Active Surveillance for Patients with Multifocal Ground-glass Nodules: a Prospective, Multi-center, Single-arm Trial (ECTOP-1021)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 370
- 试验地点
- 1
- 主要终点
- 5-year overall survival
研究概览
简要总结
This study is a single-arm, multi-center, phase III trial conducted under the Eastern Cooperative Thoracic Oncoloy Project (ECTOP) with the identification number ECTOP-1021. The primary objective of the study is to assess the overall survival of patients with multifocal ground-glass opacities by employing a watchful waiting approach rather than opting for surgical resection.
详细描述
The trial aims to confirm the hypotheses that delaying surgery until GGO nodules exhibit progression or meet certain criteria offers a prognosis equivalent to those undergoing immediate surgical resection, potentially allowing many of these patients to avoid surgery altogether. Surgical criteria are met if any of the lesions exhibit progression (with a maximal diameter increase of more than 1.5mm or the apperance of a solid component) or as determined by each institution.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
结局指标
主要结局
5-year overall survival
时间窗: 5 years
The event is defined as the death due to any causes.
次要结局
未报告次要终点
研究者
Haiquan Chen
Director in the Department of Thoracic Surgery, FUSCC
Fudan University