Study Results
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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ACTIVE_NOT_RECRUITING
105 participants
OBSERVATIONAL
2013-10-31
2025-12-31
Brief Summary
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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
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Detailed Description
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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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Study Design
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CASE_ONLY
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
Interventions
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Stereotactic or conventional radiotherapy and chemotherapy in curative intent
Eligibility Criteria
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Inclusion Criteria
* Current lung cancer, not older than 8 weeks
* Received written consent
* Non small cell lung cancer
* Stage IA-IIIA
* Inoperable
Exclusion Criteria
* Operable
* Additional cancer disease
* Small cell lung carcinoma or neuroendocrine lung cancer
18 Years
ALL
No
Sponsors
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Norwegian Radium Hospital
OTHER
Oslo University Hospital
OTHER
Sykehuset i Vestfold HF
OTHER
Responsible Party
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Janna Berg
consultant
Locations
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Vestfold Hospital Trust
Tønsberg, , Norway
Countries
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Other Identifiers
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2013/169
Identifier Type: -
Identifier Source: org_study_id
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