mFOLXOX6 Versus FOLFIRI for Colorectal Patients Recurrence After Oxaplatin Based Adjuvant Chemotherapy（NEW RECHALLENGE）- A Multicenter Open Prospective Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 328
- 试验地点
- 1
- 主要终点
- ORR（objective response rate）
研究概览
简要总结
A multicenter,open,prospective randomized controlled trial;11 study center in China; Plan to enroll 328 patients（ Power Analysis and Sample Size ）.Comparing FOLFIRI with mFOLFOX6,Superiority design.Investigate difference PFS,ORR,R0 resection rate,OS ,QoL and Safety from two regimens Stratification factors : Analyzing patients recurrence within 6-12months,and 12-18months .Obtain definite chemotherapy regimen shift opportunity for patients recurrence/metastasis after adjuvant chemotherapy.
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
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
- •18-75 years，male or female Colorectal adenocarcinoma Accepting more than 4 cycles oxaplatin based adjuvant chemotherapy after radical operation Reccurrence in 6-18 months after adjuvant chemotherapy At least one assessable lesions No intestinal obstruction ECOG 0-1 Estimated survival≥ 3 months CBC：WBC>4×109/L，PLT>80×109/L，Hb>90g/L， Liver function：ALT or AST < 2× normal maximum value， T-bile<1.5× normal maximum value without hepatic metastatic， ALT or AST < 5× normal maximum value， T-bile<1.5× normal maximum value with hepatic metastatic Cr<1.8mg/dl Signed informed consent
排除标准
- •Locally resectable lesions Grade 2-4 oxaliplatin induced neurotoxicity Arrhythmias，coronary heart disease，or congestive heart failure（NYHA≥grade 2） requiring treatment Poorly controlled hypertension HIV infected or active HBV or HCV infected Active serious infection Cachexia or organ function decompensation Multiple primary carcinoma except carcinoma in situ of skin and cervix Participate in other clinical studies at the same time Serious heart or brain disease Drug abuse or other serious psychosocial diseases Suspected trial drug allergy Other factors affecting patient safety and compliance Pregnant or lactating women，or fertility without adequate contraceptive measures
研究组 & 干预措施
FOLFIRI
Irinotecan 180 mg/m2 I.V 30-90 min，D1；
LV 400 mg/m2 I.V.，D1；
5-FU 400 mg/m2 IVP，d1,1200 mg/m2/d×2 days（Total:2400 mg/m2，Continuous intravenous infusion,46~48 hours,）
Repeat Every 14 days
干预措施: FOLFIRI (Drug)
mFOLFOX6
Oxaplatin 85 mg/m2 I.V 120 min，D1；
LV 400 mg/m2 I.V.，D1；
5-FU 400 mg/m2 IVP，d1,1200 mg/m2/d×2 days（Total:2400 mg/m2，Continuous intravenous infusion,46~48 hours,）
Repeat Every 14 days
干预措施: FOLFIRI (Drug)
结局指标
主要结局
ORR（objective response rate）
时间窗: At the end of Cycle 3（6 weeks after first chemotherapy）
imaging evaluation
次要结局
- PFS(At the end of Cycle 6(each cycle is 14 days))
- OS(At the end of Cycle 12(each cycle is 14 days))
- R0 resection rate R0 resection rate R0 resection rate R0 resection rate R0 resection rate(At the end of Cycle 12(each cycle is 14 days))
- QoL（quality of life）(At the end of Cycle 12)