NCT00168883Unknown2 期
Randomized Phase II Study to Determine the Efficacy of a Three Weekly vs. Weekly Therapy With Paclitaxel Plus Carboplatin vs. Paclitaxel Plus Vinorelbine for Patients With Non Small Cell Lung Cancer According to UICC Stage IIIB and IV
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Determination of response rate (stable disease [SD] or better)
研究概览
简要总结
This is a randomized study to assess the efficacy and safety of chemotherapy with platin compared to chemotherapy without platin.
详细描述
Randomized Phase II design, multicenter study, to assess the efficacy and safety of combined chemotherapy with Paclitaxel and Carboplatin versus a platinum free chemotherapy with Paclitaxel and Vinorelbine, within the combination therapies there are two different dosing intervals, which will be assessed as well (4 Arm study).
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
- •Chemotherapy naive patients with histologically confirmed NSCLC stage III and IV
排除标准
- •New York Heart Association (NYHA) III or IV
- •Brain metastases
- •Neurotoxicity Grade 2 or greater
结局指标
主要结局
Determination of response rate (stable disease [SD] or better)
Determination of safety of the combination and life quality
次要结局
- Determination of remission rate
- Determination of time to progression
- Determination of 1-year survival rate
研究者
研究点 (2)
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