Re-irradiation with curative intent guided by multicenter expert review and deformable dose fusion software
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
Run by Centre Leon Berard · NCT06668038 · Data updated 2026-11-12
This study tests whether a standardized, team-based review and dose-summation using deformable fusion software can change treatment plans for adults needing a second, potentially curative radiation course.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Centre Leon Berard Academic / other |
| Locations | 10 sites (Angers and 9 other locations) |
| Status | Recruiting |
| Started | November 15, 2024 |
| Main results expected | February 1, 2027 |
| Study ends | February 1, 2029 |
| Registry record updated | September 15, 2026 |
| Trial ID | NCT06668038 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with a planned re-irradiation to a prior irradiated field, meeting criteria for curative intent (e.g., oligo-metastases, second cancer, or local recurrence) and adequate life expectancy.
✕Probably not a fit
Patients with non-eligible sites, multi-metastatic disease, poor performance status, or contraindications to re-irradiation are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The trial evaluates a standardized process in which radiation specialists and physicists review re-irradiation indications and cumulatively sum prior doses using MiM software to calculate EQD2. If the collective assessment suggests curative re-irradiation is feasible, a second course is planned with collected imaging and dosimetry for multidisciplinary validation. The primary goal is to determine how often this process alters the initial treatment plan. Re-irradiation with curative intent is considered even when previous dose limits might have been reached, to enable potentially beneficial outcomes. Eligibility focuses on adults requiring re-irradiation with specific disease scenarios and adequate life expectancy, while excluding certain anatomic sites and higher disease burden.”,
Why it matters
Potential benefit: If successful, the approach could harmonize decision-making and expand access to curative re-irradiation for eligible patients.
How similar studies have gone: Previous data suggest feasibility and potential benefit of second-course radiotherapy, but this specific standardized, software-assisted, multidisciplinary validation approach is novel.
Who can join: the full rules
Show full inclusion / exclusion 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 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
Where it's running
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Ch Bourg En Bresse
Bourg-en-Bresse, France Recruiting -
Centre Leon Berard
Lyon, France Recruiting -
Institut de Cancerologie de L'Ouest
Angers, France Not yet recruiting -
Centre Georges Francois Leclerc
Dijon, France Not yet recruiting -
Chu Grenoble Alpes
Grenoble, France Not yet recruiting -
Aphp Marseille Chu Timone Et Hopital Nord Marseille
Marseille, France Not yet recruiting
Show 4 more locations
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Centre Antoine Lacassagne
Nice, France Not yet recruiting -
Institut de Cancerologie de L'Ouest
Saint-Herblain, France Not yet recruiting -
Centre Marie Curie
Valence, France Not yet recruiting -
Centre de Radiotherapie Du Beaujolais
Villefranche-sur-Saône, France Not yet recruiting
Study contacts
- Principal investigator: Marie-Pierre SUNYACH — Centre Leon Berard
- Study coordinator: Marie-Pierre SUNYACH, MD
- Email: MariePierre.sunyach@lyon.unicancer.fr
- Phone: 0426556778
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.