ISRCTN05842222已完成不适用
Phase II randomized trial comparing 5-fluorouracil in continuous infusion and cisplatin (FP) versus leucovorin, bolus 5-fluorouracil and cisplatin (FLP) in metastatic gastric, pancreatic and oesophageal cancer
French Federation of Digestive Cancers (Fédération Francophone de la Cancérologie Digestive [FFCD]) (France)0 个研究点目标入组 232 人开始时间: 2005年9月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 232
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Histologically proven carcinoma of the oesophagus, the stomach or the pancreas, with a measurable metastatic disease (=15 mm) and without indication of radiotherapy and/or surgery; no prior chemotherapy for metastatic disease and, in case of adjuvant chemotherapy, no regimen containing cisplatin; age =75 years and World Health Organization (WHO) performance status <2; adequate baseline organ function, defined as neutrophile count =1500/mm^3, platelet count =100,000/mm^3 and creatinine level <1.25 normal level; in case of patient older than 70 years and/or creatinine level between 1 and 1.25 normal limit, creatinine clearance had to be more than 60 ml/mm; and written informed consent approved by the local Ethical Committee was given by all the participants before they entered the study.
排除标准
- •Severe uncontrolled co-morbidities, brain metastases
研究者
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