NCT05605236

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 16, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 4, 2022

Completed
Last Updated

December 14, 2023

Status Verified

December 1, 2023

Enrollment Period

2.2 years

First QC Date

October 28, 2022

Last Update Submit

December 13, 2023

Conditions

Bronchial Cancer

Keywords

Bronchial cancerBronchopulmonary cancerStereotactic radiotherapyStereotactic CTV marginsCell lung cancer3D radiotherapy

Outcome Measures

Primary Outcomes (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

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de chirurgie thoracique - CHU de Strasbourg - France

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Carcinoma, Bronchogenic

Condition Hierarchy (Ancestors)

Bronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2022

First Posted

November 4, 2022

Study Start

February 16, 2020

Primary Completion

May 16, 2022

Study Completion

July 16, 2022

Last Updated

December 14, 2023

Record last verified: 2023-12

Locations

FR(1)