NCT00275210已完成3 期
Multicenter International Study of Oxaliplatin/ 5FU-LV in the Adjuvant Treatment of Colon Cancer
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 2,246
- 试验地点
- 19
- 主要终点
- To to detect occurrence of relapse the following examinations have to be performed for 5 years:
研究概览
简要总结
To evaluate the FOLFOX regimen versus LV5FU2 in the adjuvant treatment of stage II and III colon cancer.
Primary objective: Disease Free Survival (DFS) Secondary objective: Overall Survival (OS), safety (including long term toxicity)
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
- •Main selection criteria:
- •Histologically proven stage Dukes " B2 " (stage II: T3-T4 N0 M0) and " C " (stage III: any T N1-2 M0) colon carcinoma. The inferior pole of the tumor must be above the peritoneal reflection (> 15 cm from the anal margin)·
- •Complete resection of the primary tumor without gross or microscopic evidence of residual disease
- •Treatment within 7 weeks following surgery
- •Age 18-75 years old
- •ECOG PS £ 2
- •No prior chemo, immuno or radiotherapy
排除标准
- 未提供
结局指标
主要结局
To to detect occurrence of relapse the following examinations have to be performed for 5 years:
Every 6 months for ultrasound or abdominopelvic CT scan and CEA determination,
Every year for chest X-ray and colonoscopy for non polyp free patient,
Every 3 years colonoscopy for polyp free patient
次要结局
- Every 2 weeks clinical and laboratory tests (hematological, creatinine and liver tests) for safety evaluation during treatment then every 6 months neurological examination Date of death for OS
研究者
研究点 (19)
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