NCT00191139已完成2 期
A Randomized Study of Gemcitabine Plus Docetaxel After Cisplatin, Etoposide and Radiation Therapy in Stage III Unresectable NSCLC
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- 2-Year Survival
研究概览
简要总结
To assess the 2 year survival of patients with Stage III unresectable non-small cell lung cancer receiving consolidation gemcitabine or gemcitabine plus docetaxel following concurrent chemotherapy and radiation.
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
- •histologic or cytologic proof of single primary non-small cell lung cancer
- •No prior chemotherapy or radiation therapy
- •no prior malignancy
排除标准
- •pregnancy or breastfeeding
- •serious concomitant systemic disorder
- •unintentional weight loss greater than 10%
研究组 & 干预措施
Gemcitabine
Experimental
干预措施: gemcitabine (Drug)
Gemcitabine
Experimental
干预措施: cisplatin (Drug)
Gemcitabine
Experimental
干预措施: etoposide (Drug)
Gemcitabine
Experimental
干预措施: radiation therapy (Radiation)
Gemcitabine plus Docetaxel
Experimental
干预措施: gemcitabine (Drug)
Gemcitabine plus Docetaxel
Experimental
干预措施: docetaxel (Drug)
Gemcitabine plus Docetaxel
Experimental
干预措施: cisplatin (Drug)
Gemcitabine plus Docetaxel
Experimental
干预措施: etoposide (Drug)
Gemcitabine plus Docetaxel
Experimental
干预措施: radiation therapy (Radiation)
结局指标
主要结局
2-Year Survival
时间窗: 2 years
Percentage of participants alive at 2 years.
次要结局
- Number of Patients With Overall Tumor Response(randomization and every 3 months up to 2 years of post-study followup)
- Progression-Free Survival(baseline to measured progressive disease up to 2057 days)
- Overall Survival(baseline to date of death from any cause up to 2057 days)
- Lung Cancer Symptom Scale (LCSS) Assessment Post-randomization(baseline to 3 months after last dose of study treatment (three 21-day cycles))
研究者
研究点 (1)
Loading locations...
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