Radiation Pneumonitis After SBRT for NSCLC

NCT ID: NCT02428049

Last Updated: 2023-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Lung Cancer Radiotherapy Lung Function Changes

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Lung cancer patients

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

Stereotactic or conventional radiotherapy and chemotherapy in curative intent

Intervention Type RADIATION

Interventions

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Stereotactic or conventional radiotherapy and chemotherapy in curative intent

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Norwegian Radium Hospital

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role collaborator

Sykehuset i Vestfold HF

OTHER

Sponsor Role lead

Responsible Party

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Janna Berg

consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Vestfold Hospital Trust

Tønsberg, , Norway

Site Status

Countries

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Norway

Other Identifiers

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2013/169

Identifier Type: -

Identifier Source: org_study_id

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