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

Completed

• Conditions: Non-Small Cell Lung Cancer

• Registration Number: NCT01112631
• Lead Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2010-04
• Study First Submitted: 2010-04-27
• Study First Submitted QC: 2010-04-27
• Study First Posted: 2010-04-28
• Last Update Submitted: 2011-09-19
• Last Update Posted: 2011-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 293

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pulmonary function	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.

Secondary Outcome Measures

Name	Time	Method
Quality of Life	One month after surgery and two years after postoperative radiotherapy or surgery alone	For quality of life assessment, patients were asked to complete the Quality of Life Questionnaire Core 30 Items (QLC-C30) of the European Organization for Research and Treatment of Cancer (EORTC).

Trial Locations

Locations (1)

M. Sklodowska-Curie Memorial Cancer Centre; 🇵🇱 Warsaw, Poland