NCT00168922Unknown2 期
Phase II Study to Determine the Efficacy of Bendamustin (Ribomustin) in Patients With Recurrent Small Cell Bronchial Carcinoma After Cytostatic Polychemotherapy
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Determination of response rate ( CR + PR) after cytostatic therapy with Bendamustin 120mg/m2, day 1+2, repeat d 22
研究概览
简要总结
Determination of response rate Assessment of toxicity and determination of "time to progression"
详细描述
Phase II Study to determine the efficacy of Bendamustin(Ribomustin) in patients with recurrent small cell bronchial carcinoma after cytostatic polychemotherapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histological proven, curative non treatable small lung cell carcinoma
- •Recurrence >8 weeks, > 1 year after 1st line treatment with platin- and etoposide polychemotherapy, without brain metastases
排除标准
- •Brain metastases
- •WHO-PS 3 - 4
结局指标
主要结局
Determination of response rate ( CR + PR) after cytostatic therapy with Bendamustin 120mg/m2, day 1+2, repeat d 22
(primary goal)
次要结局
- Assessment of toxicity, determination of time to progression, for median survival and one-year survival rate,investigation of life quality (secondary goal)
研究者
研究点 (2)
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