Lung CancerNCT02428049
Radiation Pneumonitis After SBRT for NSCLC
An observational study of Lung Cancer and Radiotherapy, run by Sykehuset i Vestfold HF at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Radiotherapy, Lung Function Changes
- What is being tested?
- Stereotactic or conventional radiotherapy and chemotherapy in curative intent
- Type of treatment
- Surgery or procedure
- How many people
- 105 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2013to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: lung cancer patients in stages IA-IIIA
Who may be able to join
- Age > 18 years old
- Current lung cancer, not older than 8 weeks
- Received written consent
- Non small cell lung cancer
- Stage IA-IIIA
- Inoperable
Who cannot join
- Lack of consent
- Operable
- Additional cancer disease
- Small cell lung carcinoma or neuroendocrine lung cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lung Function After Curatively Intended Radiotherapy for Non-small-cell Lung Carcinoma, -Changes and Predictive Markers
Aims:
- Evaluate changes in lung function before and after radiotherapy for patients with NSCLC in stage I-III receiving curatively intended radiotherapy
- To assess the predictive value of pulmonary function tests for the development of radiation pneumonitis after curative radiotherapy
- To assess biomarkers in blood samples before, during, and after radiotherapy and correlate to the development of radiation pneumonitis
- Investigate survival
Read the 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.
- Conditions
- Lung Cancer, Radiotherapy, Lung Function Changes
- Being tested
- Stereotactic or conventional radiotherapy and chemotherapy in curative intent
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic or conventional radiotherapy and chemotherapy in curative intentRadiation
| Study group | Role | What they receive |
|---|---|---|
| Lung cancer patients | Lung cancer patients in stages IA-IIIA destined to have stereotactic radiotherapy or conventional radiotherapy and chemotherapy in curative intent Receives: Radiation: Stereotactic or conventional radiotherapy and chemotherapy in curative intent |
What is being measured
The primary outcome is the main question the study is designed to answer.
permanently reduced lung function
Measured: 2 years
Secondary outcomes (1)
predictive value of pulmonary function tests for the development of a permanent reduction in lung function after curative radiotherapy
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startOct 2013
- Primary completionDec 2018
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset i Vestfold HF
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Radium Hospital, Oslo University Hospital
- Responsible party
- Principal investigator, Janna Berg, Sykehuset i Vestfold HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02428049
- Sponsor's protocol ID
- 2013/169
- Status last verified
- Jan 2023
- First submitted
- 15 Apr 2015
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Function After Curatively Intended Radiotherapy for Non-small-cell Lung Carcinoma, -Changes and Predictive Markers
- ClinicalTrials.gov ID
- NCT02428049
- Acronym / sponsor ID
- 2013/169
- Conditions
- Lung Cancer, Radiotherapy, Lung Function Changes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Sykehuset i Vestfold HFUniversity, hospital or other
- Collaborators
- Norwegian Radium Hospital, Oslo University Hospital
- Study start
- Oct 2013
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 28 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aims:
- Evaluate changes in lung function before and after radiotherapy for patients with NSCLC in stage I-III receiving curatively intended radiotherapy
- To assess the predictive value of pulmonary function tests for the development of radiation pneumonitis after curative radiotherapy
- To assess biomarkers in blood samples before, during, and after radiotherapy and correlate to the development of radiation pneumonitis
- 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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung cancer patients | – | Radiation: Stereotactic or conventional radiotherapy and chemotherapy in curative intentLung cancer patients in stages IA-IIIA destined to have stereotactic radiotherapy or conventional radiotherapy and chemotherapy in curative intent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- lung cancer patients in stages IA-IIIA
Key inclusion criteria (6 listed)
- Age > 18 years old
- Current lung cancer, not older than 8 weeks
- Received written consent
- Non small cell lung cancer
- Stage IA-IIIA
Key exclusion criteria (4 listed)
- Lack of consent
- Operable
- Additional cancer disease
- Small cell lung carcinoma or neuroendocrine lung cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic or conventional radiotherapy and chemotherapy in curative intent | Radiation | Lung cancer patients |
Primary outcome
permanently reduced lung function
Time frame: 2 years
1 secondary outcome
predictive value of pulmonary function tests for the development of a permanent reduction in lung function after curative radiotherapy
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Radiotherapy, run by Sykehuset i Vestfold HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
permanently reduced lung function (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2023.