Clinical trial NCT01112631: Prospective Study of Quality of Life in Non-small Cell Lung Cancer (NSCLC) Patients Treated With/Without Postoperative Radiotherapy
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Small Cell Lung Cancer
Keywords: NSCLC,
PORT,
Quality of Life,
Pulmonary function after RT
Lead sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
Sponsor class: OTHER
Collaborators: name: Institute of Tuberculosis and Lung Diseases in Warsaw
name: The Greater Poland Centre of Lung Diseases and Tuberculosis in Poznan
name: The Greater Poland Cancer Centre
name: Cancer Centre in Bydgoszcz
name: Kujawsko-Pomorskie Center of Pulmonology in Bydgoszcz
name: Specialized Hospital in Zdunowo - Szczecin
name: Regional Cancer Hospital - Szczecin
name: Medical University of Gdansk
name: Holycross Cancer Center in Kielce
name: Department of Thoracic Surgery - Wrocław
name: Department of Radiotherapy - Olsztyn
name: Department of Thoracic Surgery - Łódź
name: Lower Silesian Oncology Center - Wroclaw
name: Regional Specialized Hospital -Chęciny, Czerwona Góra
name: Department of Thoracic Surgery - Otwock
name: Medical University of Łódź
First posted: 2010-04-28
Enrollment: 293
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: It was assessed that during planned 3 years of accrual approximately 360 stage II patients treated with surgery alone and approximately 240 stage III patients treated with surgery and postoperative radiotherapy (PORT) would enter the study.The higher number of inclusions of pN1 was planned, because of expected higher percentage of cancer related deaths within two years in pN2 patients.

Patients with pN1 disease were followed in the thoracic surgery center and had no PORT. Patients with pN2 disease were referred to PORT.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pulmonary function
timeFrame: One month after surgery and two years after postoperative radiotherapy or surgery alone
Secondary outcomes:
measure: Quality of Life
timeFrame: One month after surgery and two years after postoperative radiotherapy or surgery alone
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: M. Sklodowska-Curie Memorial Cancer Centre
Study officials:
affiliation: Roentgena 5, 02-781 Warsaw, Poland
name: Krzysztof Bujko, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kepka 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.