EUCTR2016-002393-12-BE招募中1 期
Systemic oxaliplatin or in intra-arterial chemotherapy combined with LV5FU2 ± Irinotecan, and targeted therapy, in first-line treatment of metastatic colorectal cancer restricted to the liver
Fédération Francophone de Cancérologie Digestive0 个研究点目标入组 348 人开始时间: 2020年7月22日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 348
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •-Histologically proven colorectal adenocarcinoma with hepatic metastasis(es)
- •-At least one measurable hepatic metastasis according to the criteria RECIST v1.1
- •-No other metastatic sites except lung nodules accepted if number = 3 and < 10 mm
- •-RAS mutation status known (determination of KRAS mutation [exons 2,3 and 4]and NRAS [exons 2,3 and 4])
- •-Age = 18
- •-No prior chemotherapy except perioperative or adjuvant chemotherapy discontinued for more than 12 months and the 1st course of FOLFOX or mFOLFIRINOX IV without targeted therapy before randomisation (protocolar treatment)
- •-Life expectancy > 3 months
- •-PNN > 1500/mm3, platelets > 100 000/mm3, Hb > 9 g/dLq
- •-Total bilirubin < 25 µmol/L, AST < 5x UNL, ALT < 5 x UNL, x UNL, ALP < 5 x UNL, PT > 60%, proteinuria from 24H < 1 g
- •-Creatinine clearance > 50 mL/min according to MDRD formula
- •-Patient affiliated to a social security scheme
- •-Patient information and signature of the informed consent
- •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 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 228
排除标准
- •-Contraindications specific to the installation of a KTHIA: thrombosis of the hepatic artery, arterial vascular anatomy may compromise a secondary hepatic resection.
- •-Patient immediately eligible for a curative therapy (surgical and/or percutaneous) after discussion in CPR
- •-Following alterations in the 6 months prior to inclusion: myocardial infarction, angina, severe/unstable angina, coronary artery bypass surgery, congestive heart failure NYHA class II, III or IV, stroke or transient ischemic attack
- •-Hypertension not controlled by medical treatment (SBP> 140 mmHg and/or DBP> 90 mmHg with blood pressure taken according to the diagram of the HAS)
- •-A history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess or active gastrointestinal bleeding in the 6 months preceding the start of treatment
- •-Progressive gastroduodenal ulcer, wound or fractured bone
- •-Abdominal or major extra-abdominal surgery (except diagnostic biopsy) or irradiation in the 4 weeks before starting the treatment
- •-Transplant patients, HIV positive or other immune deficiency syndromes
- •-Any progressive pathology not balanced over the past 6 months: hepatic failure, renal failure, respiratory failure
- •-Peripheral neuropathy > 1 (NCI CT v4.0)
- •-Patient with interstitial pneumonitis or pulmonary fibrosis
- •-History of chronic diarrhea or inflammatory disease of the intestine, colon or rectum, or unresolved occlusion or sub-occlusion in symptomatic treatment
- •-History of malignant pathologies during the past 5 years except basocellular skin carcinoma or in situ cervical carcinoma, properly treated
- •-Patient already included in another clinical trial with an experimental molecule
- •-Any known specific contraindication or allergy to the treatments used in the study (cf RCP Appendix 7)
- •-Partial or complete DPD deficiency (Uracilemia = 16 ng/ml)
- •-QT/QTc range > 450 msec for men and > 470 msec for women
- •-K+ < LNL, Mg2+ < LNL, Ca2+ < LNL
- •-Lack of effective contraception in patients (men and/or women) of childbearing age, pregnant or breastfeeding women, women of childbearing age not having had a pregnancy test
- •-Persons deprived of liberty or under supervision
- •-Impossibility of undergoing medical monitoring during the trial for geographic, social or psychological reasons
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