NCT00868816已完成4 期
A Prospective, Randomized, Control Trial of Oxaliplatine Based Adjuvant Chemotherapy for Stage II/III Colorectal Cancer: 8 Cycles vs 12 Cycles
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- disease-free survival
研究概览
简要总结
The purpose of this study is to investigate which oxaliplatie based adjuvant method (8 cycles or 12 cycles) is better for patients receiving curative colorectal cancer resection.
详细描述
We administered 5-FU, lv and Oxaliplatin as adjuvant chemotherapy (3 weeks per cycle) to patients with Stage II or Stage III colorectal cancer. 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
- 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
- •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)
排除标准
- •age >= 75
- •severe major organ dysfunction
- •WHO performance status of >1
- •Stage I or Stage IV
研究组 & 干预措施
1
Experimental
12 cycles of oxaliplatine based adjuvant chemotherapy
干预措施: 12 cycles of oxaliplatine based adjuvant chemotherapy (Drug)
2
Active Comparator
8 cycles of oxaliplatine based adjuvant chemotherapy
干预措施: 8 cycles of oxaliplatine based adjuvant chemotherapy (Drug)
结局指标
主要结局
disease-free survival
时间窗: 5 years after operation
次要结局
- overall survival liver metastasis-free survival(5 years after operation)
研究者
研究点 (1)
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