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Clinical Trial NCT06668038 (ADERE) for Re-irradiation, Radiotherapy is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Contribution of Multicenter Expertise and Deformable Fusion Software for Re-irradiations With Curative Intent (ADERE) 100

Not yet recruiting
Clinical Trial NCT06668038 (ADERE) is an interventional study for Re-irradiation, Radiotherapy and is currently not yet recruiting. Enrollment is planned to begin on 1 November 2024 and continue until the study accrues 100 participants. Led by Centre Leon Berard, this study is expected to complete by 1 February 2029. The latest data from ClinicalTrials.gov was last updated on 31 October 2024.
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...
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Detailed Description
Recent clinical data confirm the possibility and clinical benefit of delivering a second irradiation with curative intent even if the commonly accepted maximum doses to OARs had been reached during the first irradiation.

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...

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Official Title

Evaluation of the Contribution of Multicenter Expertise (Radiotherapists and Physicists) and Use of Deformable Fusion Software Allowing the Accumulation of Doses in Equivalent Dose 2 Grays for Re-irradiations With Curative Intent

Conditions
Re-irradiationRadiotherapy
Other Study IDs
  • ADERE
  • ADERE (ET23-390)
NCT ID Number
NCT06668038
Start Date (Actual)
2024-11-01
Last Update Posted
2024-10-31
Completion Date (Estimated)
2029-02-01
Enrollment (Estimated)
100
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Re-irradiation
Radiotherapy
Equivalent dose 2 grays
Feasibility
Cumulative doses
Primary Purpose
Other
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalMultidisciplinary 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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Late safety of re-irradiation
Frequency of late (\> 3 months after re-irradiation) grade ≥ 3 adverse events using NCI-CTCAE v5.0.
Up to 24 months
Local control rate at 3 months
Rate of patients without progression in the field of re-irradiation
At 3 months
Local control rate at 6 months
Rate of patients without progression in the field of re-irradiation
At 6 months
Local control rate at 12 months
Rate of patients without progression in the field of re-irradiation
At 12 months
Local control rate at 24 months
Rate of patients without progression in the field of re-irradiation
At 24 months
Time required for fusion and dose summation
Median time for whole process workflow (fusion and dose summation)
Up to 3 months
Benefit of deformable registration
Rate of patients with major anatomical changes between the 2 irradiations for whom the treatment plan was modified due to deformable registration compared to multiple rigid registrations carried out on different regions of interest
Up to 3 months
Rate of patients having received the proposed validated dose
Rate of patients who received the re-irradiation dose as validated in multidisciplinary and multicenter meeting
Up to 5 months
Rate of patients without treatment-related toxicity or local progression or death at 2 years
Number of patients without treatment-related toxicity ≥ 3 grade (according NCI-CTCAE v5.0) or local progression or death during the 2-year follow-up
Up to 24 months
Rate of change in centre practices
Rate of centres in which re-irradiation practices have changed between study beginning and end.
Up to 48 months
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All

  • 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

  • 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
Centre Leon Berard logoCentre Leon Berard
Study Central Contact
Contact: Marie-Pierre SUNYACH, MD, 0426556778, [email protected]
10 Study Locations in 1 Countries
Institut de Cancerologie de L'Ouest, Angers, 49055, France
Augustin MERVOYER, Contact, [email protected]
Augustin MERVOYER, Principal Investigator
Ch Bourg En Bresse, Bourg-en-Bresse, 01012, France
Vardouhie KARAHISSARLIAN-ROBIN, Contact, [email protected]
Vardouhie KARAHISSARLIAN-ROBIN, Principal Investigator
Centre Georges Francois Leclerc, Dijon, 21069, France
Etienne MARTIN, Contact, [email protected]
Etienne MARTIN, Principal Investigator
Chu Grenoble Alpes, Grenoble, 38043, France
Camille VERRY, Contact, [email protected]
Camille VERRY, Principal Investigator
Centre Leon Berard, Lyon, 69373, France
Marie-Pierre SUNYACH, Contact, [email protected]
Marie-Pierre SUNYACH, Principal Investigator
Line CLAUDE, Sub-Investigator
Isabelle MARTEL, Sub-Investigator
Aphp Marseille Chu Timone Et Hopital Nord Marseille, Marseille, 13005, France
Laeticia PADOVANI, Contact, [email protected]
Laeticia PADOVANI, Principal Investigator
Centre Antoine Lacassagne, Nice, 06189, France
Jérôme DOYEN, Contact, [email protected]
Jérôme DOYEN, Principal Investigator
Institut de Cancerologie de L'Ouest, Saint-Herblain, 44805, France
Augustin MERVOYER, Contact, [email protected]
Augustin MERVOYER, Principal Investigator
Centre Marie Curie, Valence, 26000, France
Jean-Baptiste GUY, Contact, [email protected]
Jean-Baptiste Guy, Principal Investigator
Centre de Radiotherapie Du Beaujolais, Villefranche-sur-Saône, 69655, France
Cécile LAUDE, Contact, [email protected]
Cécile LAUDE, Principal Investigator