NCT00191490已完成2 期
A Multicenter Randomized Phase II Study Evaluating the Feasibility and Activity of Two Different Combinations of Docetaxel (RP56976, TAXOTERE *) and Gemcitabine and of Cisplatin/Gemcitabine Followed by Docetaxel as First Line Therapy for Locally Advanced Unresectable or Metastatic Non Small Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 2
- 主要终点
- To assess the antitumour activity as measured by response rate in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) of two different combinations of docetaxel and gemcitabine and of a sequential treatment of
研究概览
简要总结
Phase II study that will evaluate the activity of gemcitabine as intravesical therapy on the marker lesion in superficial bladder carcinoma at intermediate risk. Primary objective is the evaluation of the pathological complete response after 8 instillation of gemcitabine. 46 patients are requested.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
To assess the antitumour activity as measured by response rate in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) of two different combinations of docetaxel and gemcitabine and of a sequential treatment of
cisplatin /gemcitabine
次要结局
- To determine time to progression, duration of response, time to treatment failure, and overall survival in each group.
- To evaluate changes from baseline in the Lung Cancer Symptom Scale of patients in each treatment arm
研究者
研究点 (2)
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