mFOLFOXIRI Compared to mFOLFOX6 or CapeOx as Adjuvant Chemotherapy for Stage IIIB or Stage IIIC Colorectal Cancer: A Randomized Controlled Clinical Research
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 2-year Disease-free survival
研究概览
简要总结
This study will focus on postoperative patients of stage IIIB or stage IIIC colorectal cancer. These patients will start to accept chemotherapy in 3-4 weeks after operation, these patients were randomly divided into two groups, one group will accept adjuvant chemotherapy of mFOLFOX6 or CapeOX; another group will use mFOLFOXIRI, they can change the regimen to mFOLFOX6 or CapeOx after accepting not less than two complete chemotherapy regimen, if can not tolerate the adverse reaction of mFOLFOXIRI. The efficacy and safety of adjuvant chemotherapy will be compared between the two groups. Disease-free survival, overall survival, incidence of adverse reaction of chemotherapy and postoperative quality of life will be recorded.
详细描述
This trial is a two-arm, open labelled, prospective, randomized phase II studies. The postoperative stage of eligible patients was stage IIIB or stage IIIC. These high risk patients will be randomly assigned, in a 1:1 ratio, to receive either mFOLFOXIRI or mFOLFOX6/CapeOx for 6 months as 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
- •Age 18-75 years
- •ECOG PS 0-1
- •Curative surgery (R0 resection)
- •ypStage III B and ypStage III C
- •No distant metastasis after surgery
排除标准
- •any treatment before surgery including chemotherapy, radiotherapy and targeted agents.
- •Previous or concurrent cancer that is distinct in primary site or histology from colon cancer within 5 years prior to randomization.
- •Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment.
- •Heart failure grade III/IV (NYHA-classification).
- •Unresolved toxicity higher than CTCAE v.4.0 Grade 1 attributed to any prior therapy/procedure.
- •Subjects with known allergy to the study drugs or to any of its excipients.
- •Current or recent (within 4 weeks prior to starting study treatment) treatment of another investigational drug or participation in another investigational study.
- •Breast- feeding or pregnant women
- •Lack of effective contraception
研究组 & 干预措施
mFOLFOXIRI adjuvant chemotherapy
Patients will receive mFOLFOXIRI once every two weeks for 12 cycles as adjuvant chemotherapy. They can change the regimen to mFOLFOX6 or CapeOx after accepting not less than two complete chemotherapy regimen, if can not tolerate the adverse reaction of mFOLFOXIRI. Total 24 weeks.
干预措施: mFOLFOXIRI (Drug)
mFOLFOXIRI adjuvant chemotherapy
Patients will receive mFOLFOXIRI once every two weeks for 12 cycles as adjuvant chemotherapy. They can change the regimen to mFOLFOX6 or CapeOx after accepting not less than two complete chemotherapy regimen, if can not tolerate the adverse reaction of mFOLFOXIRI. Total 24 weeks.
干预措施: mFOLFOX6 OR CapeOx (Drug)
mFOLFOX6 or CapeOx adjuvant chemotherapy
Patients will receive mFOLFOX6 once every two weeks for 12 cycles as adjuvant chemotherapy or CapeOx once every three weeks for 8 cycles as adjuvant chemotherapy. Total 24 weeks.
干预措施: mFOLFOX6 OR CapeOx (Drug)
结局指标
主要结局
2-year Disease-free survival
时间窗: up to 2 years
Defined as the time from randomization to relapse or death, whichever occurred first
次要结局
- Overall survival(up to 3 years)
- The grade of toxicity will be assessed using the NCI common toxicity criteria, version 5.0.(up to 3 years)
- QLQ-C30 Quality of Life questionnaire(up to 3 years)
- Quality of Life assessed by SF-36(up to 3 years)