Clinical trial NCT02428049: Radiation Pneumonitis After SBRT for NSCLC
Official title: Lung Function After Curatively Intended Radiotherapy for Non-small-cell Lung Carcinoma, -Changes and Predictive Markers
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lung Cancer
Radiotherapy
Lung Function Changes
Lead sponsor: Sykehuset i Vestfold HF
Sponsor class: OTHER
Collaborators: name: Norwegian Radium Hospital
name: Oslo University Hospital
First posted: 2015-04-28
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: lung cancer patients in stages IA-IIIA

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.

Eligibility criteria: 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

Primary outcomes:
measure: permanently reduced lung function
timeFrame: 2 years
Secondary outcomes:
measure: predictive value of pulmonary function tests for the development of a permanent reduction in lung function after curative radiotherapy
timeFrame: 2 years
Other outcomes:
measure: predictive value of genetic markers for permanently reduced lung function after curative radiotherapy
timeFrame: 2 years
Locations:
city: Tønsberg
country: Norway
facility: Vestfold Hospital Trust
Study officials:
References: