Postoperative folfox4 Only vs folfox4 Plus TAC in the Treatment Unresectable Liver Metastasis of Colorectal Cancer: a Randomized,Prospective,Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
The purpose of this study is to investigate whether TAC plus FOLFOX4 are able to improve resection rate and overall survival in patients receiving primary colorectal tumor resection than given FOLFOX4 only.
详细描述
We administered three cycles FOLFOX4 plus on TAC (oxaliplatin, FUDR and MMC) or FOLFOX4 only to primary colorectal tumor resected patients with unresected liver metastasis. The study endpoints were resection rate of liver metastasis, progression-free survival, overall 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
- 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 < 75 years with histologically proven adenocarcinoma of the colon or rectum
- •no severe major organ dysfunction
- •WHO performance status of 0 or 1
- •no prior cancer therapy
- •with measurable unresectableliver metastasis
- •without other metastasis
排除标准
- •age >= 75
- •severe major organ dysfunction
- •WHO performance status of >1
- •prior cancer therapy
- •with other metastasis
研究组 & 干预措施
1
folfox4 chemotherapy was done within 28 days after primary surgery. Per 3 weeks, patients will receive one cycle. After 3 cycles, patients will received transhepatic arterial chemotherapy(TAC) using oxaliplatin, fudr and mmc. Then begin folfox4 again.
干预措施: tac + folfox4 (Procedure)
2
folfox4 chemotherapy was done within 28 days after primary surgery. Per 3 weeks, patients will receive one cycle.
干预措施: Folfox4 (Procedure)
结局指标
主要结局
overall survival
时间窗: 5 years after diagnosis
次要结局
- progression free survival(5 years after diagonsis)