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

Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology (Other)
Overall Status
Completed
CT.gov ID
NCT01112631
Collaborator
Institute of Tuberculosis and Lung Diseases in Warsaw (Other), The Greater Poland Centre of Lung Diseases and Tuberculosis in Poznan (Other), The Greater Poland Cancer Centre (Other), Cancer Centre in Bydgoszcz (Other), Kujawsko-Pomorskie Center of Pulmonology in Bydgoszcz (Other), Specialized Hospital in Zdunowo - Szczecin (Other), Regional Cancer Hospital - Szczecin (Other), Medical University of Gdansk (Other), Holycross Cancer Center in Kielce (Other), Department of Thoracic Surgery - Wrocław (Other), Department of Radiotherapy - Olsztyn (Other), Department of Thoracic Surgery - Łódź (Other), Lower Silesian Oncology Center - Wroclaw (Other), Regional Specialized Hospital -Chęciny, Czerwona Góra (Other), Department of Thoracic Surgery - Otwock (Other), Medical University of Łódź (Other)
293
Enrollment
1
Location
53
Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    293 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    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 Start Date :
    Apr 1, 2003
    Actual Primary Completion Date :
    Sep 1, 2007
    Actual Study Completion Date :
    Sep 1, 2007

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 M. Sklodowska-Curie Memorial Cancer Centre Warsaw Poland 02-781

    Sponsors and Collaborators

    • Maria Sklodowska-Curie National Research 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

    Investigators

    • Principal Investigator: Krzysztof Bujko, Prof., Roentgena 5, 02-781 Warsaw, Poland

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01112631
    Other Study ID Numbers:
    • LPSG01
    First Posted:
    Apr 28, 2010
    Last Update Posted:
    Sep 20, 2011
    Last Verified:
    Apr 1, 2010
    Keywords provided by , ,
    NSCLC,
    PORT,
    Quality of Life,
    Pulmonary function after RT
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung

    Study Results

    No Results Posted as of Sep 20, 2011