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

October 30, 2024 updated by: Centre Leon Berard

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Angers, France, 49055
      • Bourg-en-Bresse, France, 01012
      • Dijon, France, 21069
        • Centre Georges François Leclerc
        • Contact:
        • Principal Investigator:
          • Etienne MARTIN
      • Grenoble, France, 38043
        • Chu Grenoble Alpes
        • Principal Investigator:
          • Camille VERRY
        • Contact:
      • Lyon, France, 69373
        • Centre Leon Berard
        • Contact:
        • Principal Investigator:
          • Marie-Pierre SUNYACH
        • Sub-Investigator:
          • Line CLAUDE
        • Sub-Investigator:
          • Isabelle MARTEL
      • Marseille, France, 13005
        • Aphp Marseille Chu Timone Et Hopital Nord Marseille
        • Contact:
        • Principal Investigator:
          • Laeticia PADOVANI
      • Nice, France, 06189
      • Saint-Herblain, France, 44805
      • Valence, France, 26000
        • Centre Marie Curie
        • Contact:
        • Principal Investigator:
          • Jean-Baptiste Guy
      • Villefranche-sur-Saône, France, 69655

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of patients for whom the intervention has changed the treatment plan
Time Frame: Up to 3 months

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 Measure
Measure Description
Time Frame
Late safety of re-irradiation
Time Frame: Up to 24 months
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
Time Frame: At 3 months
Rate of patients without progression in the field of re-irradiation
At 3 months
Local control rate at 6 months
Time Frame: At 6 months
Rate of patients without progression in the field of re-irradiation
At 6 months
Local control rate at 12 months
Time Frame: At 12 months
Rate of patients without progression in the field of re-irradiation
At 12 months
Local control rate at 24 months
Time Frame: At 24 months
Rate of patients without progression in the field of re-irradiation
At 24 months
Time required for fusion and dose summation
Time Frame: Up to 3 months
Median time for whole process workflow (fusion and dose summation)
Up to 3 months
Benefit of deformable registration
Time Frame: Up to 3 months
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
Time Frame: Up to 5 months
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
Time Frame: Up to 24 months
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
Time Frame: Up to 48 months
Rate of centres in which re-irradiation practices have changed between study beginning and end.
Up to 48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Leon Berard

Investigators

  • Principal Investigator: Marie-Pierre SUNYACH, Centre Leon Berard
  • Principal Investigator: Cécile LAUDE, Centre Leon Berard

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2024

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2029

Study Registration Dates

First Submitted

October 30, 2024

First Submitted That Met QC Criteria

October 30, 2024

First Posted (Actual)

October 31, 2024

Study Record Updates

Last Update Posted (Actual)

October 31, 2024

Last Update Submitted That Met QC Criteria

October 30, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ADERE (ET23-390)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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