Clinical trial · Observational
Prospective Study of Quality of Life in Non-small Cell Lung Cancer (NSCLC) Patients Treated With/Without Postoperative Radiotherapy
Prospective Comparison of Quality of Life and Cardiopulmonary Morbidity After Surgery in Non-small Cell Lung Cancer Patients Treated With and Without Postoperative Radiotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Stage II patients post surgery
- description
- Stage II patients treated with surgery alone
- label
- Stage III patients post surgery
- description
- Stage III patients treated with surgery and PORT
Primary outcomes (1)
- measure
- Pulmonary function
- timeFrame
- One month after surgery and two years after postoperative radiotherapy or surgery alone
- description
- All patients had pulmonary function tests (PFT) with Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1) recorded.
Secondary outcomes (1)
- measure
- Quality of Life
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDKepka L, Bujko K. [Postoperative radiotherapy for non-small cell lung cancer: evidence based data and clinical practice]. Pneumonol Alergol Pol. 2007;75(3):256-61. Polish. PMID 17966101