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Radiation Pneumonitis After SBRT for NSCLC

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02428049
Enrollment
105
Registered
2015-04-28
Start date
2013-10-31
Completion date
2025-12-31
Last updated
2023-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer, Lung Function Changes, Radiotherapy

Brief 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.

Interventions

RADIATIONStereotactic or conventional radiotherapy and chemotherapy in curative intent

Sponsors

Norwegian Radium Hospital
CollaboratorOTHER
Oslo University Hospital
CollaboratorOTHER
Sykehuset i Vestfold HF
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
permanently reduced lung function2 years

Secondary

MeasureTime frame
predictive value of pulmonary function tests for the development of a permanent reduction in lung function after curative radiotherapy2 years

Other

MeasureTime frame
predictive value of genetic markers for permanently reduced lung function after curative radiotherapy2 years

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026