NCT00286169终止3 期
Randomized Phase III Trial of Amrubicin Versus Carboplatin Plus Etoposide in Elderly Patients With Extensive-disease Small-cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 130
- 试验地点
- 10
- 主要终点
- Overall survival
研究概览
简要总结
The purpose of this study is to compare the efficacy and toxicity of amrubicin with carboplatin plus etoposide in elderly patients with extensive-disease 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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Extensive-disease small-cell lung cancer
- •Aged 70 years or older
- •Performance status of 0-2
- •No prior chemotherapy
排除标准
- •Prior therapy for primary lesion
- •Pneumonitis and/or pulmonary fibrosis
- •Active concomitant malignancy
结局指标
主要结局
Overall survival
次要结局
- Time to progression
- Objective tumor response
- Frequency and severity of adverse events
- Quality of Life (QOL: EuroQOL, FACT-L-LCS)
研究者
研究点 (10)
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