Multicentric Randomized Phase III Study of Post-Surgical NSCLC Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,775
- 试验地点
- 14
- 主要终点
- Compare overall survival for each arm
研究概览
简要总结
The follow-up of patients operated on for lung cancer is heterogeneous. An intensive follow-up including routine clinic visits, chest X-rays, chest computed tomography (CT) scans and fiberoptic bronchoscopies might detect more small, potentially curable, recurrences and second cancers. However, as it appears in the American Society of Clinical Oncology (ASCO) recommendations, a large randomized study is necessary to evaluate the survival impact of such a follow-up strategy. This is the main objective of this IFCT-0302 study, which is a large randomized controlled study conducted in France comparing this intensive follow-up to a follow-up with only routine clinic visits and chest X-rays.
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
- •completely resected stage I, II, IIIa, and T4 due to satellite tumor nodule(s) N0-2 NSCLC
排除标准
- •stage IIIb to IV NSCLC
结局指标
主要结局
Compare overall survival for each arm
时间窗: 6-month
次要结局
未报告次要终点
