Status:
UNKNOWN
Research of Biomarkers of Response to Proton Beam Therapy in Pediatric and Adult Patients.
Lead Sponsor:
Centre Leon Berard
Conditions:
Brain Cancer
Meningioma
Eligibility:
All Genders
Brief Summary
This trial is a paucicentric, clinico-biological cohort study with retrospective and prospective enrollment, aiming to identify biomarkers predictive of response to Proton Beam Therapy (PBT) in cancer...
Detailed Description
The proton beam model policy adopted by the American Society of Radiation Oncology (ASTRO) in 2017 supports proton therapy in primary solid neoplasms in children treated with curative intent. To date,...
Eligibility Criteria
Inclusion
- I1 Male or female patients, all ages are eligible.
- I2 Confirmed diagnosis of macroscopic tumor previously treated since 2016 (retrospective cohort) or to be treated (prospective cohort) with PBT including one of the following tumor types:Cohort A : high grade sarcoma ; Cohort B: brain tumors; Cohort C: meningioma.
- I3 Presence of at least one measurable lesion before PBT initiation. Post operative situation is possible providing a measurable macroscopic residue, non candidate to a new surgery before PBT.
- I4 Availability of archival representative formalin-fixed, paraffin-embedded (FFPE) and/or frozen tumor sample, with the corresponding hematoxylin and eosin stained slide and a pathological report, meeting the following quality/quantity control (QC) criteria confirmed by a central pathological review: (this sample will be also used to confirm pathological diagnosis ) : at least 20% of tumor cells and a surface area \> 5mm2 with \> 90μm of depth.
- I5. Performance status before PBT: Lansky Play score for pediatric patients \< 12 years of age ≥ 70%; Karnofsky performance status for pediatric patients ≥ 12 years of age ≥ 70%; PS ECOG for adult patients: 0, 1 or 2.
- I6. For prospective cohort : Life-expectancy before PBT \> 2 years .
- I7. For prospective cohort : Women of child-bearing potential and men must agree to use (must have used for retrospective cohort) adequate contraception during all the radiotherapy procedure
- I8. For alive patients - Written informed consent from patient, parents if applicable/legal representative, before any study-specific screening procedures, and willingness to comply to study visits and procedures.
Exclusion
- E1. Patients previously treated with radiotherapy in the same site (re-irradiation), either with protons or photons
- E2. Pregnant or breast-feeding patients at time of PBT initiation.
Key Trial Info
Start Date :
September 24 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04367779
Start Date
September 24 2020
End Date
June 1 2024
Last Update
September 13 2023
Active Locations (2)
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1
Centre Léon Bérard
Lyon, France, 69008
2
Centre Antoine Lacassagne
Nice, France, 06189