Contribution of Multicenter Expertise and Deformable Fusion Software for Re-irradiations With Curative Intent
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Multidisciplinary and multicenter validation of re-irradiation with curative intent.
- Who it may be relevant to
- Registry conditions: Re-irradiation, Radiotherapy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
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.
Interventions
- 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.
Primary outcome measures
- Rate of patients for whom the intervention has changed the treatment plan [Time frame: Up to 3 months]
Secondary outcome measures (10)
- Late safety of re-irradiation [Time frame: Up to 24 months]
- Local control rate at 3 months [Time frame: At 3 months]
- Local control rate at 6 months [Time frame: At 6 months]
- Local control rate at 12 months [Time frame: At 12 months]
- Local control rate at 24 months [Time frame: At 24 months]
- Time required for fusion and dose summation [Time frame: Up to 3 months]
- Benefit of deformable registration [Time frame: Up to 3 months]
- Rate of patients having received the proposed validated dose [Time frame: 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]
- Rate of change in centre practices [Time frame: Up to 48 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 10 centers
- Institut de Cancerologie de L'Ouest — Angers
- Ch Bourg En Bresse — Bourg-en-Bresse
- Centre Georges Francois Leclerc — Dijon
- Chu Grenoble Alpes — Grenoble
- Centre Leon Berard — Lyon
- Aphp Marseille Chu Timone Et Hopital Nord Marseille — Marseille
- Centre Antoine Lacassagne — Nice
- Institut de Cancerologie de L'Ouest — Saint-Herblain
- … and 2 more centers
Identifiers
NCT: NCT06668038 · ADERE (ET23-390)