Prospective Study of Quality of Life in Non-small Cell Lung Cancer (NSCLC) Patients Treated With/Without Postoperative Radiotherapy
September 19, 2011 updated by: Maria Sklodowska-Curie National Research Institute of Oncology
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
293
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Warsaw, Poland, 02-781
- M. Sklodowska-Curie Memorial Cancer Centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Stage II patients post surgery
Stage II patients treated with surgery alone
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Stage III patients post surgery
Stage III patients treated with surgery and PORT
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pulmonary function
Time Frame: One month after surgery and two years after postoperative radiotherapy or surgery alone
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All patients had pulmonary function tests (PFT) with Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1) recorded.
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One month after surgery and two years after postoperative radiotherapy or surgery alone
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Quality of Life
Time Frame: One month after surgery and two years after postoperative radiotherapy or surgery alone
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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).
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One month after surgery and two years after postoperative radiotherapy or surgery alone
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2003
Primary Completion (Actual)
September 1, 2007
Study Completion (Actual)
September 1, 2007
Study Registration Dates
First Submitted
April 27, 2010
First Submitted That Met QC Criteria
April 27, 2010
First Posted (Estimate)
April 28, 2010
Study Record Updates
Last Update Posted (Estimate)
September 20, 2011
Last Update Submitted That Met QC Criteria
September 19, 2011
Last Verified
April 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LPSG01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.