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

This study has been completed.
Sponsor:
Collaborators:
Institute of Tuberculosis and Lung Diseases in Warsaw
The Greater Poland Centre of Lung Diseases and Tuberculosis in Poznan
The Greater Poland Cancer Centre
Cancer Centre in Bydgoszcz
Kujawsko-Pomorskie Center of Pulmonology in Bydgoszcz
Specialized Hospital in Zdunowo - Szczecin
Regional Cancer Hospital - Szczecin
Medical University of Gdansk
Holycross Cancer Center in Kielce
Department of Thoracic Surgery - Wrocław
Department of Radiotherapy - Olsztyn
Department of Thoracic Surgery - Łódź
Lower Silesian Oncology Center - Wroclaw
Regional Specialized Hospital -Chęciny, Czerwona Góra
Department of Thoracic Surgery - Otwock
Medical University of Łódź
Information provided by:
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
ClinicalTrials.gov Identifier:
NCT01112631
First received: April 27, 2010
Last updated: September 19, 2011
Last verified: April 2010

April 27, 2010
September 19, 2011
April 2003
September 2007   (final data collection date for primary outcome measure)
Pulmonary function [ Time Frame: One month after surgery and two years after postoperative radiotherapy or surgery alone ] [ Designated as safety issue: Yes ]
All patients had pulmonary function tests (PFT) with Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1) recorded.
Same as current
Complete list of historical versions of study NCT01112631 on ClinicalTrials.gov Archive Site
Quality of Life [ Time Frame: One month after surgery and two years after postoperative radiotherapy or surgery alone ] [ Designated as safety issue: Yes ]
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).
Same as current
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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

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

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.

Non-Small Cell Lung Cancer
Not Provided
  • Stage II patients post surgery
    Stage II patients treated with surgery alone
  • Stage III patients post surgery
    Stage III patients treated with surgery and PORT
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. Review. Polish.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
293
September 2007
September 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT01112631
LPSG01
Yes
Prof Krzysztof Bujko, Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology in Warsaw
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
  • Institute of Tuberculosis and Lung Diseases in Warsaw
  • The Greater Poland Centre of Lung Diseases and Tuberculosis in Poznan
  • The Greater Poland Cancer Centre
  • Cancer Centre in Bydgoszcz
  • Kujawsko-Pomorskie Center of Pulmonology in Bydgoszcz
  • Specialized Hospital in Zdunowo - Szczecin
  • Regional Cancer Hospital - Szczecin
  • Medical University of Gdansk
  • Holycross Cancer Center in Kielce
  • Department of Thoracic Surgery - Wrocław
  • Department of Radiotherapy - Olsztyn
  • Department of Thoracic Surgery - Łódź
  • Lower Silesian Oncology Center - Wroclaw
  • Regional Specialized Hospital -Chęciny, Czerwona Góra
  • Department of Thoracic Surgery - Otwock
  • Medical University of Łódź
Principal Investigator: Krzysztof Bujko, Prof. Roentgena 5, 02-781 Warsaw, Poland
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP