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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
100
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.
Institut de Cancerologie de L'Ouest
Angers, 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
Institut de Cancerologie de L'Ouest
Saint-Herblain, France
Centre Marie Curie
Valence, France
Centre de Radiotherapie Du Beaujolais
Villefranche-sur-Saône, France
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
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
Local control rate at 3 months
Rate of patients without progression in the field of re-irradiation
Time frame: At 3 months
Local control rate at 6 months
Rate of patients without progression in the field of re-irradiation
Time frame: At 6 months
Local control rate at 12 months
Rate of patients without progression in the field of re-irradiation
Time frame: At 12 months
Local control rate at 24 months
Rate of patients without progression in the field of re-irradiation
Time frame: At 24 months
Time required for fusion and dose summation
Median time for whole process workflow (fusion and dose summation)
Time frame: Up to 3 months
Benefit of deformable registration
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
Time frame: Up to 3 months
Rate of patients having received the proposed validated dose
Rate of patients who received the re-irradiation dose as validated in multidisciplinary and multicenter meeting
Time frame: Up to 5 months
Rate of patients without treatment-related toxicity or local progression or death at 2 years
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
Time frame: Up to 24 months
Rate of change in centre practices
Rate of centres in which re-irradiation practices have changed between study beginning and end.
Time frame: Up to 48 months
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