Contribution of Multicenter Expertise and Deformable Fusion Software for Re-irradiations With Curative Intent
- Conditions
- Re-irradiationRadiotherapy
- Registration Number
- NCT06668038
- Lead Sponsor
- Centre Leon Berard
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Rate of patients for whom the intervention has changed the treatment plan 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 Outcome Measures
Name Time Method Local control rate at 3 months At 3 months Rate of patients without progression in the field of re-irradiation
Local control rate at 6 months At 6 months Rate of patients without progression in the field of re-irradiation
Local control rate at 12 months At 12 months Rate of patients without progression in the field of re-irradiation
Local control rate at 24 months At 24 months Rate of patients without progression in the field of re-irradiation
Time required for fusion and dose summation Up to 3 months Median time for whole process workflow (fusion and dose summation)
Benefit of deformable registration 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
Rate of patients having received the proposed validated dose Up to 5 months Rate of patients who received the re-irradiation dose as validated in multidisciplinary and multicenter meeting
Rate of patients without treatment-related toxicity or local progression or death at 2 years 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
Rate of change in centre practices Up to 48 months Rate of centres in which re-irradiation practices have changed between study beginning and end.
Late safety of re-irradiation Up to 24 months Frequency of late (\> 3 months after re-irradiation) grade ≥ 3 adverse events using NCI-CTCAE v5.0.
Trial Locations
- Locations (9)
Institut de Cancerologie de L'Ouest
🇫🇷Saint-Herblain, France
Ch Bourg En Bresse
🇫🇷Bourg-en-Bresse, France
Centre Georges Francois Leclerc
🇫🇷Dijon, France
Chu Grenoble Alpes
🇫🇷Grenoble, France
Centre Leon Berard
🇫🇷Lyon, France
Aphp Marseille Chu Timone Et Hopital Nord Marseille
🇫🇷Marseille, France
Centre Antoine Lacassagne
🇫🇷Nice, France
Centre Marie Curie
🇫🇷Valence, France
Centre de Radiotherapie Du Beaujolais
🇫🇷Villefranche-sur-Saône, France