Radiation Pneumonitis After SBRT for NSCLC

Sykehuset i Vestfold HF

Status: Active, not recruiting

Conditions: Lung Function Changes; Radiotherapy; Lung Cancer

Treatments: Radiation: Stereotactic or conventional radiotherapy and chemotherapy in curative intent

Study type: Observational

Funder types: Other

Identifiers

NCT02428049

2013/169

Details and patient eligibility

About

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

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

105 participants in 1 patient group

Lung cancer patients

Description:

Lung cancer patients in stages IA-IIIA destined to have stereotactic radiotherapy or conventional radiotherapy and chemotherapy in curative intent

Treatment:

Radiation: Stereotactic or conventional radiotherapy and chemotherapy in curative intent