NL-OMON32805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. - De rol van chirurgie bij gemetastaseerd gastro-intestinale stromatumoren.
European Organisation for Research in Treatment of Cancer (EORTC)0 个研究点目标入组 60 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
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
- 年龄范围
- 18 至 99（—）
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
- •* Treatment with Imatinib administered for 6-12 months, resulting in CR,
- •PR or SD, without PD since the start of Imatinib therapy (RECIST)
- •* No previous treatment with Imatinib or other tyrosine kinase inhibitors (for
- •whatever reason) in the adjuvant of neoadjuvant setting
- •* 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
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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