Radiation Pneumonitis After SBRT for NSCLC

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02428049
• Other study ID #: 2013/169
• Status: Active, not recruiting
• Start date: October 2013
• Est. completion date: December 2025

Study information

• Verified date: January 2023
• Source: Sykehuset i Vestfold HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 105
• Est. completion date: December 2025
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Function Changes
• Radiotherapy

Intervention

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

Locations

Country	Name	City	State
Norway	Vestfold Hospital Trust	Tønsberg

Sponsors (3)

Lead Sponsor	Collaborator
Sykehuset i Vestfold HF	Norwegian Radium Hospital, Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	predictive value of genetic markers for permanently reduced lung function after curative radiotherapy		2 years
Primary	permanently reduced lung function		2 years
Secondary	predictive value of pulmonary function tests for the development of a permanent reduction in lung function after curative radiotherapy		2 years