Three Modalities of Treatment in Operable and Resectable Stage IIIA (T1-3, N2) NSCLC. Randomized Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- percentage of patients alive and operated on without grade 4 toxicity (except for hematological and N/V toxicities)
研究概览
简要总结
Stage IIIA non-small cell lung cancers comprising a mediastinal ganglionic invasion N2 account for 20 to 30% of the NSCLCs. They are almost always potentially resectable, but the results obtained by surgery alone or surgery followed by chemotherapy (CT) and/or radiotherapy (RT) are insufficient. The neoadjuvant approach was tested, in randomized tests of exclusive CT, or in noncomparative tests of RT-CT.
详细描述
These results justify the choice of the study design currently suggested, testing the preoperative feasibility
- chemotherapy: cisplatin-Gemzar (arm A) or
- chemoradiotherapy: cisplatin-navelbine-radiotherapy (arm B) or Carboplatin-Taxol-radiotherapy (arm C).
The results obtained, in terms of feasibility and toxicity, will make it possible to select the optimal diagrams for a phase III 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Operable and resectable stage IIIA (T1-3, N2) NSCLC
- •World Health Organization (WHO) performance status of 1 or less
排除标准
- •Severe cardiac, respiratory, renal or hepatic failure
研究组 & 干预措施
Carboplatin-Taxol-Radiotherapy
Carboplatin-Taxol-Radiotherapy
干预措施: Carboplatin-Taxol-Radiotherapy (Drug)
Cisplatin-Gemzar
Cisplatin-Gemzar
干预措施: Cisplatin-Gemzar (Drug)
Cisplatin-Navelbine-Radiotherapy
Cisplatin-Navelbine-Radiotherapy
干预措施: Cisplatin-Navelbine-Radiotherapy (Drug)
结局指标
主要结局
percentage of patients alive and operated on without grade 4 toxicity (except for hematological and N/V toxicities)
时间窗: at week 22
次要结局
未报告次要终点