Prospective Comparison of Quality of Life and Cardiopulmonary Morbidity After Surgery in Non-small Cell Lung Cancer Patients Treated With and Without Postoperative Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 293
- 试验地点
- 1
- 主要终点
- Pulmonary function
研究概览
简要总结
The patients from 12 centers were included into the study. pN2 patients received PORT, pN1 patients did not. PORT was 3D-planned and consisted in 54-56 Gy in 27-28 fractions. One month after surgery, all patients completed EORTC QLQ C-30 questionnaires and had pulmonary function tests (PFT); cardiopulmonary symptoms were assessed by modified LENT-SOM score. Two years after, all patients free of disease repeated the same examinations. Changes in QLQ, LENT-SOM score and the results of PFT were compared for patients receiving and not PORT.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •complete resection by lobectomy, bi-lobectomy or pneumonectomy of NSCLC,
- •pN1 or pN2 disease,
- •signed informed consent for participation in the study,
- •Karnofsky Performance Status (KPS) higher than 70%.
排除标准
- •presence of distant metastases,
- •N2 diagnosed before surgery in imaging and/or mediastinoscopy,
- •previous radiotherapy to the chest,
- •no or inadequate mediastinal nodal dissection ,
- •FEV1 after surgery lower than 1.0 liter,
- •any active infectious process (including fistula formation) in the chest
结局指标
主要结局
Pulmonary function
时间窗: One month after surgery and two years after postoperative radiotherapy or surgery alone
All patients had pulmonary function tests (PFT) with Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1) recorded.
次要结局
- Quality of Life(One month after surgery and two years after postoperative radiotherapy or surgery alone)