NCT02428049

Radiation Pneumonitis After SBRT for NSCLC

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 105 (actual)
• Sponsor: Sykehuset i Vestfold HF · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Lung Cancer
• Radiotherapy
• Lung Function Changes

Interventions

Type	Name	Description
RADIATION	Stereotactic or conventional radiotherapy and chemotherapy in curative intent

Timeline

• Start date: 2013-10-01
• Primary completion: 2018-12-01
• Completion: 2025-12-01
• First posted: 2015-04-28
• Last updated: 2023-01-20

Locations

1 site across 1 country: Norway