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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
  Purpose

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
Non-Small Cell Lung Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Enrollment: 293
Study Start Date: April 2003
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01112631

Locations
Poland
M. Sklodowska-Curie Memorial Cancer Centre
Warsaw, Poland, 02-781
Sponsors and Collaborators
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
Investigators
Principal Investigator: Krzysztof Bujko, Prof. Roentgena 5, 02-781 Warsaw, Poland
  More Information

Publications:
Responsible Party: Prof Krzysztof Bujko, Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology in Warsaw
ClinicalTrials.gov Identifier: NCT01112631     History of Changes
Other Study ID Numbers: LPSG01
Study First Received: April 27, 2010
Last Updated: September 19, 2011
Health Authority: Poland: Ministry of Science and Informatization

Keywords provided by Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology:
NSCLC,
PORT,
Quality of Life,
Pulmonary function after RT

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014