NCT00675194已完成2 期
A Prospective, Open, Comparative Multicentre Phase II Study for the Evaluation of Irinotecan and Capecitabine Versus Cisplatin and Capecitabine in Advanced Gastric Adenocarcinoma or Gastric-Oesophagal Junction
Johannes Gutenberg University Mainz1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2003年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- response rate
研究概览
简要总结
The purpose of this study is to determine which Arm (capecitabine + irinotecan versus capecitabine + cisplatin) shows higher response rates in the treatment of advanced gastric-oesophagal cancer
Furthermore, comparison of progression-free survival, 1-year survival, Quality of Life and safety
详细描述
capecitabine + irinotecan versus capecitabine + cisplatin, as published by Kang et al. (ASCO 2006)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •gastric or gastric-oesophagal junction adenocarcinoma
- •unidimensional measurable disease
- •Karnofsky index >/=60%
排除标准
- •prior chemo- or radiotherapy
- •colorectal diseases
- •brain metastases
结局指标
主要结局
response rate
次要结局
- safety
- progression free survival
- 1 year survival
- Quality of Life
- Analysis of the dose and efficacy of Epoetin beta weekly in anaemic patients
研究者
研究点 (1)
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