A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of UFT Compared With Surgery Alone in Patients With Dukes C Colorectal Cancer (NSAS-CC)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- Relapse-free survival and overall survival
研究概览
简要总结
This is a controlled study designed to compare relapse-free survival and overall survival in patients receiving UFT with those in patients receiving surgery alone. Patients will be randomly assigned to surgery alone or surgery followed by UFT within 6 weeks after curative resection. To assess treatment efficacy, data on recurrence and survival will be collected for 5 years after enrollment of the last patient. To evaluate safety, data on adverse events will be collected for 12 months after the start of treatment.Evaluations will be separately done for colon cancer and rectal cancer.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20 to 75
- •Performance status 0 , 1, or 2 (ECOG)
- •Hematopoietic WBC ≥ 4,000/mm^3 Platelet ≥ 100,000/mm^3
- •Hepatic AST and ALT ≤ 2 times upper limit of normal(ULN) Total bilirubin ≤ 1.2mg/dL
- •Renal BUN ≤ 25mg/dL Creatinine ≤ 1.5mg/dL
排除标准
- •Prior anticancer treatment
研究组 & 干预措施
1
UFT (uracil, tegafur)
干预措施: UFT (uracil, tegafur) (Drug)
2
Surgery alone
干预措施: Surgery alone (Procedure)
结局指标
主要结局
Relapse-free survival and overall survival
时间窗: every course for first three courses, then every other course
次要结局
- Adverse events(any time)