EUCTR2007-002257-23-FR进行中（未招募）1 期
A phase III randomized study evaluating surgery of residual disease in patients withmetastatic gastro-intestinal stromal tumor responding to Imatinib mesylate.
European Organization for Research and Treatment of Cancer0 个研究点目标入组 350 人开始时间: 2009年4月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •¨ Histologically confirmed GIST expressing CD117+, or with documented mutation of the KIT or PDGFRA gene
- •¨ Metastatic disease (liver and/or abdominal cavity); no extra-abdominal metastases
- •¨ Treatment with imatinib administered for 6-12 months, resulting in CR,
- •PR or SD, without PD since the start of Imatinib therapy (RECIST)
- •¨ Measurable disease (RECIST) before start of imatinib
- •¨ Surgically resectable residual disease (assessed on CT scan/ MRI)
- •¨ Age = 18 years; performance status 0 to 1 (WHO scale)
- •¨ Adequate hematologic and organ function
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •¨ Prior treatment with imatinib or other tyrosine kinase inhibitors (for any reason) in the adjuvant or neoadjuvant setting
研究者
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