ISRCTN63599281已完成不适用
A phase III randomised 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) (Belgium)0 个研究点目标入组 350 人开始时间: 2010年4月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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
入排标准
- 性别
- All
入选标准
- •1. Histologically confirmed GIST expressing CD117+, or with documented mutation of the KIT or PDGFRA gene
- •2. Metastatic disease (liver and/or abdominal cavity); no extra-abdominal metastases
- •3. Treatment with imatinib administered for 6 - 12 months, resulting in complete remission (CR), partial remission (PR) or stable disease (SD), without progressive disease (PD) since the start of imatinib therapy (Response Evaluation Criteria in Solid Tumours [RECIST])
- •4. Measurable disease (RECIST) before start of imatinib
- •5. Surgically resectable residual disease (assessed on computed tomography [CT] scan/magnetic resonance imaging [MRI])
- •6. Aged greater than or equal to 18 years (either sex)
- •7. World Health Organization (WHO) performance status 0 to 1
- •8. Adequate haematological and organ function
排除标准
- •No prior treatment with imatinib or other tyrosine kinase inhibitors (for any reason) in the adjuvant or neoadjuvant setting
研究者
相似试验
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 mesylateGastro-intestinal stromal tumour (GIST)Cancer - Other cancer typesACTRN12609000681257European Organisation for Research and Treatment of Cancer (EORTC)350
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.bowel wall cancer1001799010017998GISTNL-OMON32805European Organisation for Research in Treatment of Cancer (EORTC)60
进行中（未招募）
不适用
A phase III randomized study evaluating surgery of residual disease in patients withmetastatic gastro-intestinal stromal tumor responding to Imatinib mesylate.EUCTR2007-002257-23-GBEuropean Organization for Research and Treatment of Cancer350
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.Metastatic gastro-intestinal stromal tumorMedDRA version: 9.1Level: LLTClassification code 10062427Term: Gastrointestinal stromal tumorEUCTR2007-002257-23-FREuropean Organization for Research and Treatment of Cancer350
进行中（未招募）
不适用
A phase III randomized study evaluating surgery of residual disease in patients withmetastatic gastro-intestinal stromal tumor responding to Imatinib mesylate.EUCTR2007-002257-23-NLEuropean Organization for Research and Treatment of Cancer350