A Prospective,Randomized Control Trial of Intraoperative Intraportal Chemotherapy (5-FU and Oxaliplatin) Combined With Adjuvant Chemotherapy to Prevent Liver Metastasis in Patients Receiving Curative Colorectal Cancer Resection.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- 3 years disease-free survival
研究概览
简要总结
In this study, the investigators assessed whether intraoperative Intraportal infusion of 5-FU and oxaliplatin is able to prevent liver metastasis in patients receiving curative colorectal cancer resection.
详细描述
In this study, the investigators assessed whether intraoperative Intraportal infusion of 5-FU and oxaliplatin is able to prevent liver metastasis and improve survival in patients with Stage II or Stage III colorectal cancer without apparent liver metastasis based on a thorough preoperative evaluation.
Patients with stage II or stage III colorectal cancer (CRC) were randomly assigned to two arms.Arm A: 5-FU 1g and oxaliplatin 100mg + curative resection (study group, n=132). Arm B: curative resection alone (control group, n=132).Follow-up: X-ray, US, CT, blood test, colonoscopy,every 3months.
The study endpoints were disease-free survival, overall survival, and liver metastasis-free survival as evaluated by intent-to-treat analysis.
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
- Single (Participant)
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
- 未提供
研究组 & 干预措施
ARM A
Patients with stage II or stage III colorectal cancer (CRC) were randomly assigned to two arms. In ARM A, patients accepted intraoperative intraportal infusion of 5-FU 1g and oxaliplatin 100mg + curative resection+mFOLFOX6.
干预措施: 5-FU and oxaliplatin (Drug)
ARM A
Patients with stage II or stage III colorectal cancer (CRC) were randomly assigned to two arms. In ARM A, patients accepted intraoperative intraportal infusion of 5-FU 1g and oxaliplatin 100mg + curative resection+mFOLFOX6.
干预措施: colorectal cancer resection+ adjuvant chemotherapy (mFOLFOX6) (Procedure)
ARM B
Patients with stage II or stage III colorectal cancer (CRC) were randomly assigned to two arms. In arm B, patients accepted curative resection + mFOLFOX6 alone.
干预措施: colorectal cancer resection+ adjuvant chemotherapy (mFOLFOX6) (Procedure)
结局指标
主要结局
3 years disease-free survival
时间窗: 3 years after operation
PFS will be defined as the period from the first day of CRC resection to the date of disease recurrence or to death.
次要结局
- 3 years overall survival and metastasis-free survival(3 years after operation)
研究者
Xu jianmin
Jianmin Xu, PhD Fudan University
Fudan University