NCT00812266终止3 期
Randomized Phase III Trial of Topotecan and Cisplatin Versus Etoposide and Carboplatin in the Treatment of Patients With Previously Untreated Small Cell Lung Cancer and Extensive Disease
Danish Oncological Lung Cancer Group1 个研究点 分布在 1 个国家目标入组 281 人开始时间: 2006年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 281
- 试验地点
- 1
- 主要终点
- 2 years survival
研究概览
简要总结
Randomised trial comparing standard chemotherapy with carboplatin and etoposide with a combination of topotecan and cisplatin in patients with inoperable lung cancer of small cell type.
详细描述
Fase III, multicenter randomised trial comparing up to six cycles of carboplatin and etoposide with up to six cycles of topotecan and cisplatin in patients with extensive stage small cell lung cancer and PS 0-3
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 SCLC
- •Extensive stage
- •No prior chemotherapy
- •WHO PS 0-3
- •Adequate organ function (liver, kidney)
- •Adequate hematology (bone marrow)
- •Informed consent
排除标准
- •Inadequate organ function
- •Uncontrolled infection
- •Concomitant major medical contraindications
研究组 & 干预措施
A
Experimental
Topotecan + cisplatin
干预措施: topotecan + cisplatin (Drug)
B
Active Comparator
Etoposide + carboplatin
干预措施: Etoposide + carboplatin (Drug)
结局指标
主要结局
2 years survival
时间窗: 2 years
次要结局
- Response rates(2 years)
研究者
Seppo W. Langer
MD pHD
Danish Oncological Lung Cancer Group
研究点 (1)
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