Stereotactic Margins in Localized Bronchial Cancer (T1/T2a, N0)

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT05605236
Collaborator
(none)
300
1
34.5
8.7

Study Details

Study Description

Brief 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.

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Stereotactic Margins in Localized Bronchial Cancer (T1/T2a, N0)
    Actual Study Start Date :
    Feb 16, 2020
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Retrospective histological study of tumor cell dissemination around the tumor [Files analysed retrospectively from January 01, 2009 to December 31, 2019 will be examined]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion criteria:
    • 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

    Exclusion Criteria:
    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service de chirurgie thoracique - CHU de Strasbourg - France Strasbourg France 67091

    Sponsors and Collaborators

    • University Hospital, Strasbourg, France

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Strasbourg, France
    ClinicalTrials.gov Identifier:
    NCT05605236
    Other Study ID Numbers:
    • 7460
    First Posted:
    Nov 4, 2022
    Last Update Posted:
    Nov 4, 2022
    Last Verified:
    Oct 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Strasbourg, France
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 4, 2022