An interventional study of Multidisciplinary and multicenter validation of re-irradiation with curative intent in Re-irradiation and Radiotherapy, sponsored by Centre Leon Berard. Recruiting at 10 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Centre Leon Berard · Not applicable, Interventional, and Other
We propose to evaluate the contribution of a standardized process combining,
The primary objective of this study is to determine the rate of patients for whom this process has changed the treatment plan.
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:
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.
Centre Leon Berard is the lead sponsor of 210 studies on the registry; 62 are open to participants now.
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Re-irradiation with desired curative intent (≥ 50 Gy EQD2), with volume to be irradiated totally or partially included in a previous irradiation field:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: Up to 3 months
Late safety of re-irradiation
Frequency of late (\> 3 months after re-irradiation) grade ≥ 3 adverse events using NCI-CTCAE v5.0.
Time frame: Up to 24 months
Local control rate at 3 months
Rate of patients without progression in the field of re-irradiation
Time frame: At 3 months
Local control rate at 6 months
Rate of patients without progression in the field of re-irradiation
Time frame: At 6 months
Local control rate at 12 months
Rate of patients without progression in the field of re-irradiation
Time frame: At 12 months
Local control rate at 24 months
Rate of patients without progression in the field of re-irradiation
Time frame: At 24 months
Time required for fusion and dose summation
Median time for whole process workflow (fusion and dose summation)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Up to 48 months
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