NCT00258739已完成2 期
A Phase II, Randomized Study With Docetaxel-gemcitabine Followed by Radiotherapy vs Concomitant Treatment (Radiotherapy and Carboplatine-docetaxel) Followed by Docetaxel-gemcitabine Versus Docetaxel-gemcitabine Followed by Concomitant Treatment (Radiotherapy and Carboplatine-docetaxel) in Stage III 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
- 发起方
- Sanofi
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Response rate in each arm measured according to RECIST criteria
研究概览
简要总结
Primary objective:
- To classify the 2 study groups, according to the tumoral response.
Secondary objectives:
- To evaluate the percentage of focused control per year.
- To calculate the time until progression.
- To evaluate the safety profile.
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
- •Non small cell lung cancer confirmed by histology or by cytology.
- •IIIB stage, except if existing pleural discharge, upper cava vein syndrome or supraclavicular affectation
- •General stage 0-1 at the ECOG scale
- •Loss of weight less than 5% in the 3 previous months from diagnose.
- •Pulmonary function and gasometry results: FEV1 > 30% or 1 l, DLCO (diffusing capacity of the lung for carbon monoxide) > 30%, PCO2 < 45 mmHg and PO2 > 60 mmHg.
- •Normal medullar function (hemoglobin > 11 g/dl, total WBC > 1,5 x 10^9/l, platelets > 100 x 10^9/l)
- •Appropriate renal and hepatic functions
- •Anticonceptive method
- •Available laboratory test (maximum 1 month before)
- •Exclusion criteria:
- •Pleural discharge, upper cava vein syndrome or supraclavicular affectation.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
Concomitant radiotherapy and carboplatin-docetaxel followed by docetaxel-gemcitabine
干预措施: Docetaxel + carboplatin + radiotherapy + docetaxel + gemcitabine (Drug)
2
Experimental
docetaxel-gemcitabine followed by concomitant radiotherapy with carboplatin-docetaxel
干预措施: Docetaxel + gemcitabine + carboplatin + radiotherapy (Other)
结局指标
主要结局
Response rate in each arm measured according to RECIST criteria
时间窗: Throughout the whole study
次要结局
- Percentage of local-regional control within a year(Throughout the first year)
- Time to progression defined as the period of time elapsed between the randomization date and the progression or death date(Throughout the whole study)
- Toxicity measured by CALGB criteria and RTOG/EORTC criteria(Throughout the whole study)
- Global surveillance measured as the period of time elapsed between randomization and death date.(Throughout the whole study duration)
研究者
研究点 (1)
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