A Trial for Surgical Treatment in Patients With Initially Locally Unresectable Advanced GIST Without Metastasis During Therapy With Imatinib
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- progression free survival
研究概览
简要总结
Gastrointestinal stromal tumors (GISTs) are a form of sarcoma and the most common sarcoma tumors of the gastrointestinal tract. The limited clinical experience suggests that GIST patients may benefit from neo-adjuvant therapy from primary GIST. This is a prospective, multicenter, open, observational study in evaluation of safety and efficacy of imatinib compared with that of historical data for locally unresectable advanced GIST without metastasis. The study will include an up to 28-day screening period, followed by receiving imatinib mesylate (400 mg/day) for at least 6-12 months and followed up for 3 years after surgery.
详细描述
Primary Objective
- To observe the safety of imatinib compared with that of historical data for locally unresectable advanced GIST without metastasis.
Secondary Objective
- Progression-free survival (PFS) in resected patients during follow up
- R0 resection rate
- objective response rate, tumor shrinkage rate
- Correlation of mutation status with response
- Correlation of PK with response
- Surgical morbidity and mortality and safety follow up
- Quality of life
- Overall survival (OS)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
结局指标
主要结局
progression free survival
时间窗: five years
Evidence of measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with CT scan.
次要结局
- R0 resection rate(three years)
- Objective response rate, tumor shrinkage rate(three years)
- Surgical morbidity and mortality and safety follow up(five years)
- Correlation of PK with response(three years)
- Overall survival (OS)(five years)
研究者
Chun-Nan Yeh
MD, Associate Professor, Dept. of General Surgery.
Chang Gung Memorial Hospital