A Prospective,Multi-Center,Randomized Control Trial of Preoperative Hepatic and Regional Arterial Chemotherapy(PHRAC) Using Oxaliplatin, Fluorodeoxyuridine(FUDR) and Mitomycin C(MMC) to Prevent Postoperative Liver Metastasis of Colorectal Cancer
试验速览
- 阶段
- 3 期
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- 5 years disease-free survival
研究概览
简要总结
The purpose of this study is to investigate whether preoperative hepatic and regional arterial chemotherapy are able to prevent liver metastasis and improve overall survival in patients receiving curative colorectal cancer resection.
详细描述
We administered FUDR, MMC and Oxaliplatin as preoperative hepatic and regional arterial chemotherapy (PHRAC) to patients with Stage II or Stage III colorectal cancer without apparent liver metastasis based on a thorough preoperative evaluation. 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
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 74 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
- •Stage II (T3-4, N0, M0) or Stage III (T0-4, N1-2, M0) disease (according to the 1997 revision of the International Union Against Cancer TNM staging system) as determined by a preoperative evaluation that included colonoscopy and an abdominal computed tomography (CT) scan
排除标准
- •age >= 75
- •severe major organ dysfunction
- •WHO performance status of >1
- •prior cancer therapy
- •Stage I or Stage IV
研究组 & 干预措施
B
PHRAC was performed 7 days before surgery. Adjuvant chemotherapy using FOLFOX7 was done for 8 cycle with 28 days after surgery.
干预措施: Preoperative hepatic and regional arterial chemotherapy using oxaliplatin, MMC and FUDR (Procedure)
A
Adjuvant chemotherapy using FOLFOX7 was done for 8 cycle with 28 days after surgery.
干预措施: surgery (Procedure)
结局指标
主要结局
5 years disease-free survival
时间窗: 5 years after operation
次要结局
- 5 years overall survival and liver metastasis-free survival(5 years after operation)