Contribution of Multicenter Expertise and Deformable Fusion Software for Re-irradiations With Curative Intent

NCT06668038 | Not Yet Recruiting DMC

• 1 other identifier: ADERE (ET23-390)
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 10

Brief Summary

We propose to evaluate the contribution of a standardized process combining,

• 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.

Conditions

Re-irradiation; Radiotherapy

Keywords

Re-irradiation; Radiotherapy; Equivalent dose 2 grays; Feasibility; Cumulative doses

Outcome Measures

Primary Outcomes (1)

• Rate of patients for whom the intervention has changed the treatment plan

  Defined as the rate of patients for whom: * Re-irradiation at curative doses is finally possible while initially deemed unfeasible, * or validated median dose to GTV is increased by at least 5% compared to the initially envisaged dose, * or doses constraints to OARs are modified, * or the envisaged re-irradiation is invalidated.

  Up to 3 months

Secondary Outcomes (10)

• Late safety of re-irradiation

  Up to 24 months

• Local control rate at 3 months

  At 3 months

• Local control rate at 6 months

  At 6 months

• Local control rate at 12 months

  At 12 months

• Local control rate at 24 months

  At 24 months

Study Arms (1)

Multidisciplinary and multicenter validation of re-irradiation with curative intent

EXPERIMENTAL

Validation by a multicenter group of multi-professional experts (radiotherapists and physicists) of: * re-irradiation indication * EQD2 cumulated doses using MiM

Other: Multidisciplinary and multicenter validation of re-irradiation with curative intent

Interventions

Multidisciplinary and multicenter validation of re-irradiation with curative intent OTHER

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.

Multidisciplinary and multicenter validation of re-irradiation with curative intent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years when signing the consent form
• 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

You may not qualify if:

• Indication of intracranial, prostate, rectum or esophagus re-irradiation
• 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

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (10)

Institut de Cancerologie de L'Ouest

Angers, 49055, France

Location

Ch Bourg En Bresse

Bourg-en-Bresse, 01012, France

Location

Centre Georges Francois Leclerc

Dijon, 21069, France

Location

Chu Grenoble Alpes

Grenoble, 38043, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Aphp Marseille Chu Timone Et Hopital Nord Marseille

Marseille, 13005, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Institut de Cancerologie de L'Ouest

Saint-Herblain, 44805, France

Location

Centre Marie Curie

Valence, 26000, France

Location

Centre de Radiotherapie Du Beaujolais

Villefranche-sur-Saône, 69655, France

Location

Study Officials

• Marie-Pierre SUNYACH

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

• Cécile LAUDE

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Pierre SUNYACH, MD

CONTACT

0426556778; MariePierre.sunyach@lyon.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: October 31, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2029
• Last Updated: October 31, 2024

Record last verified: 2024-10

Locations

FR (10)