Re-irradiationADERENCT06668038
Contribution of Multicenter Expertise and Deformable Fusion Software for Re-irradiations With Curative Intent
A study testing Multidisciplinary and multicenter validation of re-irradiation with curative intent in people with Re-irradiation and Radiotherapy, run by Centre Leon Berard at 10 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Re-irradiation, Radiotherapy
- What is being tested?
- Multidisciplinary and multicenter validation of re-irradiation with curative intent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 10 sitesFrance
- Study dates
- 15 Nov 2024to 1 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 cancer
- Isolated local recurrence
- Life expectancy > 6 months
- Dated and signed informed consent
- Affiliation to a social security scheme or equivalent
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
France10 sites, 10 recruiting
- Not yet recruiting
Institut de Cancerologie de L'Ouest
Angers, 49055
Augustin MERVOYER, augustin.mervoyer@ico.unicancer.fr
Augustin MERVOYER
- Recruiting
Ch Bourg En Bresse
Bourg-en-Bresse, 01012
Vardouhie KARAHISSARLIAN-ROBIN, vkarahissarlianrobin@ch-bourg01.fr
Vardouhie KARAHISSARLIAN-ROBIN
- Not yet recruiting
Centre Georges Francois Leclerc
Dijon, 21069
Etienne MARTIN, emartin@cgfl.fr
Etienne MARTIN
- Not yet recruiting
Chu Grenoble Alpes
Grenoble, 38043
Camille VERRY, cverry@chu-grenoble.fr
Camille VERRY
- Recruiting
Centre Leon Berard
Lyon, 69373
Marie-Pierre SUNYACH, mariepierre.sunyach@lyon.unicancer.fr
Marie-Pierre SUNYACH
- Not yet recruiting
Aphp Marseille Chu Timone Et Hopital Nord Marseille
Marseille, 13005
Laeticia PADOVANI, laeticia.padovani@ap-hm.fr
Laeticia PADOVANI
- Not yet recruiting
Centre Antoine Lacassagne
Nice, 06189
Jérôme DOYEN, jerome.doyen@nice.unicancer.fr
Jérôme DOYEN
- Not yet recruiting
Institut de Cancerologie de L'Ouest
Saint-Herblain, 44805
Augustin MERVOYER, augustin.mervoyer@ico.unicancer.fr
Augustin MERVOYER
- Not yet recruiting
Centre Marie Curie
Valence, 26000
Jean-Baptiste GUY, dr.guy@cmc-valence.org
Jean-Baptiste Guy
- Not yet recruiting
Centre de Radiotherapie Du Beaujolais
Villefranche-sur-Saône, 69655
Cécile LAUDE, cecile.laude@lyon.unicancer.fr
Cécile LAUDE
About this study
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
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.
Read the 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.
- Conditions
- Re-irradiation, Radiotherapy
- Being tested
- Multidisciplinary and multicenter validation of re-irradiation with curative intent
- Keywords
- Re-irradiation, Radiotherapy, Equivalent dose 2 grays, Feasibility, Cumulative doses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary and multicenter validation of re-irradiation with curative intentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Multidisciplinary and multicenter validation of re-irradiation with curative intent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 months
Secondary outcomes (10)
Late safety of re-irradiation
Frequency of late (> 3 months after re-irradiation) grade ≥ 3 adverse events using NCI-CTCAE v5.0.
Measured: Up to 24 months
Local control rate at 3 months
Rate of patients without progression in the field of re-irradiation
Measured: At 3 months
Local control rate at 6 months
Rate of patients without progression in the field of re-irradiation
Measured: At 6 months
Local control rate at 12 months
Rate of patients without progression in the field of re-irradiation
Measured: At 12 months
Local control rate at 24 months
Rate of patients without progression in the field of re-irradiation
Measured: At 24 months
Time required for fusion and dose summation
Median time for whole process workflow (fusion and dose summation)
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start15 Nov 2024
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Re-irradiationStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Pierre SUNYACH, Principal investigator, Centre Leon BerardCécile LAUDE, Principal investigator, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06668038
- Sponsor's protocol ID
- ADERE (ET23-390)
- Acronym
- ADERE
- Status last verified
- Sep 2026
- First submitted
- 30 Oct 2024
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06668038
- Acronym / sponsor ID
- ADERE / ADERE (ET23-390)
- Conditions
- Re-irradiation, Radiotherapy
- Keywords
- Re-irradiation, Radiotherapy, Equivalent dose 2 grays, Feasibility, Cumulative doses
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 31 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multidisciplinary and multicenter validation of re-irradiation with curative intent | Experimental | Other: Multidisciplinary and multicenter validation of re-irradiation with curative intentValidation by a multicenter group of multi-professional experts (radiotherapists and physicists) of: * re-irradiation indication * EQD2 cumulated doses using MiM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- Life expectancy > 6 months
- Dated and signed informed consent
- Affiliation to a social security scheme or equivalent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidisciplinary and multicenter validation of re-irradiation with curative intentValidation 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. | Other | Multidisciplinary and multicenter validation of re-irradiation with curative intent |
Primary outcome
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.
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marie-Pierre SUNYACH principal investigator
Centre Leon Berard
Cécile LAUDE principal investigator
Centre Leon Berard
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary and multicenter validation of re-irradiation with curative intent in people with Re-irradiation and Radiotherapy, run by Centre Leon Berard at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie-Pierre SUNYACH, MD (0426556778 ext. +33, MariePierre.sunyach@lyon.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients for whom the intervention has changed the treatment plan (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.