NCT00309530已完成3 期
A Prospectively Randomized Phase III Study on Adjuvant Chemotherapy and Adjuvant Chemo-Immunotherapy in Patients With Operated Colon Carcinoma Dukes C (Stage III; T1-4, N1-30, M0).
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 598
- 试验地点
- 32
- 主要终点
- Recurrence-free survival
研究概览
简要总结
This clinical investigation examined the effectivity 5-fluorouracil, of adding levamisol or interferon to 5-fluorouracil, and of a 5-fluorouracil/levamisol/interferon triple combination, in terms of recurrence-free and overall survival in curatively operable colon carcinoma Stage III.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically verified, curatively operated colon carcinoma Stage III (R0, T1-4, N1-3, M0)
- •Age: less than 80 years
- •WHO Performace Status > 2
- •Adequate bone marrow reserve
- •Informed consent
排除标准
- •Rectal cancer
- •R1, R2, carcinosis peritonei
- •Start of chemo- or chemo-immunotherapy > 42 days postop; other adjuvant radiotherapy, chemotherapy or immunotherapy
- •Serious concomitant disease, in particular chronically inflammatory large intestine, cardiopathic disease, malignant second carcinoma
结局指标
主要结局
Recurrence-free survival
Overall survival
次要结局
未报告次要终点
研究者
研究点 (32)
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