EUCTR2016-003774-40-FI进行中（未招募）1 期
Discontinuation of imatinib in patients with oligo-metastatic gastrointestinal stromal tumor that has become radiologically undetectable with treatment - The stop-GIST trial
Oslo University Hospital0 个研究点目标入组 31 人开始时间: 2017年5月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 31
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
- •1. Age = 18.
- •2. Morphological and immunohistochemical documentation of GIST (immunostaining for KIT/(CD117) and/or DOG-1 (anoctamin-1)) must be positive on a tumour sample. Patients with demonstrated mutation in KIT or PDGFRA may be entered to the study despite negative immunostaining for KIT and DOG-1 provided that tumour histology is compatible with GIST.
- •3. >5.0 years of treatment with imatinib for metastatic disease when the breaks in imatinib administration are taken into account.
- •4. No more than 3 detectable metastases in the liver and/or in the abdomen in imaging of the abdomen and the pelvis during the course of the disease or at surgery.
- •5. Confirmed metastatic GIST in history by radiology, histology, or both.
- •6. Macroscopically complete resection of all metastases (either R0 or R1 surgery). Patients who have microscopically infiltrated margins (or suspected microscopical infiltration, R1) are allowed to enter the study. RFA of liver metastasis is allowed in place of surgery. Patients whose oligometastatic disease had disappeared completely so that no remaining target lesion for surgery or RFA can be identified (including absence of residual cyst-like lesions) are allowed to enter the study.
- •7. Eastern Co-operative Oncology Group (ECOG) performance status = 2.
- •8. Patient has provided a written, voluntary informed consent prior to study entry and any study-specific procedures.
- •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 10
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 21
排除标准
- •1. Patients with metastases outside of the abdomen (e.g. in the bones or lungs).
- •2. Not willing to donate tumor tissue and/or blood samples for the molecular studies that aim at predicting of GIST recurrence.
- •3. Presence of an SDH mutation or other evidence for SDH deficiency.
- •4. Presence of neurofibromatosis-1.
- •5. R2 resection of the primary tumor or metastasis.
- •6. Patient with inability to grant reliable informed consent.
- •7. Inability to comply with the scheduled follow-up.
- •8. Progressive disease during imatinib or other systemic treatments for GIST, or before or after surgery/RFA of the metastases.
研究者
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暂停
不适用
SSG XXV: The Stop-GIST Trial; Discontinuation of Imatinib in Patients With Oligo-metastatic GISTGastrointestinal Stromal TumorNCT02924714Oslo University Hospital31