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:
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
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
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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
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 Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013