Phase III Randomized, Intergroup, International Trial Assessing the Clinical Activity of STI-571 at Two Dose Levels in Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST) Expressing the KIT Receptor Tyrosine Kinase (CD117)
试验速览
- 阶段
- 3 期
- 入组人数
- 946
- 主要终点
- Progression-free survival
研究概览
简要总结
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known which dose of imatinib mesylate is more effective in treating gastrointestinal stromal tumor.
PURPOSE: This randomized phase III trial is studying two different doses of imatinib mesylate to compare how well they work in treating patients with unresectable or metastatic gastrointestinal stromal tumor.
详细描述
OBJECTIVES:
Primary
- To compare outcomes of patients with unresectable or metastatic gastrointestinal stromal tumor that expresses KIT (CD117) treated with low-dose imatinib mesylate vs high-dose imatinib mesylate.
Secondary
- To assess response rates in patients treated with two different doses of imatinib mesylate.
- To assess the toxicities of two different doses of imatinib mesylate in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive low-dose oral imatinib mesylate once daily in the absence of disease progression or unacceptable toxicity.
干预措施: imatinib mesylate (Drug)
Arm II
Patients receive high-dose oral imatinib mesylate twice daily in the absence of disease progression or unacceptable toxicity.
干预措施: imatinib mesylate (Drug)
结局指标
主要结局
Progression-free survival
次要结局
- Toxicity as assessed by NCI CTC v2.0
- Overall survival
- Objective tumor response