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Lung Function After Curatively Intended Radiotherapy for Non-small-cell Lung Carcinoma, -Changes and Predictive Markers
Aims: 1. Evaluate changes in lung function before and after radiotherapy for patients with NSCLC in stage I-III receiving curatively intended radiotherapy 2. To assess the predictive value of pulmonary function tests for the development of radiation pneumonitis after curative radiotherapy 3. To assess biomarkers in blood samples before, during, and after radiotherapy and correlate to the development of radiation pneumonitis 4. Investigate survival
This prospective longitudinal study planned to include 70 patients with NSCLC in stages I-III who will be its own control group for changes in lung function. It will be included patients destined to have stereotactic or concomitant chemoradiotherapy in curative intent. Follow-up will include a physical examination by a pulmonologist, spirometry, determination of the diffusion capacity for carbon monoxide (DLCO), determination of the total lung capacity (TLC), residual volume (RV) and intrathoracic gas volume (ITGV) by body plethysmography, determination of the partial pressure of carbon dioxide (PaCO2) and oxygen (PaO2) by arterial blood gas analysis, the six-minute walking test, the Clinical COPD questionnaire, X-ray and CT scans and blood sample analysis at baseline, 4 to 6 weeks after treatment, and every 3 months thereafter until 12 months after SBRT. Part of the project is to take blood samples. Specific blood samples will be analyzed to identify biomarkers that could predict the development of radiation-induced lung changes. Unfortunately, fewer patients than planned were included.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Vestfold Hospital Trust
Tønsberg, Norway
Start Date
October 1, 2013
Primary Completion Date
December 1, 2018
Completion Date
December 1, 2025
Last Updated
January 20, 2023
105
ACTUAL participants
Stereotactic or conventional radiotherapy and chemotherapy in curative intent
RADIATION
Lead Sponsor
Sykehuset i Vestfold HF
Collaborators
NCT07486219
NCT07485114
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06498635