A Phase III Randomized Study Evaluating Surgery of Residual Disease in Patients With Metastatic Gastro-intestinal Stromal Tumor Responding to Imatinib Mesylate.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
RATIONALE: Surgery may remove residual disease in patients with gastrointestinal stromal tumor that is responding to imatinib mesylate. It is not yet known whether surgery is more effective than continued imatinib mesylate in treating patients with metastatic gastrointestinal stromal tumor.
PURPOSE: This randomized phase III trial is studying giving imatinib mesylate therapy together with surgery to see how well it works compared with imatinib mesylate alone in treating patients with metastatic gastrointestinal stromal tumor that is responding to imatinib mesylate.
详细描述
OBJECTIVES:
Primary
- Evaluate whether surgery of residual disease improves the progression-free survival of patients with metastatic gastrointestinal stromal tumor responding to imatinib mesylate.
Secondary
- Correlate the pharmacokinetics of imatinib mesylate and its metabolites before and after randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
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 undergo surgery of residual disease.
干预措施: therapeutic conventional surgery (Procedure)
Arm II
Patients receive imatinib mesylate therapy according to standard of care.
干预措施: imatinib mesylate (Drug)
结局指标
主要结局
Progression-free survival
次要结局
- Overall survival
- Pathological response to imatinib mesylate according to RECIST criteria
- Rate of complete resection
- Surgical morbidity
- Quality of life as measured by EORTC QLQ-C30