TAC vs TACE Plus folfox4 as the Treatment of Unresectalbe Liver Metastasis of Colorectal Cancer With Resection of the Primary Tumor: a Prospective, Randomized, Control Trial
试验速览
- 阶段
- 4 期
- 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 or TACE 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 TAC(oxaliplatin,FUDR and MMC) or FOLFOX4 plus TACE(oxaliplatin,FUDR,MMC and embolision) 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 chemoembolision (TACE) using oxaliplatin, fudr, mmc and iodine. Then begin folfox4 again.
干预措施: TACE + folfox 4 (Procedure)
2
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)
结局指标
主要结局
overall survival
时间窗: 5 years after operation
次要结局
- resection rate of liver metastasis progression-free survival(5 years after operation)