NCT00171977已完成4 期
Post-Marketing Clinical Study of Postoperative Adjuvant Therapy With Imatinib Mesylate in Patients With Gastrointestinal Stromal Tumors (GIST)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- To evaluate the relapse-free survival (RFS) in patients receiving postoperative adjuvant therapy
研究概览
简要总结
This is a multicenter, post-marketing, clinical study evaluating the safety and efficacy of postoperative adjuvant therapy with Imatinib Mesylate in high-risk patients after curative resection of newly diagnosed GIST.Patients will be evaluated for relapse -free survival as measured by the confirmation of tumor recurrence and survival for 3 years after surgery for their primary tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •underwent macroscopically curative resection;
- •immunohistochemically confirmed KIT (CD117)-positive tumors;
- •judged as being high-risk according to the criteria for risk classification
排除标准
- •synchronous double cancer or metachronous double cancer with a disease-free period of ≤5 years;
- •received therapy with Imatinib Mesylate prior to study entry;
- •cardiac problem of Grade 3 or higher (New York Heart Association (NYHA) criteria)
- •Other protocol-defined inclusion / exclusion criteria may apply.
研究组 & 干预措施
Imatinib Mesylate
Experimental
400 mg once per day
干预措施: Imatinib Mesylate (Drug)
结局指标
主要结局
To evaluate the relapse-free survival (RFS) in patients receiving postoperative adjuvant therapy
时间窗: 3 years
次要结局
- To evaluate overall survival, relapse free(3 years)
- Safety(3 years)
研究者
研究点 (1)
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