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Contribution of Multicenter Expertise and Deformable Fusion Software for Re-irradiations With Curative Intent

ConditionsRe-irradiationRadiotherapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Leon Berard

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years when signing the consent form

Oligo-metastases or oligo-progression (< 5 metastases in less than 3 sites)

Second cancer

Isolated local recurrence

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • Multidisciplinary and multicenter validation of re-irradiation with curative intent

    Other intervention

    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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Multidisciplinary and multicenter validation of re-irradiation with curative intentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

Local control rate at 3 months

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

Time frame
At 3 months
3

Local control rate at 6 months

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

Time frame
At 6 months
4

Local control rate at 12 months

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

Time frame
At 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Leon Berard

Lead sponsor

Source ClinicalTrials.gov
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