A Phase III, Randomised, International Trial Comparing mFOLFIRINOX Triplet Chemotherapy to mFOLFOX for High-risk Stage III Colon Cancer in Adjuvant Setting
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UNICANCER
- 入组人数
- 792
- 试验地点
- 17
- 主要终点
- Disease Free Survival (DFS)
研究概览
简要总结
The trial is a phase III, multicenter, open-labeled randomized trial comparing the association of 5-fluorouracil (5-FU), folinic acid, irinotecan, and oxaliplatin (mFOLFIRINOX) versus oxaliplatin, folinic acid, and 5-FU (mFOLFOX 6) chemotherapy protocols in patients with high-risk stage III colon cancer in the adjuvant setting.
详细描述
After inclusion and non-inclusion criteria have been fulfilled and the patient consent has been obtained, the patient will be included and randomized in the trial. The maximum delay allowed between the signature of the consent form by the patient and the randomization in the study is 28 days.
The randomization procedure using minimization method will allocate the treatments mFOLFIRINOX or mFOLFOX 6 with a 1:1 ratio, and will be stratified by the following criteria:
- Perforation or urgent surgery versus no perforation and no urgent surgery.
- T1-T3N2 vs T4aN1 versus T4bN1 versus T4N2.
- Right colon (right of splenic flexure) vs left colon.
- Country (France vs Canada vs Italy). Patient eligible and who have signed the informed consent will be randomized in one of the two treatments arms and will receive every 14 days their treatment for a duration of 12 cycles.
Arm A: mFOLFIRINOX Arm B: mFOLFOX 6
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The primary end-point is the Disease Free Survival (DFS) at 3 years, defined as the time from the date of randomization up to the date of:
- first local, regional or distant relapse;
- second colorectal cancer;
- death from any cause included treatment-related death. Other primary cancer (except second primary colorectal) will be ignored. Second primary cancer will be recorded to have the opportunity of evaluating other definition of DFS.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to study treatment start. Incompletely healed wounds or anticipation of the need for major surgical procedure during the course of the study
- •Metastatic disease
- •Presence of inflammatory bowel disease and/or ileus
- •Known hypersensitivity reaction to any of the components of study treatments.
- •Pregnancy (absence to be confirmed by β-hCG test) or breast-feeding period
- •Clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia (for men: QTc ≥450 msec, for women: QTc ≥470 msec)
- •Previous malignancy in the last 5 years except curative treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix
- •Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent
- •History or current evidence on physical examination of central nervous system disease or peripheral neuropathy ≥ grade 1 Common Toxicity Criteria for Adverse Events (CTCAE) v4.
- •Any significant disease which, in the investigator's opinion, would exclude the patient from the study.
- •Patient with a DPD deficiency or UGT1A1 homozygous 7/7; the test should be done for all patients before 5-FU administration, according to ANSM communication regarding recommendation about high risk of no testing DPD in patient before 5-FU administration; (Appendices 8 to 11).
- •Patients already included in another therapeutic trial involving an experimental drug
研究组 & 干预措施
Arm A
mFOLFIRINOX Folfox Protocol + Irinotecan
干预措施: Irinotecan (Drug)
Arm A
mFOLFIRINOX Folfox Protocol + Irinotecan
干预措施: Folfox Protocol (Drug)
Arm B
mFOLFOX 6 Folfox Protocol
干预措施: Folfox Protocol (Drug)
结局指标
主要结局
Disease Free Survival (DFS)
时间窗: 3 YEARS after inclusion
DFS : defined as the time from the date of randomization up to the date of: * first local, regional or distant relapse; * second colorectal cancer; * death from any cause included treatment-related death.
次要结局
- Disease Free Survival(2 YEARS after inclusion)
- Overall Survival(5 YEARS after inclusion)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](2 YEARS after inclusion)