ACTRN12609000681257尚未招募3 期
A phase III randomized study evaluating surgery of residual disease in patients with metastatic gastro-intestinal stromal tumor responding to imatinib mesylate
European Organisation for Research and Treatment of Cancer (EORTC)0 个研究点目标入组 350 人开始时间: 2009年8月10日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 350
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Histologically confirmed gastro-intestinal stromal tumour (GIST).
- •- Metastatic disease (liver and/or abdominal cavity)
- •- Treatment with imatinib mesylate for 6 - 12 months either as standard care or within other clinical studies.
- •- Progression not experienced on imatinib.
- •- Surgically resectable disease.
排除标准
- •- Previous treatment with imatinib or other tyrosince kinase inhibitor (TKI) other than treatment with imatinib in the past 6 - 12 months.
- •- Extra-abdominal matastases
- •- Myocardial infarction, unstable or uncontrolled cardiac disease within 6 months prior to study entry
- •- Coumarin-type anticoagulant >2mg/day within 7 days prior to study entry
- •- Pregnancy/breastfeeding
研究者
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