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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

M. Sklodowska-Curie Memorial Cancer Centre

Warsaw, 02-781, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Pulmonary function

Time frame: 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 outcomes

Quality of Life

Time frame: 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).

Sponsors and collaborators

Lead sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Other

Collaborators

Cancer Centre in Bydgoszcz
Department of Radiotherapy - Olsztyn
Department of Thoracic Surgery - Otwock
Department of Thoracic Surgery - Wrocław
Department of Thoracic Surgery - Łódź
Holycross Cancer Center in Kielce
Institute of Tuberculosis and Lung Diseases in Warsaw
Kujawsko-Pomorskie Center of Pulmonology in Bydgoszcz
Lower Silesian Oncology Center - Wroclaw
Medical University of Gdansk
Medical University of Łódź
Regional Cancer Hospital - Szczecin
Regional Specialized Hospital -Chęciny, Czerwona Góra
Specialized Hospital in Zdunowo - Szczecin
The Greater Poland Cancer Centre
The Greater Poland Centre of Lung Diseases and Tuberculosis in Poznan

Registry information

Official study title

Prospective Comparison of Quality of Life and Cardiopulmonary Morbidity After Surgery in Non-small Cell Lung Cancer Patients Treated With and Without Postoperative Radiotherapy

Important dates

Study start: 2003
Primary completion: 2007
Study completion: 2007
First posted: Apr 28, 2010
Registry last updated: Sep 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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