Clinical trial Recruiting at 2 sites Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorCentre Leon Berard
Academic / other
Locations10 sites (Angers and 9 other locations)
StatusRecruiting
StartedNovember 15, 2024
Main results expectedFebruary 1, 2027
Study endsFebruary 1, 2029
Registry record updatedSeptember 15, 2026
Trial IDNCT06668038 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.