EUCTR2004-001810-16-BE
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 surgery
European Organisation for Research and Treatment of Cancer0 个研究点目标入组 900 人2005年8月24日
相关药物GLIVEC
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- European Organisation for Research and Treatment of Cancer
- 入组人数
- 900
- 状态
- 进行中（未招募）
- 最后更新
- 8年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •? Histologically proven diagnosis of GIST, with positive immunostaining for KIT (CD117\)
- •? Risk of relapse documented on the surgical specimen, according to the 2002 Consensus Approach to Diagnosis of GIST (See Appendix H and Ref. 7\), as falling within the high\-risk” category (tumor size \>10 cm; or mitotic rate \>10/50HPF; or tumor size \>5 cm \& mitotic rate \>5/50HPF) or the intermediate\-risk” category (tumor size \<5 cm \& mitotic rate 6\-10/50HPF; or tumor size 5\-10 cm \& mitotic rate \<5/50HPF).
- •? Surgery performed from 2 weeks to 3 months before randomization (patients randomized in the treated arm should start Imatinib mesylate within 3 months of surgery).
- •? Non evidence of residual macroscopic disease after surgery. Patients with R0 or R1 resection are eligible.
- •? Prior surgery is admitted provided it was devoid of eradicative intent (e.g., surgery with a main diagnostic intent, emergency surgery with a symptomatic intent, etc.)
- •? No prior radiation therapy, no prior chemotherapy for GIST, no prior therapy with Imatinib mesylate, or any other molecular targeted or biological therapy.
- •? Absence of distant metastases, including absence of any peritoneal lesion not contiguous to the primary tumor, while regional positive lymph nodes are admitted provided they have been macroscopically excised.
- •? Age \>18 yrs.
- •? WHO PS \= 0\-2 (see Appendix B)
- •? The cardiac ejection function will be assessed at baseline. The choice of the method is left to physician’s discretion (LVEF (MUGA or ECHO), NT\-proBNP….). An ECG must also be performed. No Class 3/4 cardiac problems, as defined by the New York Heart Association Criteria (e.g., congestive heart failure, myocardial infarction within 2 months of study; see Appendix C)
排除标准
- 未提供
结局指标
主要结局
未指定
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进行中（未招募）
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已完成
3 期
Adjuvant GIST TrialACTRN12605000712606AGITG400