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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01112631

Enrollment

293

Registered

2010-04-28

Start date

2003-04-30

Completion date

2007-09-30

Last updated

2011-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer

Keywords

NSCLC,, PORT,, Quality of Life,, Pulmonary function after RT

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).

Countries

Poland

Outcome results