NCT00189657Unknown3 期
5FU/VL Vs LV5FU2 + CPT11 in Stage II-III Resected Rectal Cancer
Association Européenne de Recherche en Oncologie2 个研究点 分布在 1 个国家开始时间: 2005年9月19日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 试验地点
- 2
研究概览
简要总结
The main objective of this randomized trial is to compare 5FU/LV (Mayo-Clinic regimen or LV5FU2) to LV5FU2 + irinotécan in patients with resected B2 and C rectal cancer. Preoperative radiotherapy is recommended but not mandatory. Main endpoint is disease free survival. Secondary endpoint are overall survival, time to local recurrence, time to distant metastases, and tolerance. A total of 600 patients will be included in the trial.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •rectal adenocarcinoma
- •R0 surgery
- •T3, N0, M0 or T4, N0, M0 or N1,2, M0
- •chemotherapy can be started within 8 weeks after surgery
- •Age > 18
- •Performance status ECOG < 3
- •preoperative radiotherapy allowed
- •preoperative chemotherapy with 5FU +/- LV allowed
- •Neutrophiles > 1 500/mm3; Pl. > 100 000/mm3
- •Transaminases < 2 x UNL; Alcalines Phosphatases < 2 x UNL; Bili < 1.1 UNL
- •creatininemia < 120 µmol/l and/or clearance of creatininemia > 60 ml/mn
- •Written informed consent before inclusion
排除标准
- •postoperative radiotherapy
- •Distant metastases
- •Contraindication to any drug contained in the chemotherapy regimens
- •Any serious active disease or co-morbid medical condition including digestive inflammatory disease
- •Gilbert disease
- •severe toxicity of radiotherapy
- •Pregnancy or breast feeding
- •Absence of contraception in non menopausal women
- •Adult patient unable to give informed consent because of intellectual impairment
- •Concomitant participation to another trial
研究者
研究点 (2)
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