Chang Gung Memorial Hospital, Chang Gung University, College of Medicine, Taipei, Taiwan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 179
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
Docetaxel and pemetrexed have been validated for previously treated advanced non-small cell lung cancer (NSCLC); however, tolerability is a concern with the docetaxel (tri-weekly 75 mg/m2 schedule). The investigators conducted this study to compare the efficacy and toxicity of weekly low-dose docetaxel versus tri-weekly pemetrexed for previously treated advanced NSCLC.
详细描述
We have been following a schedule of weekly low dose docetaxel (30 mg/m2 on days 1 and 8 every 3 weeks; 60 mg/m2 accumulated dose for each cycle) at our hospital in an effort to achieve better tolerability. We therefore performed an exploratory study, by statistical analyses, to investigate the efficacy and toxicity of such a low dose docetaxel schedule compared to that of pemetrexed in patients with NSCLC who have failed previous chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •stage IIIb or IV NSCLC
- •previous treatment with chemotherapy or tyrosin kinase inhibitor
- •performance status less than 2
排除标准
- •age less 18 years
- •pregnancy
- •performance status 3-4
研究组 & 干预措施
low dose docetaxel
Low dose single docetaxel (30 mg/m2 on days 1 and 8 every 3 weeks)
干预措施: docetaxel (Drug)
Pemetrexed
Pemetrexed (500 mg/m2 every 3 weeks)
干预措施: pemetrexed (Drug)
结局指标
主要结局
Objective response rate
时间窗: at least 3 cycles
次要结局
- PFS-progression free survival(the time from the first cycle of chemotherapy to documented progression, or death from any cause)
- OS-overall survival(from the start date of the treatment to death or to the last follow-up visit)