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NCT Number: NCT06668038

Contribution of Multicenter Expertise and Deformable Fusion Software 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Cancerologie de L'Ouest, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multidisciplinary and multicenter validation of re-irradiation with curative intent

Other

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 outcomes

  1. 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.

Secondary outcomes

  1. Late safety of re-irradiation

    Time frame: Up to 24 months

    Frequency of late (> 3 months after re-irradiation) grade ≥ 3 adverse events using NCI-CTCAE v5.0.

  2. Local control rate at 3 months

    Time frame: At 3 months

    Rate of patients without progression in the field of re-irradiation

  3. Local control rate at 6 months

    Time frame: At 6 months

    Rate of patients without progression in the field of re-irradiation

  4. Local control rate at 12 months

    Time frame: At 12 months

    Rate of patients without progression in the field of re-irradiation

  5. Local control rate at 24 months

    Time frame: At 24 months

    Rate of patients without progression in the field of re-irradiation

  6. Time required for fusion and dose summation

    Time frame: Up to 3 months

    Median time for whole process workflow (fusion and dose summation)

  7. Benefit of deformable registration

    Time frame: Up to 3 months

    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

  8. Rate of patients having received the proposed validated dose

    Time frame: Up to 5 months

    Rate of patients who received the re-irradiation dose as validated in multidisciplinary and multicenter meeting

  9. Rate of patients without treatment-related toxicity or local progression or death at 2 years

    Time frame: Up to 24 months

    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

  10. Rate of change in centre practices

    Time frame: Up to 48 months

    Rate of centres in which re-irradiation practices have changed between study beginning and end.

Study contacts

Contact information is provided by the study sponsor or research team.

Marie-Pierre SUNYACH, MD

CONTACT

[email protected]

0426556778 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Registry information

Official study 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

Acronym: ADERE

Important dates

Study start
2024
Primary completion
2027
Study completion
2029
First posted
Oct 31, 2024
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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