EUCTR2019-001364-30-FR进行中（未招募）1 期
Randomized phase 3 trial comparing FOLFOX to gemcitabine in metastatic first-line in patients with pancreatic adenocarcinoma and non-fit for FOLFIRINOX - GEMFOX
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1.Signed and dated informed consent, and willing and able to comply with protocol requirements,
- •2.Histologically or cytologically proven adenocarcinoma of the pancreas,
- •3.In absence of histologically or cytologically proven adenocarcinoma, a cluster of clinical, biological and radiological arguments consistent with the diagnosis: among these, a hypodense pancreatic tumor at CT and a Ca 19-9 greater than 500 UI/ml are essential prerequisites,
- •4.Metastatic disease confirmed (stage IV),
- •5.No prior therapy for metastatic disease (in case of previous adjuvant therapy, interval from end of chemotherapy and relapse must be >12 months),
- •6.Age =18 years,
- •7.Patient non-fit for FOLFIRINOX, with ECOG performance status (PS) 0-2
- •8.For patients with ECOG performance status (PS) = 2, an albuminemia level >25 g/l is required. An albumin infusion is not permitted before the inclusion test,
- •9.Haematological status: neutrophils (ANC) >1.5x109/L; platelets >100x109/L; haemoglobin =9g/dL,
- •10.Adequate renal function: serum creatinine level <150µM,
- •11.Adequate liver function: AST (SGOT) and ALT (SGPT) =2.5xULN (=5xULN in case of liver metastases),
- •12.Total bilirubin =3 x ULN,
- •13.Baseline evaluations performed before randomization: clinical and blood evaluations no more than 2 weeks (14 days) prior to randomization, tumor assessment (CT-scan or MRI, evaluation of non-measurable lesions) no more than 3 weeks (21 days) prior to randomization,
- •14.Female patients must be surgically sterile, or be postmenopausal, or must commit to using reliable and appropriate methods of contraception during the study and during at least six months after the end of study treatment (when applicable). All female patients with reproductive potential must have a negative pregnancy test (ß HCG) within 7 days prior to starting protocol treatment. Breastfeeding is not allowed.
- •15.Male patients must agree to use effective contraception in addition to having their partner use a contraceptive method as well during the trial and during at least six months after the end of the study treatment,
- •16.Affiliation to a French social security system (recipient or assign).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.History or evidence upon physical examination of CNS metastasis unless adequately treated (e.g. non irradiated CNS metastasis, seizure not controlled with standard medical therapy),
- •2.Local or locally advanced disease (stage I to III),
- •3.Patient uses warfarin,
- •4.Patient receiving concomitant radiotherapy,
- •5.Uncontrolled hypercalcemia,
- •6.Pre-existing permanent neuropathy (NCI grade =2),
- •7.Poor nutritional status
- •8.Known dihydropyrimidine dehydrogenase (DPD) deficiency,
- •9.Concomitant unplanned antitumor therapy (e.g. chemotherapy, molecular targeted therapy, immunotherapy),
- •10.Treatment with any other investigational medicinal product within 28 days prior to study entry,
- •11.Other serious and uncontrolled non-malignant disease (eg. active infection requiring systemic therapy, coronary stenting or myocardial infarction or stroke in the past 6 months),
- •12.Known or historical active infection with HIV, or known active infection untreated with hepatitis B or hepatitis C,
- •13.Known uncontrolled bacterial infection
- •14.History or active interstitial lung disease (ILD),
- •15.Other concomitant or previous malignancy, except: i/ adequately treated in-situ carcinoma of the uterine cervix, ii/ basal or squamous cell carcinoma of the skin, iii/ cancer in complete remission for >5 years,
- •16.Patients with known allergy to active substance or any excipient of study drugs,
- •17.Allergy to iodinated contrast product
- •18.Concomitant administration of live, attenuated virus vaccine such as yellow fever vaccine and concomitant administration of prophylactic phenytoin
- •19.Patients under legal protection or unable to consent
- •20.Participation in another interventional research
研究者
相似试验
进行中（未招募）
不适用
Randomized, Phase 2 Study of FOLFOX or FOLFIRI with AG-013736 or Bevacizumab in Patients with Metastatic Colorectal Cancer after Failure of an Irinotecan or Oxaliplatin-containing First-line RegimeSecond line treatment of patients with metastatic carcinoma of colon and rectumMedDRA version: 9.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancerMedDRA version: 9.1Level: PTClassification code 10052358Term: Colorectal cancer metastaticEUCTR2007-006283-30-CZPfizer Inc, 235 East 42nd Street, New York, NY 10017, USA176
进行中（未招募）
不适用
Randomized, Phase 2 Study of FOLFOX or FOLFIRI with AG-013736 or Bevacizumab in Patients with Metastatic Colorectal Cancer after Failure of an Irinotecan or Oxaliplatin-containing First-line RegimeSecond line treatment of patients with metastatic carcinoma of colon and rectumMedDRA version: 9.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancerMedDRA version: 9.1Level: PTClassification code 10052358Term: Colorectal cancer metastaticEUCTR2007-006283-30-BEPfizer Inc, 235 East 42nd Street, New York, NY 10017, USA176
进行中（未招募）
1 期
Randomized, Phase 2 Study of FOLFOX or FOLFIRI with AG-013736 or Bevacizumab in Patients with Metastatic Colorectal Cancer after Failure of an Irinotecan or Oxaliplatin-containing First-line RegimeSecond line treatment of patients with metastatic carcinoma of colon and rectumMedDRA version: 9.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancerMedDRA version: 9.1Level: PTClassification code 10052358Term: Colorectal cancer metastaticEUCTR2007-006283-30-FRPfizer Inc, 235 East 42nd Street, New York, NY 10017, USA176
已完成
3 期
Randomized phase III study of FOLFOX plus bevacizumab versus FOLFIRI plus bevacizumab for metastatic colorectal cancermetastatic colorectal cancerJPRN-UMIN000001396West Japan Oncology Group400
尚未招募
2 期
Evaluation of preferred chemotherapy regimen during esophageal cancer radiotherapyesophageal cancer.Malignant neoplasm of esophagusIRCT20240701062297N1Tehran University of Medical Sciences98