ACTRN12605000712606已完成3 期
Intermediate and high risk localised, completely resected, gastrointestinal stromal tumours (GIST) expressing KIT recepto: a controlled randomised trial on adjuvant Imatinib mesylate (Glivec) versus no further therapy after complete surgery
AGITG0 个研究点目标入组 400 人开始时间: 2005年11月4日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 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
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- ot stated 至 ot stated(—)
- 性别
- All
入选标准
- •Histologically proven diagnosis of GIST (positive for CD117), intermediate or high risk of relapse documented on surgical specimen, surgery performed between 2 weeks and 3 months before treatment start , non evidence of residual macroscopic disease after surgery (R0 or R1 resection only), no prior treatment for GIST (ie. radiotherapy, chemotherapy, molecular targeted therapy, biological therapy), absence of distant metastases, WHO performance status 0-2.
排除标准
- •No exclusion criteria
研究者
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