NCT00174772已完成2 期
A Two Arm Phase II Study Comparing Docetaxel/Cisplatin Induction Therapy Followed By Concurrent Chemoradiotherapy Versus Concurrent Chemoradiotherapy Followed By Consolidation Docetaxel/Cisplatin in Patients With Locally Advanced Unresectable NSCLC (Stage IIIA-Multiple cN2 or IIIB)
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
- 72
- 试验地点
- 1
- 主要终点
- anti-tumor activity including overall response rate
研究概览
简要总结
Primary Objective:
- To evaluate the toxicity/safety profile of docetaxel/cisplatin induction therapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy followed by consolidation docetaxel/cisplatin in patients with locally advanced unresectable NSCLC (stage IIIA- multiple cN2 or IIIB).
Secondary Objective:
- To estimate efficacy parameters in overall response rate, progression free survival and 1 year survival for each of the two above mentioned arms.
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 75 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
研究组 & 干预措施
B
Experimental
Concurrent chemoradiotherapy followed by consolidation chemotherapy
干预措施: docetaxel and cisplatin + radiotherapy followed by docetaxel and cisplatin (Drug)
A
Experimental
Induction chemotherapy followed by concurrent chemoradiotherapy
干预措施: docetaxel and cisplatin followed by concurrent chemoradiotherapy with docetaxel and cisplatin + radiotherapy (Drug)
结局指标
主要结局
anti-tumor activity including overall response rate
时间窗: assessed at the end of the full course of treatment period
次要结局
- all treatment related acute and chronic toxicity assessed according to the NCI-CTC scale(throughout the study)
- other adverse events not reported in the NCI-CTI scale(throughout the study)
- hematological and non-hematological toxicities(reported for all grades observed during each cycle)
研究者
研究点 (1)
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