NCT06547710招募中不适用
Primary Tumor Resection for M1a Stage Lung Cancer With Occult Pleural Dissemination Discovered During Surgery: a Prospective, Single-arm, Multi-center, Phase Ⅱ Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Median overall survival
研究概览
简要总结
This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1023. This study aims to explore the safety and efficacy of primary lesion resection in the treatment of M1a stage lung cancer with pleural dissemination found during surgery, and to more accurately evaluate whether primary lesion resection can improve the OS and quality of life of the corresponding patients.
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
- •Volunteer to participate in clinical research, willing to follow and able to complete all trial procedures;
- •Aged 18-80 years (including critical values) when signing the informed consent form;
- •ECOG score 0 or 1;
- •No previous lung cancer surgery;
- •Intraoperative or postoperative pathological confirmation of M1a stage lung cancer;
- •Occult pleural metastasis found during surgery;
- •First-time treatment and no radiotherapy or chemotherapy.
排除标准
- •The lesion cannot be completely removed surgically;
- •Cytological or histological pathology confirms other lung malignancies other than lung cancer;
- •Patients who have undergone lung cancer surgery before;
- •Patients who have received radiotherapy or chemotherapy and are not treatment-naive patients.
结局指标
主要结局
Median overall survival
时间窗: About 10months.
Median overall survival for M1a patients underging surgery.
次要结局
- 2-year overall survival(2 years)
- 5-year overall survival(5 years)
- FEV1 and FVC(0.5 year)
研究者
Haiquan Chen
Director of Thoracic Surgery Department
Fudan University
研究点 (1)
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