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

Not Applicable
Not yet recruiting
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,
...

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.
...

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
100
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

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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Rate of patients for whom the intervention has changed the treatment planUp 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
NameTimeMethod
Local control rate at 3 monthsAt 3 months

Rate of patients without progression in the field of re-irradiation

Local control rate at 6 monthsAt 6 months

Rate of patients without progression in the field of re-irradiation

Local control rate at 12 monthsAt 12 months

Rate of patients without progression in the field of re-irradiation

Local control rate at 24 monthsAt 24 months

Rate of patients without progression in the field of re-irradiation

Time required for fusion and dose summationUp to 3 months

Median time for whole process workflow (fusion and dose summation)

Benefit of deformable registrationUp 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 doseUp 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 yearsUp 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 practicesUp to 48 months

Rate of centres in which re-irradiation practices have changed between study beginning and end.

Late safety of re-irradiationUp 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

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