Prospective Study of Quality of Life in Non-small Cell Lung Cancer (NSCLC) Patients Treated With/Without Postoperative Radiotherapy

Maria Sklodowska-Curie National Research Institute of Oncology

Status: Completed

Conditions: Non-Small Cell Lung Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT01112631

LPSG01

Details and patient eligibility

About

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.

Enrollment: 293 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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%.

Exclusion criteria

• 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

Trial design

293 participants in 2 patient groups

Stage II patients post surgery

Description:

Stage II patients treated with surgery alone

Stage III patients post surgery

Description:

Stage III patients treated with surgery and PORT