EUCTR2004-001810-16-IT进行中（未招募）1 期
Intermediate and high risk localized, completely resected, gastrointestinal stromal tumors (GIST) expressing KIT receptor: a controlled randomized trial on adjuvant Imatinib mesylate (Glivec) versus no furthrer therapy complete surgery. - EORTC 62024
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
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 proven diagnosis of GIST-Intermediate-high risk of relapse- Surgery performed from 2 weeks to 3 months before randomization- Non evidence of residual macroscopic disease after surgery-No prior radiation therapy, no prior chemotherapy for GIST, no prior Imatinib mesylate or any molecolar targeted or biological therapy-Absence of distant metastases including absence of any peritoneal lesion not contiguous to the primary tumor-Age >/= 18- WHO PS =0-2-No class 3/4 cardiac problems- No severe/uncontrolled concurrent medical desease-No prior or ongoing other malignancy, exept adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or adequately treated cancer with eradicative intent for which the patient has been continuously disease free for at least 5 years- Adequated liver function (serum bilirubin = 1.5xIULN,AST or ALT = 2.5IULN)-Adequated renal function (serum creatinin < 1.5 xIULN-ANC >/=1.5 x109/l-platelet count >/=100x109/l-baseline Hemoglobin >/=9g/dl-Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •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 radiation therapy, prior chemotherapy for GIST, prior Imatinib mesylate or any molecolar targeted or biological therapy-Distant metastases including peritoneal lesion not contiguous to the primary tumor-severe/uncontrolled concurrent medical desease-Ongoing pregnancy or nursing-Use of coumarine derivatives at the time of treatment start-Unadequated liver or renal function- Any psychological, familial, sociological, condition potentially hampering compliance with the study protocol and follow up
研究者
相似试验
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Intermediate and high risk localized, completely resected, gastrointestinal stromal tumors (GIST) expressing KIT receptor: a controlled randomized trial on adjuvant Imatinib mesylate (Glivec) versus no further therapy after complete surgeryEUCTR2004-001810-16-BEEuropean Organisation for Research and Treatment of Cancer900
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进行中（未招募）
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Intermediate and high risk localized, completely resected, gastrointestinal stromal tumors (GIST) expressing KIT receptor: a controlled randomized trial on adjuvant Imatinib mesylate (Glivec) versus no further therapy after complete surgeryGastrointestinal stromal tumors (GIST) are mesenchymal neoplasms usually arising from the gastrointestinal wall. Pathologically,they present with spindle cells in most cases. Immunohistochemically, GIST cells are almost always positive for CD117.CD117 corresponds to the KIT receptor, a tyrosine kinase receptor which is altered in GIST due to a mutation to the c-kit oncogene. This event is held to be critical for GIST pathogenesis.MedDRA version: 15.1Level: PTClassification code 10051066Term: Gastrointestinal stromal tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2004-001810-16-DKEuropean Organisation for Research and Treatment of Cancer900
进行中（未招募）
1 期
Intermediate and high risk localized, completely resected, gastrointestinal stromal tumors (GIST) expressing KIT receptor: a controlled randomized trial on adjuvant Imatinib mesylate (Glivec) versus no further therapy after complete surgeryGastrointestinal stromal tumors (GIST) are mesenchymal neoplasms usually arising from the gastrointestinal wall. Pathologically,they present with spindle cells in most cases. Immunohistochemically, GIST cells are almost always positive for CD117.CD117 corresponds to the KIT receptor, a tyrosine kinase receptor which is altered in GIST due to a mutation to the c-kit oncogene. This event is held to be critical for GIST pathogenesis.MedDRA version: 14.1 Level: PT Classification code 10051066 Term: Gastrointestinal stromal tumour System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2004-001810-16-GBEuropean Organisation for Research and Treatment of Cancer908
已完成
3 期
Adjuvant GIST TrialACTRN12605000712606AGITG400