NCT00769782已完成2 期
Phase II Multicenter Clinical Trial on Surgery for Patients With Resectable Hepatic Metastasis From Gastrointestinal Stromal Tumors (GISTs)
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan74 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2008年10月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 74
- 主要终点
- Recurrence-free survival
研究概览
简要总结
RATIONALE: Surgery may be an effective treatment for liver metastasis from a gastrointestinal stromal tumor.
PURPOSE: This phase II trial is studying how well surgery works in treating patients with liver metastasis from a gastrointestinal stromal tumor.
详细描述
OBJECTIVES:
- To evaluate the safety and efficacy of surgery in patients with resectable hepatic metastasis secondary to gastrointestinal stromal tumor.
OUTLINE: This is a multicenter study.
Patients undergo surgical resection of hepatic metastasis.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of gastrointestinal stromal tumor (GIST)
- •Hepatic metastasis meeting the following criteria:
- •Clinically diagnosed as surgically resectable with no macroscopic residual tumor
- •No more than 3 hepatic metastases
- •Synchronous hepatic metastasis allowed provided primary tumor is also resectable
- •Does not require radiofrequency ablation and/or microwave coagulation therapy to control the disease
- •No extrahepatic metastasis
- •No history of GIST recurrence
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-1
- •Leukocyte count ≥ 3,000/μL
- •Neutrophil count ≥ 1,500/μL
- •Hemoglobin ≥ 8.0 g/dL
- •Platelet count ≥ 75,000/μL
- •Total bilirubin ≤ 2.0 mg/dL
- •ALT and AST < 120 IU/L
- •GTP < 210 IU/L
- •Not pregnant
- •No poorly controlled diabetes mellitus
- •No NYHA class III-IV cardiac function
- •No hepatitis B or hepatitis B carriers
- •No other malignancy requiring treatment
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior interventional radiology for metastatic disease
- •No prior or concurrent imatinib mesylate
- •No other concurrent treatment
排除标准
- 未提供
结局指标
主要结局
Recurrence-free survival
时间窗: 7.5 years
Recurrence-free survival is defined as time from date of surgery until date of recurrence or death from any cause, whichever comes first.
次要结局
- Overall survival(7.5 years)
- Histological curative resection(At surgery)
- Types and severities of adverse events(7.5 years)
研究者
研究点 (74)
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