NCT01125995已完成3 期
A Randomized Phase III Trial for Timing of Radiation in Concurrent Chemoradiation for Limited Stage Small-cell Lung Cancer
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 222
- 试验地点
- 3
- 主要终点
- complete response rate
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and toxicity of different timing of concurrent chemoradiation in the treatment of limited disease status Small-cell lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •histologically confirmed small-cell lung cancer
- •limited disease status
- •with evaluable disease
- •18 years or older
- •ECOG performance status 0,1,2
- •expected survival time should be 12 weeks or longer
- •Adequate organ function as evidenced by the following; Absolute neutrophil count > 1.5 x 109/L; platelets > 100 x 109/L; total bilirubin ≤1.5 UNL; AST and/or ALT < 5 UNL; creatinine clearance ≥ 50mL/min
- •Written informed consent form
排除标准
- •Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia
- •Patients with active infection requiring antibiotics
- •Pregnant or nursing women ( Women of reproductive potential have to agree to use an effective contraceptive method)
- •Prior history of malignancy within 5 years from study entry except for a adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer
- •previous history of chemotherapy or radiotherapy
结局指标
主要结局
complete response rate
时间窗: 6 months
次要结局
- overall survival(36 months)
- objective response rate(6 months)
- Progression-free survival(36 months)
- toxicity by NCI common toxicity version 2.0(36 months)
研究者
Keunchil Park
Professor
Samsung Medical Center
研究点 (3)
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