Radiation Pneumonitis After SBRT for NSCLC

Study Overview
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Brief Summary
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Aims: Evaluate changes in lung function before and after radiotherapy for patients with NSCLC in stage I-III receiving curatively intended radiotherapy To assess the predictive value of pulmonary function tests for the development of radiation pneumonitis after curative radiotherapy To assess biomarkers in blood samples before, during, and after radiotherapy and correlate to the development of radiation pneumonitis Investigate survival

Detailed Description
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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.

Official Title
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Lung Function After Curatively Intended Radiotherapy for Non-small-cell Lung Carcinoma, -Changes and Predictive Markers

Conditions
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Lung Cancer, Radiotherapy, Lung Function Changes

Intervention / Treatment
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* Radiation: Stereotactic or conventional radiotherapy and chemotherapy in curative intent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years old Current lung cancer, not older than 8 weeks Received written consent Non small cell lung cancer Stage IA-IIIA Inoperable Exclusion Criteria: Lack of consent Operable Additional cancer disease Small cell lung carcinoma or neuroendocrine lung cancer

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lung cancer patients<br>Lung cancer patients in stages IA-IIIA destined to have stereotactic radiotherapy or conventional radiotherapy and chemotherapy in curative intent | Radiation: Stereotactic or conventional radiotherapy and chemotherapy in curative intent<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| permanently reduced lung function |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| predictive value of pulmonary function tests for the development of a permanent reduction in lung function after curative radiotherapy |  | 2 years |