NCT00512304已完成2 期
Feasibility Study of 2 Parallel Phases II Pre or Postgastrectomy in Patients With Gastric Cancer (FOLFIRI-radiotherapy Plus 5 Fluorouracil-surgery or Surgery-FOLFIRI-radiotherapy Plus 5 Fluorouracil)
University Hospital, Rouen2 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2007年8月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- feasibility of treatment
研究概览
简要总结
Post-operative radio-chemotherapy decrease the recurrence risk of gastric cancer(N Engl J Med 2001). However the chemotherapy regimen (5 fluorouracil IV bolus) used was toxic and suboptimal. We propose to evaluate in adjuvant situation an active and well tolerate chemotherapy regimen (FOLFIRI)in patients with metastatic gastric cancer. During the radiotherapy we will use 5 FU continue infusion as previously reported. The global design of adjuvant treatment will be four FOLFIRI courses, radiotherapy (45 Gy)with 5FU IV continue then four FOLFIRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •gastric adenocarcinoma histologically confirmed
- •tumor T3 or N+ at the pretherapeutic staging (Scanner and endoscopic ultrasound)
- •performance status WHO<2
- •serum albumin >30 gr/l
- •weight loss < 10% in the next 6 months
- •signed informed consent form
排除标准
- •metastatic disease
- •prior abdominal radiotherapy
结局指标
主要结局
feasibility of treatment
时间窗: at the end of the treatment
次要结局
未报告次要终点
研究者
研究点 (2)
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