Bronchial CancerStereotacticNCT05605236
Stereotactic Margins in Localized Bronchial Cancer (T1/T2a, N0)
An observational study of Bronchial Cancer, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Bronchopulmonary cancer is the first cause of mortality in the world. We want to update the margins used in stereotactic radiotherapy, in the context of localized lung cancer, of non-surgical management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchial Cancer
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 16 Feb 2020to 16 Jul 2022
- 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
- Adult, Older adult
Study population: Major subject (≥18 years old) operated on at HUS for T1/T2a N0 stage lung adenocarcinoma or squamous cell carcinoma before 30/09/2019
Who may be able to join
- Major subject (≥18 years old)
- Subject operated on at HUS for T1/T2a N0 stage lung adenocarcinoma or squamous cell carcinoma before 30/09/2019
- CT scan available on the HUS imaging server or on CD
- Subject who has not expressed opposition to the use of his or her data for research purposes
Who cannot join
- Subject who has expressed opposition to participating in the study
- Impossibility to give the subject informed information (difficulties in understanding the subject, ...)
- Subject under legal protection
- Subject under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
France1 site
Service de chirurgie thoracique - CHU de Strasbourg - France
Strasbourg, 67091
About this study
Bronchopulmonary cancer is the first cause of mortality in the world. We want to update the margins used in stereotactic radiotherapy, in the context of localized lung cancer, of non-surgical management.
The investigators wish to redefine the stereotactic radiotherapy margins according to the histological type in localized non-small cell lung cancer.
Indeed, these criteria were previously defined on a smaller cohort, in the context of 3D radiotherapy (mainly T3, T4 tumors). In addition, the incidence of radiation pneumonitis is highly dependent on the irradiated lung volume, which in turn depends on the CTV margins used.
- Conditions
- Bronchial Cancer
- Keywords
- Bronchial cancer, Bronchopulmonary cancer, Stereotactic radiotherapy, Stereotactic CTV margins, Cell lung cancer, 3D radiotherapy
- Medical subject headings
- Carcinoma, Bronchogenic
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective histological study of tumor cell dissemination around the tumor
Measured: Files analysed retrospectively from January 01, 2009 to December 31, 2019 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start16 Feb 2020
- Primary completion16 May 2022
- Study completion16 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05605236
- Sponsor's protocol ID
- 7460
- Acronym
- Stereotactic
- Status last verified
- Dec 2023
- First submitted
- 28 Oct 2022
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Margins in Localized Bronchial Cancer (T1/T2a, N0)
- ClinicalTrials.gov ID
- NCT05605236
- Acronym / sponsor ID
- Stereotactic / 7460
- Conditions
- Bronchial Cancer
- Keywords
- Bronchial cancer, Bronchopulmonary cancer, Stereotactic radiotherapy, Stereotactic CTV margins, Cell lung cancer, 3D radiotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 16 Feb 2020 (actual)
- Primary completion
- 16 May 2022 (actual)
- Study completion
- 16 Jul 2022 (actual)
- First posted
- 4 Nov 2022 (actual)
- 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.
Bronchopulmonary cancer is the first cause of mortality in the world. We want to update the margins used in stereotactic radiotherapy, in the context of localized lung cancer, of non-surgical management.
The investigators wish to redefine the stereotactic radiotherapy margins according to the histological type in localized non-small cell lung cancer.
Indeed, these criteria were previously defined on a smaller cohort, in the context of 3D radiotherapy (mainly T3, T4 tumors). In addition, the incidence of radiation pneumonitis is highly dependent on the irradiated lung volume, which in turn depends on the CTV margins used.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Major subject (≥18 years old) operated on at HUS for T1/T2a N0 stage lung adenocarcinoma or squamous cell carcinoma before 30/09/2019
Key inclusion criteria (4 listed)
- Major subject (≥18 years old)
- Subject operated on at HUS for T1/T2a N0 stage lung adenocarcinoma or squamous cell carcinoma before 30/09/2019
- CT scan available on the HUS imaging server or on CD
- Subject who has not expressed opposition to the use of his or her data for research purposes
Key exclusion criteria (4 listed)
- Subject who has expressed opposition to participating in the study
- Impossibility to give the subject informed information (difficulties in understanding the subject, ...)
- Subject under legal protection
- Subject under guardianship or curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retrospective histological study of tumor cell dissemination around the tumor
Time frame: Files analysed retrospectively from January 01, 2009 to December 31, 2019 will be examined
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 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 Bronchial Cancer, run by University Hospital, Strasbourg, France at 1 site in France.
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 4 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: finished, as of the sponsor's last update on 14 Dec 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Retrospective histological study of tumor cell dissemination around the tumor (time frame: Files analysed retrospectively from January 01, 2009 to December 31, 2019 will be examined). 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 14 Dec 2023.