Clinical trial NCT06668038: Contribution of Multicenter Expertise and Deformable Fusion Software for Re-irradiations With Curative Intent
Official title: Evaluation of the Contribution of Multicenter Expertise (Radiotherapists and Physicists) and Use of Deformable Fusion Software Allowing the Accumulation of Doses in Equivalent Dose 2 Grays for Re-irradiations With Curative Intent
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Re-irradiation
Radiotherapy
Keywords: Re-irradiation
Radiotherapy
Equivalent dose 2 grays
Feasibility
Cumulative doses
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
First posted: 2024-10-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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:

  * 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Rate of patients for whom the intervention has changed the treatment plan
timeFrame: Up to 3 months
Secondary outcomes:
measure: Late safety of re-irradiation
timeFrame: Up to 24 months
measure: Local control rate at 3 months
timeFrame: At 3 months
measure: Local control rate at 6 months
timeFrame: At 6 months
measure: Local control rate at 12 months
timeFrame: At 12 months
measure: Local control rate at 24 months
timeFrame: At 24 months
measure: Time required for fusion and dose summation
timeFrame: Up to 3 months
measure: Benefit of deformable registration
timeFrame: Up to 3 months
measure: Rate of patients having received the proposed validated dose
timeFrame: Up to 5 months
measure: Rate of patients without treatment-related toxicity or local progression or death at 2 years
timeFrame: Up to 24 months
measure: Rate of change in centre practices
timeFrame: Up to 48 months
Other outcomes:
Locations:
city: Angers
country: France
facility: Institut de Cancerologie de L'Ouest
city: Bourg-en-Bresse
country: France
facility: Ch Bourg En Bresse
city: Dijon
country: France
facility: Centre Georges Francois Leclerc
city: Grenoble
country: France
facility: Chu Grenoble Alpes
city: Lyon
country: France
facility: Centre Leon Berard
city: Marseille
country: France
facility: Aphp Marseille Chu Timone Et Hopital Nord Marseille
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Saint-Herblain
country: France
facility: Institut de Cancerologie de L'Ouest
city: Valence
country: France
facility: Centre Marie Curie
city: Villefranche-sur-Saône
country: France
facility: Centre de Radiotherapie Du Beaujolais
Study officials:
affiliation: Centre Leon Berard
name: Marie-Pierre SUNYACH
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Leon Berard
name: Cécile LAUDE
role: PRINCIPAL_INVESTIGATOR
References: