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