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We propose to evaluate the contribution of a standardized process combining,
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multidisciplinary and multicenter validation of re-irradiation with curative intent | Experimental | Validation by a multicenter group of multi-professional experts (radiotherapists and physicists) of:
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients for whom the intervention has changed the treatment plan | Defined as the rate of patients for whom:
| Up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Late safety of re-irradiation | Frequency of late (> 3 months after re-irradiation) grade ≥ 3 adverse events using NCI-CTCAE v5.0. | Up to 24 months |
| Local control rate at 3 months | Rate of patients without progression in the field of re-irradiation |
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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:
Life expectancy > 6 months
Dated and signed informed consent
Affiliation to a social security scheme or equivalent
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marie-Pierre SUNYACH, MD | Contact | 0426556778 | +33 | MariePierre.sunyach@lyon.unicancer.fr |
| Name | Affiliation | Role |
|---|---|---|
| Marie-Pierre SUNYACH | Centre Leon Berard | Principal Investigator |
| Cécile LAUDE | Centre Leon Berard | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Cancerologie de L'Ouest | Angers | 49055 | France |
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| At 3 months |
| Local control rate at 6 months | Rate of patients without progression in the field of re-irradiation | At 6 months |
| Local control rate at 12 months | Rate of patients without progression in the field of re-irradiation | At 12 months |
| Local control rate at 24 months | Rate of patients without progression in the field of re-irradiation | At 24 months |
| Time required for fusion and dose summation | Median time for whole process workflow (fusion and dose summation) | 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 | 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 | 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 | 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. | Up to 48 months |
| Ch Bourg En Bresse | Bourg-en-Bresse | 01012 | France |
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| Centre Georges Francois Leclerc | Dijon | 21069 | France |
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| Chu Grenoble Alpes | Grenoble | 38043 | France |
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| Centre Leon Berard | Lyon | 69373 | France |
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| Aphp Marseille Chu Timone Et Hopital Nord Marseille | Marseille | 13005 | France |
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| Centre Antoine Lacassagne | Nice | 06189 | France |
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| Institut de Cancerologie de L'Ouest | Saint-Herblain | 44805 | France |
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| Centre Marie Curie | Valence | 26000 | France |
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| Centre de Radiotherapie Du Beaujolais | Villefranche-sur-Saône | 69655 | France |
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