Multicentric Retrospective Observation Study: Neoadjuvant Treatment and Surgery Versus Definitive Chemoradiation in the Non-Small Cell Lung Cancer (NSCLC) IIIA-N2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 294
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
The objective of this multicenter retrospective study is to compare overall survival in patients with stage IIIA-N2 NSCLC treated with neoadjuvant treatment and surgery versus definitive chemoradiation.
Secondary objectives are to analyze disease-free survival, median survival, locoregional and distant relapses as well as mortality and toxicity related to treatment.
详细描述
Based on data published by the Intergroup 0139 trial, induction therapy followed by surgery in patients with stage IIIA-N2 NSCLC can increase overall survival compared to exclusive radical chemoradiation treatment.
The major handicap of all studies addressing the role of surgery in IIIA-N2 NSCLC is the difficulty of recruiting patients. Therefore, multicenter studies are necessary to confirm the hypothesis generated by the INT 0139.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage IIIA (N2) disease
- •Potentially resectable disease
- •Stage Lung Cancer with CT scan or PET-CT.
- •N2 involvement: it is not necessary pathological proof.
- •No progression after induction treatment.
排除标准
- •T4 or N3 stage.
- •Bulky disease or not resectable.
结局指标
主要结局
Overall survival
时间窗: 5 years
次要结局
- Disease-free survival(5 years)
- Patterns of Relapse(5 years)
- Mortality(5 years)
研究者
Felipe Couñago
Doctor
Grupo de Investigación Clínica en Oncología Radioterapia