage I, stage II, or stage III esophageal cancer.
Conditions: Esophageal Cancer
Intervention / Treatment:
PROCEDURE: Minimally invasive esophagectomy (MIE)
| INCLUSION CRITERIA:
DISEASE CHARACTERISTICS:
* High grade dysplasia of the esophagus who would undergo esophagectomy OR esophageal cancer at stage T1-T3, N0-N1 who require esophagectomy (patients with M1 disease and/or bulky lymph node involvement were excluded).
* Pathological confirmation of a diagnosis of cancer or high-grade dysplasia of the esophagus by biopsy.
* Computerized tomography (CT) scan of chest and abdomen within 6 weeks prior to registration
* Stomach must be available for conduit
* Age of 18 and over
* ECOG performance status of 0-2
* Creatinine less than 2 mg/dL
* Patients with esophageal cancer who would be treated with neoadjuvant chemotherapy and/or radiation were eligible. If patients were registered prior to receiving neoadjuvant chemotherapy they were allowed up to 5 months to complete therapy and any restaging that was necessary before operation was performed.
* The patient was considered an appropriate candidate for surgery based on preoperative clinical staging and physiological factors prior to registration as documented in the surgical plan. Pre-operative staging should include:
* Endoscopic ultrasound (EUS)
* Positron emission tomography (PET) scan and/or laparoscopic staging (Laparoscopic staging could be performed on the day of resection. Additional evaluation was recommended if the PET scan suggested distant metastatic disease.)
EXCLUSION CRITERIA:
* Cancer extending into the stomach more than 20%
* Prior anti-reflux or gastric operations
* Prior right thoracotomy
* Prior major neck operation other than the removal of superficial skin lesion | 15,685 |
Study Objectives
The HOW Study is a first-of-its-kind international online study for women and men with and without a history of breast cancer. The investigators will collect information about your health, your job, your diet, and your family history, among other topics that can help us get a better understanding of breast cancer and its potential causes. Periodically, the investigators will send you questionnaires about anything and everything. All you have to do is fill them out online. It's that simple. This is a partnership and the investigators need you for the long haul. The more questionnaires you fill out, the more information the investigators will have that can help us have a better understanding of why women get breast cancer.
Conditions: Breast Cancer
Intervention / Treatment:
| Inclusion Criteria:
* Men
* Women
* 18 years and older
Exclusion Criteria:
* Under the age of 18 | 22,676 |
Study Objectives
Laparoscopic prostatectomy (LP) is characterized by substantial tissue trauma, despite its minimally -invasive approach. Although postoperative pain intensity is lower when compared to open procedures, the use of opioids is common. Retrospective review of available LP cases revealed that although analgesic demand varied, nearly all of our LP patients required opioids postoperatively. Bilateral Quadratus Lumborum Block (QLB), being one of relatively new features of regional anesthesia, offers good analgesia of abdominal wall, with the potential for control of visceral pain. This study was established to evaluate its effectiveness in alleviating pain after radical prostatectomy in a double - blind, placebo - controlled manner.
Conditions: Prostate Cancer
Intervention / Treatment:
PROCEDURE: Qadratus Lumborum Block, DRUG: 30 milliliters of 0.375% Ropivacaine, DRUG: 30 milliliters of 0.9% NaCl
| Inclusion Criteria:
* ASA status less or equal 3
* Scheduled for transperitoneal or extraperitoneal endoscopic prostatectomy
* Able to understand information provided and to sign the informed consent for participation in the study
Exclusion Criteria:
* known allergy to local anesthetics and opioids
* infection in the area of block placement
* known chronic use of opioids, gabapentinoids and tricyclic antidepressants
* mental inability to understand the principles and rules of patient-controlled analgesia pump | 6,354 |
Study Objectives
This is a retrospective study on bladder cancer in French painters' population. The French agency ANSES collected data from all occupational and environmental diseases center in a specific database called RNV3P. We selected cases of bladder cancer in painters in four centers from 01/01/2010 to 31/12/2019. Those cases were analyzed in terms of occupational exposure, histology and sociodemographics data. Comparison between different histologic types of cancer, workplaces and occupational diseases process will be done.
Conditions: Bladder Cancer
Intervention / Treatment:
| Inclusion Criteria:
* painters
* age> 18 years
* data from one of the French occupational diseases centers
* approval letter
Exclusion Criteria:
* non-approval letter
* age < 18 years | 10,089 |
Study Objectives
The main purpose of this study is to examine the side effects that participants with metastatic breast cancer experience when taking abemaciclib with or without food.
Conditions: Metastatic Breast Cancer
Intervention / Treatment:
DRUG: Abemaciclib
| Inclusion Criteria:
* Have a diagnosis of HR+, HER2- metastatic breast cancer (mBC).
* Have all of the following:
* Recurrent, locally advanced, unresectable or mBC with disease progression following anti-estrogen therapy.
* Prior treatment with chemotherapy for locally advanced or metastatic disease.
* No prior treatment with cyclin-dependent kinases (CDK) 4 and 6 inhibitor.
* Have Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1.
* Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy.
* Have adequate organ function.
* Women of child-bearing potential must have a negative pregnancy test.
* Are able to swallow tablets/capsules.
Exclusion Criteria:
* Are currently receiving treatment in a clinical study involving an investigational product.
* Have a serious concomitant systemic disorder.
* Have symptomatic central nervous system (CNS) malignancy or metastasis.
* Have a symptomatic Human Immunodeficiency Virus (HIV) infection or symptomatic activated/reactivated hepatitis A, B, or C.
* Have a personal history of syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.
* Have a history of any other cancer.
* Had major surgery within 14 days prior to randomization.
* Are breastfeeding.
* Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively. | 17,017 |
Study Objectives
Febrile neutropenia requires prompt initiation of broad-spectrum antibiotics, which can be responsible for side-effects and selection of resistance. This study demonstrates the safety of an early discontinuation of empirical treatments, in carefully selected patients presenting with fever of unknown origin.
Conditions: Febrile Neutropenia, Hematological Malignancy
Intervention / Treatment:
OTHER: ECIL-4 guidelines group, OTHER: Short-course antibiotic therapy
| Inclusion Criteria:
* age ≥ 18 years;
* presence of a malignant haematological disease combined with chemotherapy-induced neutropenia (polymorphonuclear neutrophil (PMN) count ≤ 500/mm3)
* fever defined by tympanic temperature of ≥38°C for ≥1 hour or a single temperature of ≥38.3°C
Exclusion Criteria:
* Patients without curative care
* chronic neutropenia (PMN≤ 500/mm3 for 3 months or more) | 31,205 |
Study Objectives
This study aimed to search whether whole body and subcutaneous adipose tissues increase in PCOS patients and whether these tissues are related to HOMA-IR and plasma adiponectin levels.
Conditions: Polycystic Ovary Syndrome
Intervention / Treatment:
| Inclusion Criteria:
* All of the women with PCOS had normal thyroid-stimulating hormone and prolactin (PRL) levels.
Exclusion Criteria:
* Subjects with possible ovarian tumors, congenital adrenal hyperplasia, BMI greater than 35 kg/m2, any chronic renal or liver disease, were excluded from the study. | 12,315 |
Study Objectives
The incidence of hepatocellular carcinoma (HCC) has recently increased in the United States. Although imaging plays a major role in HCC screening and staging, the possibility of predicting HCC tumor grade, aggressiveness, angiogenesis and hypoxia with imaging are unmet needs. In addition, new antiangiogenic drugs now available to treat advanced HCC necessitate the use of new imaging criteria beyond size. The investigators would like to develop and validate non-invasive magnetic resonance imaging (MRI) methods based on advanced diffusion-weighted imaging (DWI), MR Elastography, BOLD (blood oxygen level dependent) MRI and perfusion-weighted imaging (PWI, using gadolinium contrast) to be used as non-invasive markers of major histopathologic features of HCC, and to predict and assess early response of HCC to systemic therapy. The investigators also would like to develop quality control tools to improve the quality and decrease variability of quantitative MRI metrics. These techniques combined could represent non-invasive correlates of histologic findings in HCC, could enable individualized therapy, and provide prognosis in patients with HCC.
Conditions: Hepatocellular Carcinoma, HCC
Intervention / Treatment:
DEVICE: Magnetic Resonance Imaging
| Inclusion Criteria:
Study group
* Patients diagnosed with HCC, who will undergo resection or transplantation within 6 months, as part of routine clinical care and patients diagnosed with unresectable HCC
* 18 years of age and older
* Patient is able to give informed consent for this study
Control group
* Healthy volunteers 18 years of age and older
* Subject is able to give informed consent for this study
Exclusion Criteria:
* Age less than 18 years
* Unable or unwilling to give informed consent
* Contra-indications to MRI:
1. Electrical implants such as cardiac pacemakers or perfusion pumps
2. Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants
3. Ferromagnetic objects such as jewelry or metal clips in clothing
4. Pregnant subjects
5. Pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions | 38,416 |
Study Objectives
The purpose of this study is to help us learn how to lower the risk of a blood transfusion during surgery to remove ovarian cancer. Acute normovolemic hemodilution (ANH) is a technique performed in the operating room before the procedure begins that may reduce the risk of needing a transfusion during ovarian cancer surgery. During surgery, the patient's own blood is given back to them when needed, usually due to bleeding. If you don't need blood during surgery, your own blood will be given back at the end of the case.
The idea behind ANH is that that by removing the blood and replacing it with other fluids, the remaining blood becomes diluted. This diluted blood is then lost during surgery, usually due to bleeding. The original non-diluted blood is then transfused back as needed. This may mean a lower chance of needing an additional blood transfusion.
ANH has been studied at this hospital for other types of cancer. These studies suggest that ANH may help conserve blood. Although most studies suggest that ANH can be performed safely, one study showed that ANH could be associated with a higher rate of serious bowel complications than standard treatment. In this study, patients who underwent ANH had a higher rate of anastomotic leaks during bowel surgery. An anastomotic leak occurs when two ends of bowel that have been cut and sewn back together (the anastomosis), fall apart. The investigators don't know whether ANH will result in higher rates of anastomotic leaks in patients having ovarian cancer surgery. In fact, in another study evaluating ANH in patients having the kind of bowel resections that often occur in ovarian cancer surgery (the colon), no increased risk of anastomotic leaks was observed. For these reasons, researchers at MSKCC are conducting a study to find out if ANH can be used safely in patients undergoing surgery for ovarian cancer.
Conditions: Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
Intervention / Treatment:
PROCEDURE: Acute Normovolemic Hemodilution
| Inclusion Criteria:
* The study population will include women with a high preoperative suspicion of advanced primary epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (Stage IIIC or IV) as determined by CT or MRI of abdomen and pelvis planning to undergo exploratory laparotomy and surgical cytoreduction with the operative goal of this procedure to achieve optimal cytoreduction to less than 1 cm of residual disease.
* Age ≥ 18 years and < 70 years.
* Preoperative hemoglobin concentration ≥ 10 mg/dL within 30 days of registration.
* Based on surgeon's assessment, patient is recommended to undergo cytoreductive surgery via laparotomy with the operative goal of this procedure to achieve optimal cytoreduction to less than 1 cm of residual disease.
Exclusion Criteria:
* Hemoglobin < 10 g/dL.
* Serum albumin < 3g/dL.
* GOG performance status > 2.
* Active coronary artery disease (defined as unstable angina or a positive cardiac stress test).
* Patients with a history of coronary artery disease may be included if they have had a normal cardiac stress test within 30 days of enrollment.
* History of cerebrovascular disease.
* Renal insufficiency with serum creatinine > 1.6.
* Uncontrolled hypertension.
* Restrictive or obstructive pulmonary disease.
* Congestive heart failure.
* Active infection.
* Pregnancy.
* Refusal to accept allogenic or autologous blood transfusion.
* Autologous blood transfusion within last 30 days or plan to donate autologous blood prior to surgery.
* Plan for exploratory laparoscopy prior to laparotomy for assessment of disease resectability.
* Surgeon has high suspicion (>50% chance) that cytoreductive surgery will be aborted due to inability to achieve optimal cytoreduction to < 1cm residual disease. | 30,799 |
Study Objectives
This trial is a study on all-trans retinoic acid in combination with induction and consolidation therapy as well as pegfilgrastim after consolidation therapy in younger patients with newly diagnosed acute myeloid leukemia (AML).
Conditions: Acute Myeloid Leukemia
Intervention / Treatment:
DRUG: Cytarabine, DRUG: Idarubicin, DRUG: Etoposide, DRUG: All-trans retinoic acid, DRUG: Pegfilgrastim
| Inclusion Criteria:
* Newly diagnosed AML defined according to the World Health Organization (WHO)-classification (excluding acute promyelocytic leukemia \[APL\])
* Ages 18-60 years
* Written informed consent of each patient at study entry.
* Molecular and cytogenetical diagnostics on initial bone marrow and peripheral blood specimen at the central reference laboratories
Exclusion Criteria:
* Bleeding independent of the AML
* Acute promyelocytic leukemia
* Uncontrollable infection
* Participation in a concurrent clinical study
* Insufficiency of the kidneys (creatinine > 1.5x upper normal serum level), of the liver (bilirubin, AST or AP > 2x upper normal serum level), severe obstructive or restrictive ventilation disorder, heart failure New York Heart Association (NYHA) III/IV
* Severe neurological or psychiatric disorder interfering with ability to give an informed consent.
* No consent for registration, storage and processing of the individual disease-characteristics and course.
* Performance status WHO > 2
* Pregnancy | 29,013 |
Study Objectives
This registry will collect data from patients routinely undergoing an ERCP and Cellvizio endomicroscopy procedure (and optionally an additional cholangiopancreatoscopy procedure) due to suspected pancreatic or bile duct cancer. The objective is to determine if endomicroscopy images collected using the marketed Cellvizio device may help endoscopists more accurately diagnose, in conjunction with traditional tissue sampling techniques, whether a suspected lesion is malignant or benign.
Conditions: Pancreatic Cancer, Bile Duct Cancer
Intervention / Treatment:
DEVICE: Probe-based confocal laser endomicroscopy
| Inclusion Criteria:
* Male or female > 18 years of age* Willing and able to comply with Registry procedures and provide written informed consent to participate in the Registry* Indicated for ERCP and/or cholangiopancreatoscopy* Indeterminate or suspected biliary and/or pancreatic stricture, mass, or neoplasm
Exclusion Criteria:
* Subjects for whom ERCP procedures are contraindicated* Known allergy to fluorescein dye | 29,236 |
Study Objectives
The primary objective of the study is to identify the highest dose of gemcitabine that can be given safely with cisplatin and pelvic intensity modulated radiation therapy (IMRT) in women with locally advanced cervical cancer. The investigators hypothesis is that IMRT will reduce gastrointestinal and hematologic toxicity, permitting escalating doses of gemcitabine to be feasibly delivered in patients with locally advanced cervical cancer.
Conditions: Cervical Carcinoma
Intervention / Treatment:
RADIATION: Intensity Modulated Radiation Therapy (IMRT), DRUG: Cisplatin, DRUG: Gemcitabine
| Inclusion Criteria:
* Diagnosis: Histologically-proven, invasive primary carcinoma of the cervix.
* Disease Status: Stage IB2-IVA cervical cancer or stage I with biopsy-proven pelvic node metastases, positive surgical margins, or parametrial extension based upon standard diagnostic workup, including:
* History/physical examination
* Examination under anesthesia (if indicated)
* Biopsy
* Intravenous pyelogram and/or cystoscopy (if indicated)
* Colonoscopy, sigmoidoscopy, or rigid proctoscopy (if indicated)
* PA and lateral chest x-ray or chest CT
* CT or MRI of the pelvis
* PET, PET/CT, or PET/CT simulation (encouraged)
* Performance Level: Karnofsky Performance Status ≥ 60 - Peripheral ≥ ANC 1500/uL
* Platelet count ≥ 100,000/uL (transfusion independent)
* Hemoglobin ≥ 8.0 g/dL (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dL is acceptable)
* Serum creatinine ≤ 1.5 mg/dl
* Bilirubin (sum of conjugated + unconjugated) < 1.5 mg/dl, and
* SGPT (ALT) < 1.5 x upper limit of normal (ULN) for age, and
* SGOT (AST) < 1.5 x upper limit of normal (ULN) for age
Exclusion Criteria:
* Pregnancy or Breast-Feeding: Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events.(Note: Serum Pregnancy tests must be obtained in women of child bearing potential). Sexually active females may not participate unless they have agreed to use an effective contraceptive method (such as abstinence, diaphragm, condom, or intrauterine device) to prevent pregnancy for the duration of the study.
* Concomitant Medications, if taken within the last 28 days.
* Growth factor(s): Growth factors that support platelet or white cell number or function must not have been administered within the past 28 days.
* Erythropoietic drug(s): Erythropoietin or related hormones must not have been administered within the past 28 days.
* Infection: Patients who have an uncontrolled infection.
* Evidence of para-aortic lymphadenopathy or distant metastases
* Prior invasive malignancy (except non-melanomatous skin cancer), unless disease free for a minimum of 3 years.
* Prior systemic chemotherapy within the last three years.
* Prior radiotherapy to the pelvis
* Allergic to iodinated contrast if undergoing a contrast enhanced CT scan of the pelvis | 12,560 |
Study Objectives
Cervical spine tumor is a small sample of tumor disease with low incidence, great harm, and complex anatomical structure. It is very difficult to identify and classify benign and malignant cervical spine tumors clinically.
The deep learning model we constructed in the early stage has a higher accuracy rate for the image diagnosis of cervical spondylosis with a large number of cases, and a better clinical application effect, but the accuracy rate for cervical spine tumors with a small number of cases is lower. The reason may be the amount of data. With limited tasks, the traditional deep learning model is difficult to play an effective role.
Based on this, we propose to build a small sample-oriented deep learning model to assist clinicians in the diagnosis of cervical spine tumors with multimodal images, and to evaluate the benign and malignant tumors.
Conditions: Spine Tumor
Intervention / Treatment:
| Inclusion Criteria:
* 18-50 years old, about 300 males and females; in the orthopedics outpatient and emergency department of our hospital, the imaging scans (X-ray, CT, MR) showed no obvious abnormalities.
Exclusion Criteria:
* have had surgery before acquiring the images, Those who have cervical spine fractures, deformities, infections, etc. who cannot cooperate with imaging examinations, and those who have not signed the informed consent. The normal control group" includes about 600 patients with normal or slightly degenerated cervical spine, as a standard for training computers to recognize cervical spine structures Images and control images for detecting tumor lesions. | 22,494 |
Study Objectives
The purpose of this study was to assess the efficacy and safety of everolimus in the treatment of advanced pancreatic neuroendocrine tumor (NET) not responsive to cytotoxic chemotherapy. All patients were treated with everolimus until either tumor progression was documented using a standard criteria that measures tumor size called Response Evaluation Criteria in Solid tumors (RECIST), or until unacceptable toxicity occurred, or until the patient or investigator requested discontinuation of treatment.
Conditions: Islet Cell Carcinoma, Neuroendocrine Carcinoma, Neuroendocrine Tumor, Pancreatic Neoplasms
Intervention / Treatment:
DRUG: Everolimus 10 mg, DRUG: Octreotide Depot
| Inclusion criteria for both strata:
* Advanced (unresectable or metastatic) biopsy-proven pancreatic Neuroendocrine tumor (NET)
* Confirmed low-grade or intermediate-grade neuroendocrine carcinoma
* Objective disease progression by Response Evaluation Criteria in Solid tumors (RECIST) criteria while receiving cytotoxic chemotherapy or at any time after receiving an adequate course of cytotoxic chemotherapy (i.e., at least 3 consecutive cycles or months of treatment with the same cytotoxic drug or regimen)
* Presence of at least one measurable disease using RECIST criteria at screening (computer tomography \[CT\] or Magnetic resonance imaging \[MRI\])
* Adequate bone marrow, liver and kidney function
* WHO Performance Status 0-2.
Inclusion criteria for Stratum 2 only:
* Meet all inclusion criteria defined above for both strata.
* Receiving treatment (at least 3 consecutive months) with Octreotide Depot.
* In addition to documentation of progressive disease on or after chemotherapy, patients in stratum 2 must have documented objective progression of disease while receiving Octreotide Depot.
Exclusion criteria for both strata:
* Anticancer therapy within 3 weeks of enrollment.
* Patients with poorly differentiated neuroendocrine carcinoma
* Hepatic artery embolization within the last 6 months
* Prior therapy with everolimus or other rapamycins (sirolimus, temsirolimus)
* Other concurrent malignancy
* Other serious intercurrent infections or nonmalignant uncontrolled medical illnesses
Exclusion Criterion for Stratum 1 only:
* Received treatment with Octreotide Depot or any other long-acting somatostatin analogue in the 60 days prior to enrollment or any short-acting somatostatin analogue in the two weeks prior to enrollment.
Other protocol-defined inclusion/exclusion criteria applied. | 37,152 |
Study Objectives
RATIONALE: Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving more than one drug (combination chemotherapy) together with everolimus may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of cisplatin, paclitaxel, and everolimus when given together for the treatment of patients with metastatic breast cancer.
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: cisplatin, DRUG: everolimus, DRUG: paclitaxel
| Inclusion Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed invasive mammary carcinoma
* Stage IV disease
* No locally recurrent breast cancer
* Patients with HER2/neu overexpressing tumors must have received prior trastuzumab (Herceptin®) in first-line treatment of metastatic breast cancer
* Patients with estrogen receptor- or progesterone receptor-expressing tumors must have received prior endocrine therapy (i.e., aromatase inhibitors, fulvestrant, tamoxifen, or ovarian ablation) in first-line treatment of metastatic breast cancer
* No symptomatic brain metastases
* Patients with a history of brain metastases must be clinically stable and not taking steroids or therapeutic anticonvulsants that are CYP3A4 modifiers
* Patients with asymptomatic brain metastases on prophylactic convulsants that are CYP3A4 modifiers are not eligible
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Menopausal status not specified
* ECOG performance status 0-1
* Life expectancy ≥ 6 months
* ANC ≥ 1000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Creatinine ≤ 1.5 times upper limit of normal (ULN)
* Bilirubin ≤ 1.5 times ULN (3 times ULN if liver metastasis present)
* SGOT and SGPT ≤ 1.5 times ULN (3 times ULN if liver metastasis present)
* Alkaline phosphatase ≤ 3 times ULN if liver metastasis present
* Able to swallow and retain oral medication
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after completion of study treatment
* Must be disease-free from prior invasive cancers for > 5 years with the exception of completely resected basal cell or squamous cell carcinoma of the skin or successfully treated cervical carcinoma in situ
* No malabsorption syndrome, disease significantly affecting gastrointestinal function, or ulcerative colitis
* No uncontrolled intercurrent illness including, but not limited to:
* Ongoing or active infection requiring parenteral antibiotics
* Impairment of lung function (i.e., chronic obstructive pulmonary disease or lung conditions requiring oxygen therapy)
* Symptomatic New York Heart Association class III-IV congestive heart failure
* Unstable angina pectoris, angioplasty, stenting, or myocardial infarction within the past 6 months
* Uncontrolled hypertension (systolic blood pressure \[BP\] > 180 mm Hg or diastolic BP > 100 mm Hg)
* Clinically significant cardiac arrhythmia (i.e., multifocal premature ventricular contractions, bigeminy, trigeminy, or ventricular tachycardia that is symptomatic or requires treatment)
* Uncontrolled diabetes
* Psychiatric illness/social situations that would preclude compliance with study requirements
* No known history of uncontrolled or symptomatic neuropathy ≥ grade 2
* No hypersensitivity to paclitaxel, or drugs using the vehicle Cremophor, Chinese hamster ovary cell products, or other recombinant human antibodies
Exclusion Criteria:
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Recovered from all prior treatment
* Must not have exceeded a total cumulative dose of life-time exposure of doxorubicin hydrochloride ≤ 360 mg/m² or epirubicin hydrochloride ≤ 640 mg/m²
* At least 2 weeks since other prior investigational drugs
* No prior resection of the stomach or small bowel
* No more than 4 prior chemotherapy regimens in the metastatic setting
* This restriction does not include endocrine therapies or single agent biologic therapies (i.e., trastuzumab)
* Concurrent radiotherapy to painful bone metastases or areas of impending bone fracture allowed as long as radiotherapy is initiated prior to study entry
* No concurrent trastuzumab
* No concurrent endocrine therapy
* No concurrent CYP3A4 modifiers
* No concurrent herbal supplement
* No other concurrent anticancer therapy (chemotherapy, radiotherapy, surgery, immunotherapy, hormonal therapy, or biological therapy) | 25,655 |
Study Objectives
RATIONALE: Aldesleukin may stimulate the white blood cells to kill tumor cells. Vaccines may help the body build an effective immune response to kill tumor cells. Giving aldesleukin together with vaccine therapy may kill more tumor cells. It is not yet known whether aldesleukin is more effective with or without vaccine therapy in treating melanoma.
PURPOSE: This randomized phase II trial is studying how well aldesleukin works when given with or without vaccine therapy in treating patients with stage IV melanoma.
Conditions: Stage IV Melanoma
Intervention / Treatment:
BIOLOGICAL: aldesleukin, BIOLOGICAL: allogeneic large multivalent immunogen vaccine
| Inclusion Criteria:
* Stage IV melanoma.
* Prior systemic chemotherapy, immunotherapy, or biological therapy is allowed if at least 4 weeks since last treatment. Patient must recover from the acute toxic effects of the treatment prior to study enrollment.
* Disease status must be that of measurable or nonmeasurable disease as defined by Solid Tumor Response Criteria (RECIST)
* Karnofsky performance status >70% (Eastern Cooperative Oncology Group 0-1)
* Age 18 years or older
* Adequate organ function within 14 days of study enrollment including the following:
* Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) ≥ 1.5 x 10\^9/L, platelets ≥100 x 10\^9/L, and hemoglobin ≥ 10 g/dL
* Hepatic: bilirubin < 3 times the upper limit of normal (× ULN), aspartate transaminase (AST) < 3 × ULN
* Renal: creatinine ≤ 2.0
* Must share at least one class I HLA allele with the HLA-type SK23-CD80+ cell (class I alleles (A1, A2, B7, B8, C7))
* Meets eligibility criteria for and agrees to enroll in "MT1999- 06: Vaccination with Tetanus Toxoid and Keyhole Limpet Hemocyanin (KLH) to Assess Antigen-Specific Immune Responses" (IRB # 9904M01581, CPRC #2002LS032)
* Women of childbearing potential and men whose partners are of childbearing potential are required to use an effective method of contraception (ie, a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) during the study and for 3 months after the last dose of study drug.
* Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
Exclusion criteria:
* History of brain metastases or positive brain scan at on-study
* Immunosuppressive therapy i.e., prednisone or organ transplant patients, however topical or inhalational steroids are allowed.
* Autoimmune diseases requiring immunosuppressive therapy.
* History of symptomatic pulmonary disease will have pulmonary function tests (PFTs) performed. Patients with symptoms of dyspnea or rales, wheezes or rhonchi on physical exam will undergo PFTs. Those with FEV1 <50% of predicted or corrected DLCO <50% are not eligible.
* Patients with cardiac disease such as recent myocardial infarction (< 3 months prior), unstable angina, or heart failure requiring medical intervention will undergo cardiac evaluation. Cardiac testing may include ECG, MUGA or echocardiogram, and/or thallium stress test as indicated to evaluate cardiac risks. Those patients with exercise-induced ischemia or an ejection fraction by MUGA or echocardiogram < 40% are not eligible.
* Due to the origin of the KLH protein, patients with a history of seafood allergy are excluded from receiving KLH.
* Hypersensitivity to any component of the vaccine, including Thimerosal, a mercury derivative, is a contraindication (taken from tetanus toxoid package insert).
* The occurrence of any type of neurologic symptoms to tetanus vaccine in the past is a contraindication to further use (taken from tetanus toxoid package insert).
* Subjects who have had tetanus toxoid within the last 7 years will not receive the tetanus vaccine component of this
* Pregnant (positive pregnancy test) or lactating women. Use of LMI vaccine during pregnancy is not approved for use by the FDA during pregnancy. IL-2 is pregnancy category C - risk in pregnancy cannot be ruled out. | 18,684 |
Study Objectives
The dose-confirming part of this study, comprising at least 10 patients is designed as a single center, prospective, single arm, open label in patients who have failed or are unresponsive to Azacitidine (AZA) or Decitabine (they may also have additionally failed an Erythropoiesis Stimulating Agent (ESA) followed by a dose expansion part with at least 44 patients; the objective of the whole study being to assess the safety, efficacy, pharmacokinetics and pharmacodynamics of intravenously infused multiple doses of OPN-305 in low and intermediate-1 risk myelodysplastic syndrome (second and third line Lower risk MDS).
Conditions: Myelodysplastic Syndrome
Intervention / Treatment:
DRUG: OPN-305
| Inclusion Criteria:
* Written informed consent
* Age ≥ 18 years
* Diagnosis of MDS (de novo or secondary) by bone marrow aspirate based on the World Health Organization (WHO) classification - Low and Intermediate-1 risk categories MDS using the IPSS (International Prognostic Scoring System)
* AZA/decitabine (this applies to standard of care and investigational drugs) failure (Dose confirming and Dose expansion parts):
* defined as discontinuation due to any of the following:
* Lack of response after at least 4 cycles
* Loss of response (patient must have received therapy for at least 4 cycles)
* Progressive disease
* Adverse events
Note: Patients are eligible if additionally they have failed an ESA
* HMA Naïve group:
* Never received a hypomethylating agent for MDS
* Failed or ceased to respond to ESA(s)
* ESA ineligible; defined as endogenous serum erythropoietin level > 200 U/L for subjects not previously treated with ESAs
* Red blood cell transfusion dependent defined as ≥ 2 Red blood cells (RBC) units required in the 8 weeks prior to starting in the study. In addition, there should be no 8 consecutive weeks without red blood cell transfusions in the 16 weeks prior to enrolment.
* Life expectancy ≥ 3 months
* Eastern Cooperative Oncology Group (ECOG) performance status Grade 0-2
* Serum bilirubin levels ≤2 x upper limits of normal (ULN)
* Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels ≤2.5 x ULN
* Del 5q patients who have failed or are not eligible for Revlimid
* Creatinine clearance >30 ml/min calculated by the Cockcroft-Gault formula
* Willingness to comply with the protocol procedures for the duration of the study, including scheduled follow-up visits and examinations
* Negative urine β-human chorionic gonadotropin (β-HCG) pregnancy test for fertile women at screening and confirmed by serum pregnancy test in the 48 hours prior to OPN-305 administration
* If sexually active female, patient must be/have one of the following:
* Post-menopausal defined as the absence of menses for at least one year (serum Follicle-stimulating hormone (FSH) ≥20IU/L can also be measured according to local practice),OR
* Surgically sterile defined as a bilateral tubal ligation at least 6 months prior to administration of study drug, bilateral oophorectomy, or complete hysterectomy, OR
* Using an effective means of contraception that is planned to continue for the duration of treatment and for a further 3 months.
* If sexually active male, patient must: Agree to use an effective means of contraception (per site-specific guidelines) that is planned to continue until 6 months after the last dose of OPN-305.Agree not to donate sperm until 6 months after the last dose of OPN-305
Exclusion Criteria:
* Diagnosis of MDS by bone marrow aspirate of Intermediate-2 and High risk category MDS based on the World Health Organization (WHO) classification using the IPSS (International Prognostic Scoring System)
* Patients with 5q deletion (del) MDS eligible for Revlimid (lenalidomide)
* Hypomethylating agent (HMA) Naïve group:
* Have received a hypomethylating agent for MDS
* Have not failed or ceased to respond to an ESA
* Are not ESA ineligible as defined in inclusion criteria
* Prior history of acute leukemia or AML
* Unable/unwilling to undergo bone marrow sampling
* Prior history of bone marrow transplantation
* Prior malignancy (other than non-invasive malignancy including in situ cervical cancer, Bowen's disease, basal cell cancer of the skin and non-invasive or excised skin squamous cell carcinoma) unless treated with curative intent and without evidence of disease for 3 years before randomization
* Active viral or bacterial infections: this includes any infections that are being actively treated even if the signs and symptoms appear to have resolved. Courses of antibiotics or anti-viral treatment should be completed before the patients is enrolled
* Unstable angina, congestive heart failure \[NYHA (New York Heart Association) >class II\], uncontrolled hypertension \[diastolic > 100 mmHg\], uncontrolled cardiac arrhythmia, or recent (within 1 year) myocardial infarction, uncontrolled diabetes mellitus
* Clinical Evidence of Central Nervous System (CNS) disease
* Less than 4 weeks since any therapy for MDS
* Prior history of anaphylaxis to similar products
* History or presence of a medical condition or disease or substance abuse that in the investigator's assessment would place the patient at an unacceptable risk for study participation
* Lactating or pregnant woman | 1,065 |
Study Objectives
The purpose of this study is to test the safety and efficacy of the combination of erlotinib hydrochloride (Tarceva™) and sirolimus (Rapamune™) in the treatment of patients with metastatic kidney cancer.
Conditions: Renal Cell Carcinoma
Intervention / Treatment:
DRUG: Erlotinib hydrochloride, DRUG: Sirolimus
| Inclusion Criteria:
* Signed informed consent to participate in this study.
* Histological diagnosis of renal cell carcinoma.
* Age greater or equal 18 years.
* Eastern Cooperative Oncology Group (ECOG) Performance status of 2 or better.
* Life expectancy of at least 3 months.
* Failure or intolerance to previous treatment with Sutent® and/or Nexavar®.
* Most recent systemic treatment at least 1 month from the beginning of treatment.
* Most recent local treatment (surgery or irradiation) > 2 weeks from the beginning of treatment.
* At least one site of measurable disease by CT scan or MRI (RECIST criteria).
* Baseline hemoglobin >9 g/dl, platelets > 100,000/mm3, absolute neutrophil count (ANC >1500/mm3.
Exclusion Criteria:
* Previous treatment with Tarceva™, Iressa™, Rapamune™, temsirolimus or everolimus.
* Untreated metastasis to the central nervous system.
* Previous solid organ, bone marrow or stem-cell transplant.
* Known AIDS or HIV infection.
* Symptomatic or poorly controlled chronic heart failure.
* Chronic renal failure requiring dialysis on a regular basis.
* Chronic liver failure.
* Serum aspartate aminotransferase (AST), Alanine Aminotransferase (ALT), alkaline phosphatase or bilirubin >1.5 x the upper limit of normal for the local laboratory.
* Pregnant or breast-feeding women.
* Other invasive malignant diseases within 5 years (other than squamous or basal cell carcinoma of the skin).
* Inability to provide informed consent
* Any other serious and/or unstable medical, psychiatric, or other condition considered by the P.I. to preclude safe or reasonably compliant participation in the protocol. | 2,664 |
Study Objectives
This phase I/II trial studies the side effects and best dose of talazoparib and temozolomide and to see how well they work in treating younger patients with tumors that have not responded to previous treatment (refractory) or have come back (recurrent). Talazoparib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving talazoparib together with temozolomide may work better in treating younger patients with refractory or recurrent malignancies.
Conditions: Adult Solid Neoplasm, Childhood Solid Neoplasm, Recurrent Childhood Central Nervous System Neoplasm, Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Recurrent Malignant Solid Neoplasm, Refractory Central Nervous System Neoplasm
Intervention / Treatment:
OTHER: Laboratory Biomarker Analysis, OTHER: Pharmacological Study, DRUG: Talazoparib, DRUG: Temozolomide
| Inclusion Criteria:
* Age:
* Phase 1 (Part A)
* Patients must be > than 12 months and =< 21 years of age at the time of study enrollment
* Phase 2 (Part B)
* Patients must be > than 12 months and =< 30 years of age at the time of study enrollment
* Body surface area (for Parts A and B):
* Patients must have a body surface area (BSA) of >= 0.42 m\^2 at the time of study enrollment
* Diagnosis:
* Phase 1 (Part A)
* Solid tumors (Part A1): patients with relapsed or refractory solid tumors including central nervous system (CNS) tumors without bone marrow involvement are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG)
* Ewing sarcoma or peripheral primitive neuroectodermal tumor (PNET) (Part A2): patients with relapsed or refractory Ewing sarcoma or peripheral PNET without bone marrow involvement will be eligible for Part A2 if there are no available slots on Part A1; these patients will be enrolled at one dose level below the dose level at which patients on Part A1 are actively enrolling, or at the starting dose level (dose level 1) if dose escalation has not yet occurred; patients must have had histologic verification of malignancy at original diagnosis or relapse
* Phase 2 (Part B)
* Ewing sarcoma or peripheral PNET: patients with relapsed or refractory Ewing sarcoma or peripheral PNET are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse
* Phase 2 (Part C)
* Disease status:
* Phase 1 (Part A):
* Patients must have either measurable or evaluable disease
* Phase 2 (Part B):
* Ewing sarcoma or peripheral PNET: patients must have measurable disease
* Therapeutic options: patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
* Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age; Note: neurologic deficits in patients with CNS tumors must have been relatively stable for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
* Patients who have received prior therapy with a temozolomide-based regimen are eligible; Note: patients who have progressed on a poly adenosine diphosphate ribose polymerase (PARP) inhibitor and temozolomide regimen are not eligible for Part A of the study
* Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy
* Myelosuppressive chemotherapy:
* Solid tumors (Part A and Part B): at least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)
* Hematopoietic growth factors: at least 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair
* Biologic (anti-neoplastic agent): at least 7 days after the last dose of a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair
* Immunotherapy: at least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines
* Monoclonal antibodies: at least 3 half-lives of the antibody after the last dose of a monoclonal antibody
* Radiation therapy (XRT): at least 14 days after local palliative XRT (small port); at least 42 days must have elapsed if other substantial bone marrow (BM) radiation; patients with prior total body irradiation (TBI), craniospinal XRT and/or >= 50% radiation of the pelvis are not eligible
* Stem cell infusion without TBI: no evidence of active graft vs. host disease and at least 84 days must have elapsed after transplant or stem cell infusion
* PARP inhibitor exposure:
* Part A: Patients who have received prior therapy with a PARP inhibitor, with the exception of BMN 673, are eligible; however, patients who have progressed on a PARP inhibitor and temozolomide regimen are not eligible
* Part B: Patients who have previously been exposed to a PARP inhibitor are not eligible
* For patients with solid tumors without known bone marrow involvement: peripheral absolute neutrophil count (ANC) >= 1000/mm\^3
* For patients with solid tumors without known bone marrow involvement: platelet count >= 100,000/mm\^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
* For patients with solid tumors without known bone marrow involvement: hemoglobin >= 8.0 g/dL (may receive red blood cell \[RBC\] transfusions)
* All patients enrolled on Part A of the study must be evaluable for hematologic toxicity
* Patients on Part B of the study with known bone marrow metastatic disease will be eligible for the study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity
* Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m\^2 or a maximum serum creatinine (mg/dL) based on age/gender as follows:
* 1 to < 2 years: 0.6
* 2 to < 6 years: 0.8
* 6 to < 10 years: 1
* 10 to < 13 years: 1.2
* 13 to < 16 years: 1.5 for males, 1.4 for females
* >= 16 years: 1.7 for males, 1.4 for females
* Patients on Part A and Part B: bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
* Patients on Part A and Part B: serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =< 110 U/L; for the purpose of this study, the ULN for SGPT is 45 U/L
* Patients on Part A and Part B: serum albumin >= 2 g/dL
* All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
* For patients enrolling on Part B: tissue blocks or slides must be sent; if tissue blocks or slides are unavailable, the Study Chair must be notified prior to enrollment
Exclusion Criteria:
* Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
* Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible
* Patients who are currently receiving another investigational drug are not eligible
* Patients who are currently receiving other anti-cancer agents are not eligible (except leukemia patients receiving hydroxyurea, which may be continued until 24 hours prior to start of protocol therapy); patients with acute lymphoblastic leukemia may receive intrathecal therapy
* Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial
* Patients must be able to swallow capsules whole
* Patients who have an uncontrolled infection are not eligible
* Patients who have received a prior solid organ transplantation are not eligible
* Patients with prior TBI, craniospinal XRT and/or those with >= 50% radiation of the pelvis are not eligible
* Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible
* Patients with known hypersensitivity to temozolomide or dacarbazine are not eligible
* Phase 1 (Part A): patients who have progressed on a PARP inhibitor and temozolomide regimen are not eligible
* Phase 2 (Part B): patients who have previously been exposed to a PARP inhibitor are not eligible
* Phase 1 (Part A): patients with known bone marrow involvement are not eligible | 38,094 |
Study Objectives
Implementing an evidence-based computerized decision support system linked to electronic health records to improve care for cancer patients.
The ONCO-CODES (Computerized DEcision Support in ONCOlogy) trial is a pragmatic, parallel group, randomized controlled study with 1:1 allocation ratio Study Duration 12 month Study Center(s) Single-center
Objectives:
The primary outcome of this trial is a process outcome. i.e. the rate at which the issues reported by the reminders are resolved (resolution rates).
Conditions: Medical Oncology
Intervention / Treatment:
OTHER: computer reminders on clinical practice, OTHER: Control group
| Inclusion Criteria:
* The Investigators will include all the EHRs of patients admitted to the facilities of the IRST IRCCS.
Exclusion Criteria:
* There are no exclusion criteria. | 26,187 |
Study Objectives
This trial is a retrospective, observational study, patients who underwent surgical resection of the pancreas for non-metastatic pancreatic cancer between 2016 and 2022 were selected and divided into two groups according to with (study arm) or without (control arm) nimotuzumab. The primary efficacy endpoint was overall survival (OS).
Conditions: Resectable Pancreatic Cancer
Intervention / Treatment:
DRUG: Nimotuzumab
| Inclusion Criteria:
* Age≥18 years old, gender is not limited;
* Confirmed by histopathological or cytological diagnosis of pancreatic cancer;
* Underwent surgical resection of the pancreas for non-metastatic pancreatic cancer (including resectable/borderline resectable pancreatic cancer, or locally advanced pancreatic cancer);
* Received Nimotuzumab plus adjuvant chemotherapy or adjuvant chemotherapy alone after surgery.
Exclusion Criteria:
* Patients with other primary malignancies other than pancreatic cancer;
* Evidence of recurrence or distant metastasis before surgery
* Received immunotherapy drugs (such as PD-1 inhibitors, etc.) used during adjuvant therapy, or proprietary Chinese medicines with anti-tumor indications, or hyperthermia, targeted therapy drugs other than nimotuzumab;
* Key information is missing (e.g., primary endpoint data were not available). | 9,192 |
Study Objectives
Many clinical studies have been reported on iMRI, however, their evidence levels are relatively not as good as what people hope they will be. Based on the available literature, there is, at best, level 2 evidence that iMRI-guided surgery is more effective than conventional neuronavigation-guided surgery.
The investigators aim to do a single center prospective randomized triple-blind controlled clinical trial to assess the effect of 3.0T high-field intraoperative MRI-guided glioma resection on surgical efficiency and progression-free survival of malignant glioma to provide a level 2A evidence for its clinical application.
Conditions: Glioma
Intervention / Treatment:
PROCEDURE: iMRI, PROCEDURE: conventional neuronavigation
| Inclusion Criteria:
* Individuals aged 18-70 years with highly suspected (as assessed by study surgeon), newly diagnosed, untreated malignant glioma (see appendix 1)* Individuals with supratentorial gliomas with bodies involving in frontal lobe, temporal lobe, parietal lobe, occipital lobe or insular lobe* Individuals with the preoperative assessment that radiological radicality should be achieved* Individuals either with or without tumor in eloquent areas (see appendix 2)* Karnofsky performance scale 70 or more* All patients gave written informed consent.
Appendix 1. Histological types(WHO 2007):
* Astrocytic tumours:Pilomyxoid astrocytoma 9425/3 Pleomorphic xanthoastrocytoma 9424/3 Diffuse astrocytoma 9400/3 Fibrillary astrocytoma 9420/3 Gemistocytic astrocytoma 9411/3 Protoplasmic astrocytoma 9410/3 Anaplastic astrocytoma 9401/3 Glioblastoma 9440/3 Giant cell glioblastoma 9441/3 Gliosarcoma 9442/3* Oligodendroglial tumours:Oligodendroglioma 9450/3 Anaplastic oligodendroglioma 9451/3* Oligoastrocytic tumours:Oligoastrocytoma 9382/3 Anaplastic oligoastrocytoma 9382/3* Ependymal tumours:Ependymoma 9391/3 Cellular 9391/3 Papillary 9393/3 Clear cell 9391/3 Tanycytic 9391/3 Anaplastic ependymoma 9392/3
Morphology code of the International Classification of Diseases for Oncology (ICD-O) {614A} and the Systematized Nomenclature of Medicine (http://snomen.org). Behaviour is coded /0 for benign tumours, /3 for malignant tumours and /1 for borderline or uncertain behaviour.
Tumor grade: grade II\~IV according to the latest WHO grading criteria;
Appendix 2. Tumor location in eloquent areas:
located in or close to areas of the dominant-hemisphere that associated with motor or language functions, including:
* Frontal lobe, which divided into inferior frontal gyrus (BA44-Pars opercularis, BA45-Pars triangularis/Broca's area), middle frontal gyrus (BA9, BA46), superior frontal gyrus (BA4, BA6, BA8), primary motor cortex (BA4), premotor cortex (BA6), and supplementary motor area (BA6)* Parietal lobe, which divided into inferior parietal lobule (BA40-supramarginal gyrus, BA39-angular gyrus), parietal operculum (BA43), and primary somatosensory cortex (BA1, BA2, BA3)* Temporal lobe, which divided into transverse temporal gyrus (BA41, BA42), superior temporal gyrus (BA38, BA22/Wernicke's area), middle temporal gyrus (BA21)* Insular lobe.
Exclusion Criteria:
* Individuals with age < 18 years or > 70 years* Tumours of the midline, basal ganglia, cerebellum, or brain stem* Recurrent gliomas after surgery (except needle biopsy)* Primary gliomas with history of radiotherapy or chemotherapy* Contraindications precluding intraoperative MRI-guided surgery* Inability to give informed consent* KPS < 70* Renal insufficiency or hepatic insufficiency* History of malignant tumours at any body site* Tumour locations (in important eloquent area) do not enable complete resection of tumour. | 26,273 |
Study Objectives
The purpose of this study is to determine the efficacy and the safety of PGA(Poly-gamma Glutamic Acid) for the the fertile women with Cervical Intraepithelial Neoplasia (CIN1).
Conditions: Cervical Intraepithelial Neoplasia
Intervention / Treatment:
DRUG: Poly-gamma Glutamic Acid, DRUG: Placebo
| Inclusion Criteria:
* Fertile women between age of 20 and 49
* Patients with cervical intraepithelial neoplasia 1(CIN1)
* HPV(Human Papilloma Virus) positive(+)
* White Blood Cell Count(WBC) over 4thous/ul, Hemoglobin above over 9.0g/dL Platelet over 150thous/uL and ANC(Absolute Neutrophil Count) over 1,500 10\^6/L
* AST(Aspartate Aminotransferase) no less than 4 times higher than normal ALT(Alanine Aminotransferase) no less than 4 times higher than normal
* Normal for EKG(Electrocardiography) and no active disease detected trough chest X-ray
* Be informed of the nature of the study and will give written informed consent
Exclusion Criteria:
* Malignant tumor in any organ other than cervical intraepithelial neoplasia
* Active liver disease, immune disorder and severe renal failure
* Leukemia, collagenosis, sclerosis, autoimmune disease, clinically significant allergic disease(mild allergic symptom not required medicine excluded)
* Diagnosed diabetes
* Taking any of followings affecting immunological reaction within 7 days (Glucocorticoid, vitamins, health food and oriental medicine etc)
* Pregnancy and breastfeeding
* Registered in other clinical trials
* Patients whom the investigator considers inappropriate to participate in the study | 37,168 |
Study Objectives
This study aims to develop a life review program and test its effectiveness on a sample of patients with advanced cancer patients receiving palliative care at home in Fuzhou.
Conditions: Advanced Cancer
Intervention / Treatment:
BEHAVIORAL: a life review program
| Inclusion Criteria:
* Patients who are newly admitted to the study hospice* Patients who are suffering from cancer with metastasis made by a physician* Patients who know their diagnosis, prognosis and therapy* Patients' functional performance (the score of KPS) at or more than 50%* Patients who are adults (≥18 years old)* Patients who have no cognitive and verbal communication impairments
Exclusion Criteria:
* Patients with planned treatments, such as chemotherapy, radiotherapy or surgery* Patients with psychiatric disorders* Patients who live outside Fuzhou since the following-up home visit services are not extended to those areas | 1,610 |
Study Objectives
Primarily, this clinical investigation compared the efficacy of tamoxifen + aminoglutethimide vs. tamoxifen alone in terms of prognosis (overall survival) in postmenopausal patients with potentially curative, operated hormone receptor-positive breast cancer.
Conditions: Early-stage Breast Cancer
Intervention / Treatment:
DRUG: Tamoxifen alone, DRUG: Tamoxifen + Aminoglutethimide
| Inclusion Criteria:
* Postmenopausal patients with histologically verified, locoradically treated, invasive or minimally invasive breast cancer
* Hormone receptor-positive status
* More than 6 histologically examined lymph nodes
* Laboratory parameters
1. hematopoiesis: > 3500/µl leucocytes, > 100,000/µl thrombocytes
2. renal function: creatinin < 1.5mg%
3. hepatic function: GOT < 2.5 x UNL
4. bilirubin: < 1.5mg %
5. metabolic parameters: Na, Ca, K in normal range, normal level of blood sugar
* Concluded healing process following surgery
* Less than 4 weeks interval since surgery
* Informed consent
Exclusion Criteria:
* Premenopausal patients, non-determinable menopausal status
* Previous radiotherapy, chemotherapy or endocrine treatment
* Generalized disease (as verified by lung X-ray, skeletal X-ray, liver ultrasound)
* Contraindications against tamoxifen or anastrozole
* T4 tumors; carcinoma in situ
* Lacking compliance or understanding of disease
* Karnofsky Index < 3
* Serious concomitant disease
* Septic complications, systemic infections or infectious local processes
* Bilateral ovariectomy or ovarian irradiation
* Second carcinoma or status post second carcinoma (except for treated squamous cell carcinoma of the skin or cervical carcinoma in situ) | 222 |
Study Objectives
Urothelial carcinoma is the ninth most common malignant neoplasm worldwide. nearly in all human tumors, actin filaments are involved in lamellopodia or cellular extensions. Cortactin is involved in fixing the actin assembly to enhance cellular penetration. Assessment of Cortactin expression in invasive and non-invasive urothelial carcinoma and recording any significant different expressions may have benefits in developing more effective anticancer chemotherapeutic agents.
Conditions: Urothelial Carcinoma
Intervention / Treatment:
GENETIC: Expression of Cortactin anti body
| Inclusion Criteria:
* patients with primary urinary bladder carcinoma.
Exclusion Criteria:
* patients received chemotherapeutic agents. | 14,188 |
Study Objectives
Participants will be recruited from the community and attend a screening clinic and undergo the following screening tests:
1. Bi-parametric MRI - reported by a radiologist and CAD-AI system
2. Multiparametric ultrasound - including shearwave elastography
3. A standard-of-care PSA test
A systematic +/- targeted biopsy will be performed if any tests are positive, independent of the other tests.
Conditions: Prostate Neoplasm
Intervention / Treatment:
| Inclusion Criteria:
* Men aged between 50 and 69 years inclusive at the time of study entry* Participants must be fit to undergo all procedures listed in the protocol* Estimated life expectancy of 10 years or more* An understanding of the English language sufficient to understand written and verbal information about the trial and consent process* Participants must be willing and able to provide written informed consent
Exclusion Criteria:
* Previous PSA test or prostate MRI within the prior two years of screening/consent visit* Evidence of a urinary tract infection or history of acute prostatitis within the last 6 months* Previous history of prostate cancer, prostate biopsy or treatment for prostate cancer* Any potential contraindication to MRI* Any potential contraindication to prostate biopsy* Dementia or altered mental status that would prohibit the understanding or rendering of informed consent.* Any other medical condition precluding procedures described in the protocol | 14,044 |
Study Objectives
The goal of this study is to validate the new ExAblate Application software V4.2 by developing additional data that shows the safety of this treatment. The ExAblate is intended to ablate uterine fibroid tissue in pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have a uterine size of less than 24 weeks and not seeking treatment for reasons of improving fertility.
Conditions: Uterine Fibroids, Uterine Leiomyomas
Intervention / Treatment:
DEVICE: ExAblate 2000
| Inclusion Criteria:
* Women who present with symptomatic uterine fibroids and are not seeking treatment for the reason of improving fertility.* Able and willing to give consent and able to attend all study visits.* Patient is pre or peri-menopausal (within 12 months of last menstrual period).* Able to communicate sensations during the ExAblate procedure.* Uterine fibroids, which are device accessible (i.e., positioned in the uterus such that they can be accessed without being shielded by bowel or bone).* Fibroids(s) clearly visible on non-contrast MRI.
Exclusion Criteria:
* Metallic implants that are incompatible with MRI* Sensitive to MRI contrast agents* Severe claustrophobia that would prevent completion of procedure in MR unit* Who are pregnant or desire to become pregnant in the future. Pregnancies following ExAblate treatment could be dangerous for both mother and fetus.* Pedunculated fibroids* Active pelvic inflammatory disease (PID)* Active local or systemic infection* Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia* Intrauterine device (IUD) anywhere in the treatment path* Dermoid cyst of the ovary anywhere in the treatment path* Extensive abdominal scarring that cannot be avoided by redirection of the beam (e.g., due to Caesarean section or repeated abdominal surgeries)* Undiagnosed vaginal bleeding | 27,948 |
Study Objectives
We will conduct a trial to determine whether paclitaxel/cisplatin (TP) as an adjuvant chemotherapy after radical surgery improve disease-free survival (DFS) and overall survival (OS), as well as the quality of life (QoL) among early-stage (FIGO stage IB-IIA) cervical cancer patients with risk factors.
Conditions: Uterine Cervical Neoplasms, Cervical Cancer, Uterine Cervical Cancer
Intervention / Treatment:
PROCEDURE: radical hysterectomy + pelvic lymph node dissection, DRUG: Paclitaxel, DRUG: Cisplatin, DRUG: Cisplatin, RADIATION: Pelvic RT
| Inclusion Criteria:
* FIGO stage: ⅠB~ⅡA, cervical cancer;
* Age≤60 years; female, Chinese women;
* Initial treatment is radical hysterectomy + pelvic lymph node dissection;
* Pathological diagnosis: cervical squamous cell invasive carcinoma;
* Pathologic examination and meet the following one of the indications of adjuvant therapy: ① lymph node metastasis, ② parametrial invasion, ③ ≥ 2/3 deep stromal invasion, ④ histopathological grading in poorly differentiated (G2 to G3), ⑤ lymphatic vascular space involvement, ⑥ tumor diameter> 4cm;
* Laboratory tests: WBC≥4×10(9)/L, NEU≥2×10(9)/L, PLT≥80×10(9)/L, serum bilirubin≤ 1.5 times the upper limit of normal, transaminase≤ 1.5 times the upper limit of normal, BUN, Cr≤ normal
* Performance status: Karnofsky score≥60;
* No prior treatment;
* Receiving extensive resection of uterus (type III) plus pelvic lymph nodes wide resection; pathologically diagnosed with cervical squamous cell carcinoma;
* Provide written informed consent.
Exclusion Criteria:
* With severe or uncontrolled internal disease, unable to receive surgery and/or unsuitable for radiotherapy or chemotherapy
* History of organ transplantation, immune diseases;
* History of serious mental illness, a history of brain dysfunction;
* Drug abuse or a history of drug abuse;
* Suffering from other malignancies;
* Concurrently participating in other clinical trials
* Unable or unwilling to sign informed consents;
* Unable or unwilling to abide by protocol. | 32,509 |
Study Objectives
For cancer cells to grow, they need to have nutrients supplied to them through blood vessels. The study drug, ACE-041, is designed to work by blocking the growth of those blood vessels and preventing cancer cells from growing. The purpose of this study is to establish safe dose levels of ACE-041 in patients with advanced solid tumors or relapsed/refractory multiple myeloma following multiple dose administration. This study will also evaluate if ACE-041 has an effect on tumors.
Conditions: Advanced Solid Tumors, Multiple Myeloma
Intervention / Treatment:
BIOLOGICAL: ACE-041
| Inclusion Criteria:
* Diagnosis of metastatic or unresectable advanced solid tumors (solid tumors must be measurable) or relapsed/refractory multiple myeloma for which the disease has progressed despite available standard therapies or for which no standard therapy exists.
* Life expectancy of at least 12 weeks.
* Eastern Cooperative Oncology Group (ECOG) Performance status of 0, 1, or 2 (not declining within 2 weeks prior to study day 1).
Exclusion Criteria:
* Central nervous system (CNS) metastases.
* Chemotherapy or other anti-cancer therapy within 4 weeks prior to study day 1, and/or nitrosoureas within the 6 weeks prior to study day 1.
* Lack of recovery from all toxic effects of previous chemotherapy, radiation therapy, biologic therapy, and/or experimental therapy with the exception of alopecia.
* Radiation therapy within 4 weeks prior to study day 1.
* Clinically significant pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal or genitourinary disease unrelated to underlying solid tumor or multiple myeloma
* Significant cardiac risk (e.g. history of myocardial infarction, unstable angina, pulmonary hypertension, clinically significant arrhythmia, congestive heart failure within 1 year prior to study day 1).
* Diagnosis or family history of hereditary hemorrhagic telangiectasia.
* Major surgery within 6 weeks prior to study day 1.
* Parenteral antibiotics, or any life-threatening or active infection requiring parenteral antibiotic therapy within 1 month prior to study day 1.
* Therapeutic anti-coagulation.
* Uncontrolled hypertension.
* Autoimmune or hereditary hemolysis.
* Clinically significant gastrointestinal bleeding or any other clinically significant active bleeding within 3 months prior to study day 1.
* Treatment with another investigational drug or device, or approved therapy for investigational use within 28 days prior to study day 1.
* Pregnancy or lactation for female patients. | 26,193 |
Study Objectives
The investigators will conduct nationally representative survey in chest physicians in Egypt in 2016-2017. Self-administered questionnaire will be used to assess the physicians' knowledge of lung cancer screening guidelines, beliefs about the effectiveness of screening tests, and ordering of screening chest radiography, low-dose spiral computed tomography, or sputum cytology in the past 12 months.
Conditions: Lung Cancer Screening
Intervention / Treatment:
OTHER: Audit
| Inclusion Criteria:
* Physicians practising in Egypt (Chest physicians, general practitioners, and general internists)
Exclusion Criteria:
* Other nationalities
* Other specialities | 4,989 |
Study Objectives
The objective of this protocol is to provide SU011248 treatment for patients who have participated in a SU011248 protocol and are eligible to enter this protocol
Conditions: Solid Tumors
Intervention / Treatment:
DRUG: Sunitinib
| Inclusion Criteria:
* Prior SU011248 Protocol.
* Eligible to continue SU011248 treatment.
Exclusion Criteria:
* Uncontrolled CNS metastasis.
* Unfit to receive SU011248. | 1,808 |
Study Objectives
This study is a multi-center, open-label, dose escalation and expansion study of RLY-1971 in subjects with advanced or metastatic solid tumors.
Conditions: Solid Tumor, Unspecified, Adult
Intervention / Treatment:
DRUG: RLY-1971
| Inclusion Criteria:
Subject is willing and able to provide written informed consent for the study prior to the performance of any study-specific procedures Subject is a male or female subject ≥18 years of age at the time of consent Subject must have an ECOG PS ≤ 1 Subject must have histologically or cytologically confirmed advanced or metastatic solid tumor Subjects who are refractory to FDA-approved, standard therapy or for which standard or curative therapy does not exist or is not considered sufficient or appropriate by the patient or Investigator Subject must have radiographically measurable or evaluable disease Subject must have recovered from the reversible effects of prior anti-neoplastic therapy, except for alopecia and ≤ grade 2 neuropathy.
Subject has adequate end organ function Subject is willing to comply with all protocol-required visits, assessments, and procedures Male and female subjects of child-bearing potential are willing to use medically acceptable methods of birth control from the screening visit through 30 days after the last dose of study medication
Exclusion Criteria:
Subjects with documented history of tumor mutations that may not be amenable to treatment with RLY-1971, including:
KRAS mutations: G12D, G12V, G13X, and Q61X BRAF V600E mutation MEK mutations Subjects with prior antineoplastic therapy within 3 weeks of Study Day 1, or 5 half-lives, whichever is shorter Subjects with prior palliative radiotherapy within 1 week of Study Day 1 Subjects who have had major surgery or trauma, or incomplete recovery from surgery or trauma, within 4 weeks of Study Day 1 Subjects with known central nervous system (CNS) metastases or primary CNS tumor that is associated with progressive neurologic symptoms or requires increasing doses of corticosteroids to control the CNS disease. If patient requires corticosteroids for management of CNS disease, the dose must have been stable for the 2 weeks preceding C1D1, or subject has new lesions appearing on follow up brain MRI that require CNS-directed intervention.
Subjects with a history or evidence of ophthalmic disease Subjects with a history or evidence of significant cardiac dysfunction Subjects with a history or evidence of significant gastrointestinal disease Subjects with other serious concurrent medical conditions Subject is pregnant, as documented by a serum beta human chorionic gonadotropin (β-hCG) pregnancy test consistent with pregnancy obtained within 7 days before the first dose of study treatment | 14,229 |
Study Objectives
This is an observational study in which data from people with cancer who had the Coronavirus disease 2019 (COVID-19) are collected and studied. In observational studies, only observations are made without specified advice or interventions.
The most recently discovered coronavirus (SARS-CoV-2) may cause illness in humans ranging from the common cold to serious illness, also known as COVID-19.
People with cancer are particularly at risk of becoming very sick with COVID-19, especially during or shortly after a cancer treatment. Several treatments for COVID-19 have been tested in clinical studies. However, people with cancer or with recent cancer treatments were usually excluded.
Tyrosine kinase inhibitors (TKIs) are used to treat several cancer types. TKIs including regorafenib and sorafenib block certain proteins, which are involved in the growth of cancer. They also have an anti-inflammatory effect and may be able to block the entry of the coronavirus into the cell. This could possibly prevent infection. However, data on COVID-19 from people with cancer receiving TKIs are missing.
The main purpose of this study is to find out whether COVID-19 outcomes were different in people with cancer receiving TKIs compared to those receiving other anti-cancer drugs. To do this, researchers will compare COVID-19 outcomes within 30 days of COVID-19 diagnosis between both groups.
The data for the comparison will come from databases called Optum and MarketScan.
Besides this data collection, no further tests or examinations are planned in this study.
There are no required visits or tests in this study. Data will be from October 2019 to June 2021 or the latest available data.
Conditions: Malignant Solid Tumors, Coronavirus Disease 2019 (COVID-19), SARS-CoV-2 Infection
Intervention / Treatment:
DRUG: Non-TKIs, DRUG: Other TKIs, DRUG: Regorafenib (Stivarga, BAY73- 4506), DRUG: Sorafenib (Nexavar, BAY43-9006)
| Inclusion Criteria:
TKIs Treated Group
* Patients ≥18 years old at index date
* Patients who had any healthcare encounter with a primary or secondary diagnosis of Coronavirus disease 2019 (COVID-19) or positive results from Polymerase Chain Reaction (PCR) lab test for Severe acute respiratory syndrome coronavirus 2 (SARs-CoV-2) during the patient identification period (January 1, 2020 to May 31, 2021 or one month before the latest data cut)
* Patient who was under TKIs on index date or the last episode of TKIs treatment ended within 30 days before index date
* Patient who had any diagnosis of solid tumors at any time before index date (identified using ICD-9 or ICD-10 diagnosis codes, Supplementary Table 5)
* Continuous insurance enrollment for at least 90 days before index date
Non-TKIs Treated Group
* Patients ≥18 years old at index date
* Patients who had any healthcare encounter with a primary or secondary diagnosis of COVID-19 or positive results from PCR lab test for SARs-CoV-2 during the patient identification period
* Patient who had any diagnosis of solid tumors any time before the index
* Patient who was under anti-neoplastic medications on index date or the last episode of the anti-neoplastic treatment ended within 30 days before index date
* Continuous insurance enrollment for at least 90 days before index date
Exclusion Criteria:
TKIs treated Group
* Patients who had secondary cancer without site specification (only had ICD-10 codes C79.9 or C80 for metastasis) from 90 days before index
Non-TKIs Treated Group
* Patients who had any claims of TKIs treatment during the study period
* Patients who had secondary cancer without site specification (only had ICD-10 codes C79.9 or C80 for metastasis) from 90 days before index | 36,822 |
Study Objectives
This study was conducted in 2 serial phases (dosimetry phase and effectiveness phase) to evaluate a balloon-based ablation device (HALO360) that delivers a pre-set amount of energy density (J/cm2) to barrett's tissue. The dosimetry phase evaluated the dose-response and the safety of delivering 6 to 12 J/cm2. The effectiveness phase used 10 J/cm2 delivered twice for all patients, followed by Esophagogastroduodenoscopy (EGD) with biopsies at 1, 3, 6, and 12 months. A second ablation procedure was performed if Barretts esophagus (BE) was present at 1 or 3 months. A complete response (CR) was defined as all biopsy specimens negative for Barrett's Esophagus at 12 months. The effectiveness phase of the present study was extended to a 2.5-year follow-up. This trial incorporated an opportunity for persistent BE to be treated with a focal ablation device (HALO90), achieving a CR in 98.4% of patients by the 2.5-year follow-up,the results of which were published . There is ample evidence that RadioFrequency Ablation (RFA) for Barrett's esophagus is effective and safe. Having additional follow-up (5 years) would add valuable information to the literature, thus aiding the physician in making patient management decisions about the appropriate follow-up interval after RFA.
Conditions: Barrett Esophagus
Intervention / Treatment:
DEVICE: HALO Ablation System
| Inclusion Criteria:
* Subject has documented histopathological diagnosis of Barrett's metaplasia (without dysplasia) as follows:
* biopsies obtained less than 6 months prior to enrollment, and
* biopsies obtained and reviewed at the investigator institution, and
* biopsy protocol included at least 4 quadrant biopsies per 2 cm length of Barrett's metaplasia* Barrett metaplasia endoscopic length:
Phase I : 2-3 cm Barrett's length (inclusive) Phase II: 2-6 cm Barrett's length (inclusive)* Age 18-75 years inclusive* Subject agrees to participate, fully understands content of informed consent form, and signs the informed consent form* Five year extension: All subjects who participated in B-200-2.5 year extension and had a biopsy at 2.5 years after initial enrollment (n=61) will be offered participation in this extension.
Exclusion Criteria:
* Subjects is pregnant or planning a pregnancy* Esophageal stricture preventing passage of endoscope or catheter* Active esophagitis (Hetzel-Dent Grade III or IV) described as erosions or ulcerations encompassing more than 10% of distal esophagus* Barrett's metaplasia with dysplasia (any previous biopsy)* History or current diagnosis of malignancy of the esophagus* Prior radiation therapy to the esophagus, except head and neck region radiation therapy* Any previous ablative therapy within the esophagus (photodynamic therapy, multipolar electrical coagulation, argon plasma coagulation, laser treatment, or other)* Any previous endoscopic mucosal resection within the esophagus* Any previous esophageal surgery, except fundoplication* Esophageal varices* Subject has an implantable pacing device (examples; AICD, neurostimulator, cardiac pacemaker) and has not received clearance for enrollment in this study by specialist responsible for the pacing device* Participation in another clinical study in past 60 days* Subject suffers from unstable psychiatric disorder(s) | 12,234 |
Study Objectives
The purpose of this study is to test the safety of the combination of two drugs called RAD001 and AMG479. This study will see what effects (good and bad) RAD001 and AMG479 have on cancer. This study will also find the highest doses of RAD001 and AMG479 that can be given without causing severe side effects.
Conditions: Neoplasm Metastases
Intervention / Treatment:
DRUG: RAD001 + AMG479
| Inclusion Criteria:
* Histological or cytological proof of metastatic solid tumor refractory to standard therapies, or for which no standard therapies are available.
* Patients in the expansion cohort must have a measurable site of disease according to RECIST (v 1.0)
* Laboratory values must be obtained within protocol limits and obtained within 14 days prior to registration
* Patients must have disease which is not amenable to potentially curative surgical resection of metastatic disease (curative metastasectomy).
* Must be willing to provide metastatic tissue biopsy samples (may be paraffin embedded) at baseline
* Must be willing to undergo a metastatic tissue biopsy after 2 cycles of therapy to perform pharmacodynamic research biomarkers testing.
* Subjects must be willing and able to abstain from using strong or moderate CYP3A4 inhibitors or inducers during the study period.
Exclusion Criteria:
* No symptomatic brain metastasis
* No prior treatment with an mTOR inhibitor or with an IGF-1R inhibitor
* No known history of diabetes mellitus
* No thrombosis or vascular ischemic events within the last twelve months
* No chronic treatment with systemic steroids or another immunosuppressive agent
* No active bleeding or a pathological condition that is associated with a high risk of bleeding
* No known history of HIV seropositivity
* No known history of Hepatitis B or Hepatitis C seropositivity
* No known hypersensitivity to AMG 479, RAD001 (everolimus), other rapamycins (sirolimus, temsirolimus), or to its excipients
* No planned immunization with attenuated live viruses during the study period | 29,057 |
Study Objectives
The objective of this study is to characterize and compare the risks of long-term use of oral contraceptives containing drospirenone and of other established oral contraceptives.
Conditions: Arterial Thromboembolism, Venous Thromboembolism, Breast Cancer
Intervention / Treatment:
| Inclusion Criteria:
* Women who are prescribed an oral contraceptive and who are new users (first-ever users, switchers or restarters) of the formulation
Exclusion Criteria:
* Women who do not consent to participate in the study | 17,386 |
Study Objectives
Phase II trial to study the effectiveness of bortezomib in treating patients who have low-grade lymphoproliferative disorders. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.
Conditions: Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma
Intervention / Treatment:
DRUG: bortezomib
| Inclusion Criteria:
* Histologically or cytologically confirmed lymphoproliferative disorder of 1 of the following subtypes:
* \* Relapsed or refractory grade I, II, or III follicular center cell lymphoma
* Relapsed or refractory mantle cell lymphoma
* Measurable disease for non-Hodgkin's lymphoma (NHL) only
* At least 1 unidimensionally measurable lesion
* At least 2 cm by conventional techniques OR at least 1 cm by spiral CT scan
* Lymph nodes no greater than 1 cm in short axis considered normal
* Absolute lymphocytosis greater than 5,000/mm\^3 with B-cell phenotype (CD19, 20,or 23 positive) with more than 30% bone marrow lymphocytes for CLL or other leukemic forms of NHL
* No known brain metastases
* Performance status - Karnofsky 70-100%
* At least 3 months
* See Disease Characteristics
* Absolute neutrophil count greater than 1,500/mm\^3 (500/mm\^3 if lymphomatous involvement of bone marrow)
* Platelet count greater than 50,000/mm\^3
* Bilirubin less than 1.5 times upper limit of normal (ULN)
* AST and ALT no greater than 2.5 times ULN (4 times ULN in case of liver metastases)
* Creatinine less than 1.5 times ULN
* No symptomatic congestive heart failure
* No New York Heart Association class III or IV heart disease
* No unstable angina pectoris
* No cardiac arrhythmia
* No myocardial infarction within the past 6 months
* No cerebrovascular accident or transient ischemic attack within the past 6 months
* No history of orthostatic hypotension
* No evidence of acute ischemia or significant conduction abnormality (left anterior hemiblock in the presence of right bundle branch block or second or third degree atrioventricular blocks) on electrocardiogram
* No uncontrolled hypertension requiring antihypertensive medication
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Febrile episodes up to 38.5°C allowed if no evidence of active infection
* No other uncontrolled concurrent illness
* No known or active HIV infection
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study entry
* At least 3 months since prior monoclonal antibody therapy (e.g., rituximab)
* No more than 3 prior regimens of conventional cytotoxic chemotherapy
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
* At least 1 week since prior steroid therapy
* At least 4 weeks since prior radiotherapy and recovered
* At least 4 weeks since prior major surgery
* No other concurrent investigational agents | 8,013 |
Study Objectives
This is a study to investigate the efficacy and safety of epirubicin, cisplatin and capecitabine (ECX) as neoadjuvant therapy prior to radical chemoradiotherapy using capecitabine and cisplatin as radio-sensitisers in patients with newly diagnosed localized squamous cell carcinoma of the oesophagus.
Conditions: Oesophageal Carcinoma
Intervention / Treatment:
DRUG: Epirubicin, Cisplatin, Capecitabine, PROCEDURE: Surgical Resection
| Inclusion Criteria:
* Age > 18 years.
* Histologically verified squamous cell carcinoma of the cervical or thoracic oesophagus
* American Joint Committee on Cancer (AJCC) Stage I-III (T1-3 N0-1 M0) (33), as assessed by spiral or multi-slice computed tomography (CT) and endoscopic ultrasound, where radical chemoradiation would be considered with curative intent.
* No previous chemotherapy, radiotherapy or other investigational drug treatment for this indication.
* World Health Organization (WHO) performance status 0,1 or 2.
* Adequate bone marrow function with platelets > 100 x 10\^9/l; white blood cells (WBC) > 3 x 10\^9/l; neutrophils > 1.5 x 10\^9/l at the time of study entry.
* Serum bilirubin < 35 micromol/l.
* Serum creatinine < 180 micromol/l and measured creatinine clearance over 60 ml/min.
* No concurrent uncontrolled medical condition.
* No previous malignant disease other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix in the last 10 years.
* Life expectancy > 3 months.
* Adequate contraceptive precautions if relevant.
* Informed written consent.
Exclusion Criteria:
* The presence of locally advanced or metastatic disease precluding curative chemoradiation (T4 or Stage IV or M1a-b) or disease not encompassable in a radical radiotherapy field.
* Total dysphagia (O'Rourke's swallowing function scoring system 5) precluding swallowing of capecitabine even when crushed.
* Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
* Intracerebral metastases or meningeal carcinomatosis.
* New York Heart Association classification Grade III or IV.
* Uncontrolled angina pectoris.
* Pregnancy or breast feeding.
* Impaired renal function with measured creatinine clearance less than 60 ml/min.
* Previous investigational study drug
* Known malabsorption syndromes
* Patients with a known hypersensitivity to fluorouracil (5-FU) or with a dihydropyrimidine dehydrogenase (DPD) deficiency
* Hearing loss | 397 |
Study Objectives
This study is designed to examine the impact of telephone-based colorectal cancer risk assessment on colorectal screening attitudes and behavior among previously unscreened adults ages 50 to 75.
Conditions: Colorectal Cancer
Intervention / Treatment:
BEHAVIORAL: Risk Assessment (CCRAT), BEHAVIORAL: Usual Care (UC)
| Inclusion Criteria:
* Patient of any participating physician
* Not having had any colorectal cancer screening test prior
* Able to speak English
Exclusion Criteria:
* Personal history of inflammatory bowel disease
* Personal history of colorectal cancer
* Personal history of Lynch syndrome or Familial Adenomatous Polyposis
* Have already received colorectal cancer screening | 18,530 |
Study Objectives
The primary purpose of this study is to evaluate the clinical response and safety of CMAB009 plus irinotecan versus irinotecan-only as second-line treatment after fluoropyrimidine and oxaliplatin failure in KRAS wild-type metastatic colorectal cancer patients
Conditions: Metastatic Colorectal Cancer
Intervention / Treatment:
DRUG: CMAB009 plus Irinotecan, DRUG: Irinotecan-only and sequential-CMAB009
| Inclusion Criteria:
* histologically confirmed metastatic colorectal adenocarcinoma
* KRAS wild-type tumors, EGFR-expressing or EGFR-nonexpressing by immunohistochemistry;
* has measurable lesion, at least 1cm in diametre by CT or MRI, at least 2cm diametre by physical examination or other iconography
* ECOG performance status 0 to 1
* Failure (disease progression/discontinuation due to toxicity) of fluoropyrimidine and oxaliplatin treatment,stop at least one month thereafter, irinotecan-naïve
Exclusion Criteria:
* Previous irinotecan or anti-EGFR therapies
* hematologic function: hemoglobin, less than 90g per liter; neutrophil count, less than 1500 per cubic millimeter; and platelet count, less than 100,000 per cubic millimeter
* liver function: bilirubin, more than 1.0 times the upper limit of normal; aspartate aminotransferase and alanine aminotransferase, more than 5.0 times and 2.5 times the upper limit of normal with hepatic metastasis or not
* Renal function: serum creatinine, more than 1.5 times the upper limit of normal
* Patients with symptomatic central nervous system metastases | 10,423 |