Perioperative Imatinib Mesylate in Treating Patients With Locally Advanced Gastrointestinal Stromal Tumor
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Rate of disease recurrence at 2 years
研究概览
简要总结
Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Perioperative imatinib mesylate may shrink the tumor and may reduce the chance of relapse after surgery. This phase II trial is studying the effectiveness of perioperative imatinib mesylate in treating patients with locally advanced gastrointestinal stromal tumor.
详细描述
Open-label trial in patients with locally advanced GISTs admitted to Department of Surgery, Beijing Cancer Hospital and Institute between April 2010 and May 2013 was carried out prospectively. Patients were planned to be treated with imatinib for duration of 6 months followed by surgical resection. Postoperative imatinib was planned to be administrated for 1.5 years. The primary end point was recurrent free survival (RFS) at 2 years; the secondary end points included objective response rate (ORR), surgical outcomes and drug safety.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed gastrointestinal stromal tumor
- •Locally advanced disease: tumour size >5 cm and mitotic count >5/HPF; tumour size >10 cm; mitotic count >10/HPF
- •Potentially resectable disease: Multivisceral resection may be necessary to get sufficient margins
- •Documented c-kit (CD117) expression by immunohistochemical analysis of either initial core specimen or, if recurrent disease, from original tumor block
- •At least 1 site of measurable disease
- •No known brain metastases
- •PATIENT CHARACTERISTICS:
- •Age:18 and over Performance status:ECOG 0-3 Life expectancy:Not specified
- •Platelet count > 100,000/mm3
- •Absolute neutrophil count > 1,500/mm3 Hepatic
- •AST and ALT < 2.5 times upper limits of normal (ULN) (5 times ULN if hepatic metastases are present)
- •Bilirubin < 1.5 times ULN
- •No chronic active hepatitis
- •No cirrhosis
- •No other chronic liver disease Renal
- •Creatinine < 1.5 times ULN
- •No chronic renal disease Cardiovascular
- •No New York Heart Association class III-IV cardiac disease
- •No congestive heart failure
- •No myocardial infarction within the past 6 months Immunology
- •No active uncontrolled infection
- •No known HIV positivity Other
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment
- •Must be medically fit to undergo surgery
- •No other primary malignancy within the past 5 years except basal cell skin cancer, carcinoma in situ of the cervix, or a primary malignancy that is not currently clinically significant and does not require active intervention
- •No gastrointestinal obstruction or major bleeding episode requiring immediate surgical intervention
- •No uncontrolled diabetes
- •No other severe or uncontrolled medical disease
- •No significant history of noncompliance to medical regimens
- •PRIOR CONCURRENT THERAPY:
- •No concurrent anticancer biologic agents
- •More than 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) unless disease is rapidly progressing
- •No concurrent anticancer chemotherapy
- •At least 28 days since prior radiotherapy
- •More than 2 weeks since prior major surgery except tumor biopsy Other
- •At least 28 days since prior investigational drugs
- •At least 28 days since prior imatinib mesylate
- •No concurrent therapeutic doses of warfarin
- •Concurrent low-molecular weight heparin or mini-dose warfarin (1 mg per day) prophylaxis is allowed
排除标准
- 未提供
结局指标
主要结局
Rate of disease recurrence at 2 years
时间窗: 4 years
次要结局
- Rates of objective response (complete, partial, and stable)(2 years)
- Determine the safety and tolerability of this drug in these patients.(3 years)
研究者
Ziyu Li
vice director of Department of Gastrointestinal Surgery，Peking University Cancer Hospital and Institute
Peking University