Radiation Pneumonitis After SBRT for NSCLC

Active, not recruiting

• Conditions: Lung Cancer; Radiotherapy; Lung Function Changes
• Interventions: Radiation: Stereotactic or conventional radiotherapy and chemotherapy in curative intent

• Registration Number: NCT02428049
• Lead Sponsor: Sykehuset i Vestfold HF

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.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2015-04-15
• Study First Submitted QC: 2015-04-22
• Study First Posted: 2015-04-28
• Primary Completion: 2018-12
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-19
• Last Update Posted: 2023-01-20
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
permanently reduced lung function	2 years

Secondary Outcome Measures

Name	Time	Method
predictive value of pulmonary function tests for the development of a permanent reduction in lung function after curative radiotherapy	2 years

Trial Locations

Locations (1)

Vestfold Hospital Trust; 🇳🇴 Tønsberg, Norway