Preoperative Transhepatic Arterial Chemotherapy in the Treatment of Liver Metastasis of Resectable Colorectal Cancer
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- progression free survival
研究概览
简要总结
The purpose of this study is to investigate whether preoperative TAC is able to improve progression free survival and overall survival in patients receiving liver metastasis resection of colorectal cancer.
详细描述
We administered TAC(oxaliplatin,FUDR and MMC) 7 days before liver metastasis resection of colorectal cancer. The study endpoints were progression free survival and 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
- •resectable liver metastasis
- •remnant liver volume >= 70%
- •without other organ metastasis or peritoneum metastasis
- •without contradiction of cardiac and pulmonary diseases
排除标准
- •age > 75 years
- •unresectable liver metastasis
- •remnant liver volume < 50%
- •with other organ metastasis or peritoneum metastasis
- •with contradiction of cardiac and pulmonary diseases
研究组 & 干预措施
1
transhepatic arterial chemotherapy (TAC) were given 7 days before liver metastasis resection. Adjuvant folfox4 chemotherapy was done within 28 days after surgery.
干预措施: tac + folfox4 (Drug)
2
Liver metastasis resection was done without TAC. Adjuvant folfox4 chemotherapy was done within 28 days after surgery.
干预措施: folfox4 (Drug)
结局指标
主要结局
progression free survival
时间窗: 5 years after operation
次要结局
- overall survival(5 years after operation)