Contribution of Multicenter Expertise and Deformable Fusion Software for Re-irradiations With Curative Intent
NCT ID: NCT06668038
Last Updated: 2024-10-31
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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NOT_YET_RECRUITING
NA
100 participants
INTERVENTIONAL
2024-11-01
2029-02-01
Brief Summary
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* a validation of re-irradiation indications by a group of multi-professional experts (radiotherapists and physicists) and,
* a collective validation of the accumulation of doses on all the organs of the anatomical region concerned obtained using deformable fusion software (MiM) allowing the accumulation of doses in terms of Equivalent Dose 2 Grays (EQD2).
The primary objective of this study is to determine the rate of patients for whom this process has changed the treatment plan.
Detailed Description
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However, there is no consensus on acceptable doses to AORs in a re-irradiation context. The difficulty of making decisions and validating dosimetry may limit access to treatment. Re-irradiations are therefore carried out according to local experience and equipment, resulting in territorial inequality.
MiM software is an innovative software dedicated to images registration and dose summation. It allows the EQD2 doses of the various irradiations to be cumulated.
Recruitment and inclusion step: For each included patient (signed consent form), the center provides an initial opinion concerning the indication for re-irradiation with curative intent (Opinion 1).
Indication and pre-dosimetric study step:
* If re-irradiation with curative intent Is not feasible according to the center: timages of the 1st irradiation and recent diagnosis images will be sent to Centre Léon Bérard (CLB), merged into MIM by physicists, and the indication is discussed in a multidisciplinary meeting (Opinion 2).
* If re-irradiation with curative intent is feasible according to the center: CT + RT structures+doses of 1st irradiation and dosimetric scan of the 2nd irradiation will be sent to CLB, merged into MIM. Multidisciplinary meeting will deliver the Opinion 3 with dosimetric instructions for the new irradiation, in particular OARs doses constraints.
Study withdrawal if the indication for re-irradiation is not validated.
Cumulative doses validation step:
CT + RT structures+doses of the planned re-irradiation will be sent to CLB and EQD2 doses will be summed into MIM. If cumulative doses are accepted by consensus, multidisciplinary meeting will deliver the Opinion 4. Otherwise the center will have to do a new planimetry.
Patients for whom re-irradiation with curative intent has been declared possible will be followed for 2 years according to standard practices, approximately every 3 months and analyzed for tolerance and efficiency.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Multidisciplinary and multicenter validation of re-irradiation with curative intent
Validation by a multicenter group of multi-professional experts (radiotherapists and physicists) of:
* re-irradiation indication
* EQD2 cumulated doses using MiM
Multidisciplinary and multicenter validation of re-irradiation with curative intent
Validation in multidisciplinary and multicenter meeting of re-irradiation indication after review of technical data (images, structures and doses) of 1st irradiation and recent diagnosis images of the lesion to be irradiated, merged using MIM.
In case of re-irradiation validation, validation in multidisciplinary and multicenter meeting of cumulated doses after review of EQD2 doses summation using MIM.
Interventions
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Multidisciplinary and multicenter validation of re-irradiation with curative intent
Validation in multidisciplinary and multicenter meeting of re-irradiation indication after review of technical data (images, structures and doses) of 1st irradiation and recent diagnosis images of the lesion to be irradiated, merged using MIM.
In case of re-irradiation validation, validation in multidisciplinary and multicenter meeting of cumulated doses after review of EQD2 doses summation using MIM.
Eligibility Criteria
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Inclusion Criteria
* Re-irradiation with desired curative intent (≥ 50 Gy EQD2), with volume to be irradiated totally or partially included in a previous irradiation field:
* Oligo-metastases or oligo-progression (\< 5 metastases in less than 3 sites)
* Second non-metastatic cancer
* Isolated local recurrence
* Life expectancy \> 6 months
* Dated and signed informed consent
* Affiliation to a social security scheme or equivalent
Exclusion Criteria
* Diagnosis of multi-metastatic cancer
* PS ECOG ≥ 2
* Impossibility to interrupt current treatment with a tyrosine kinase inhibitor or other systemic treatment (excluding hormonal therapy) which may potentiate the rays effects (duration of wash-out according to treatment instructions)
* Pregnant or breastfeeding women
* Tutorship or curatorship or deprivation of liberty
18 Years
ALL
No
Sponsors
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Centre Leon Berard
OTHER
Responsible Party
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Principal Investigators
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Marie-Pierre SUNYACH
Role: PRINCIPAL_INVESTIGATOR
Centre Leon Berard
Cécile LAUDE
Role: PRINCIPAL_INVESTIGATOR
Centre Leon Berard
Locations
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Institut de Cancerologie de L'Ouest
Angers, , France
Ch Bourg En Bresse
Bourg-en-Bresse, , France
Centre Georges Francois Leclerc
Dijon, , France
Chu Grenoble Alpes
Grenoble, , France
Centre Leon Berard
Lyon, , France
Aphp Marseille Chu Timone Et Hopital Nord Marseille
Marseille, , France
Centre Antoine Lacassagne
Nice, , France
Institut de Cancerologie de L'Ouest
Saint-Herblain, , France
Centre Marie Curie
Valence, , France
Centre de Radiotherapie Du Beaujolais
Villefranche-sur-Saône, , France
Countries
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Central Contacts
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Facility Contacts
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Augustin MERVOYER
Role: primary
Vardouhie KARAHISSARLIAN-ROBIN
Role: primary
Etienne MARTIN
Role: primary
Camille VERRY
Role: primary
Marie-Pierre SUNYACH
Role: primary
Laeticia PADOVANI
Role: primary
Jérôme DOYEN
Role: primary
Augustin MERVOYER
Role: primary
Jean-Baptiste GUY
Role: primary
Cécile LAUDE
Role: primary
Other Identifiers
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ADERE (ET23-390)
Identifier Type: -
Identifier Source: org_study_id