EUCTR2007-002257-23-IT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. - ND
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 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
- •š Histologically confirmed GIST expressing CD117+, or with
- •documented mutation of the KIT or PDGFRA gene
- •š Metastatic disease (liver and/or abdominal cavity); no extra-abdominal
- •š Treatment with imatinib administered for 6-12 months, resulting in CR,
- •PR or SD, without PD since the start of Imatinib therapy (RECIST)
- •š No prior treatment with imatinib or other tyrosine kinase inhibitors (for
- •any reason) in the adjuvant or neoadjuvant setting
- •š Measurable disease (RECIST) before start of imatinib
- •š Surgically resectable residual disease (assessed on CT scan/ MRI)
- •š Age ≥ 18 years; performance status 0 to 1 (WHO scale)
- •š 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
- •-myocardial infarction, unstable or uncontrolled cardiac disease within 6 months of study
- •-uncontrolled hypertension (DBP>95 mm Hg; SBP>170 mm Hg)
- •-history of arterial thrombosis or deep vein thrombosis within 1 year of study entry
- •- bleeding diathesis, coagulopathy or major bleeding within 6 months of study entry
- •- coumadin-type anticoagulant > 2mg/day within 7 days of study entry
- •-major surgery within 28 days of study entry
- •-prohibited co-medication which interacts moderately or strongly with the CYP3A system
- •within 14 days of study entry (see detailed list on http://medicine.iupui.edu/flockhart/table.htm),
- •until both pharmacokinetic samples are taken.
- •- severe and/or uncontrolled concurrent medical disease (e.g., uncontrolled diabetes,
- •uncontrolled chronic renal disease, uncontrolled liver disease, including chronic viral hepatitis
- •judged at risk of reactivation, uncontrolled active infection, such as HIV infection, etc.).
- •- prior malignancy (other than in situ cervical cancer, in situ melanoma, or basal or squamous
- •cell cancer of the skin) unless treated with curative intent and without evidence of disease for at
- •least 3 years
- •- any psychological, familial, sociological or geographical condition potentially
- •hampering compliance with the study protocol and follow-up schedule; those conditions should
- •be discussed with the patient before randomization in the trial
研究者
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