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Research of Biomarkers of Response to Proton Beam Therapy in Pediatric and Adult Patients. — PROTONBIOMARKS  

Sarcoma Clinical Trial

Official title:
PROTONBIOMARKS - Research of Biomarkers of Response to Proton Beam Therapy in Pediatric and Adult Patients: A Genomic, Epigenetic, and Immunological Analysis

Clinical Trial 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 patients (high grade sarcoma, brain tumors and meningioma). This study include collection of clinical data, of tumor samples (collected during standard of care) and a blood sample for alive patients.

Clinical Trial 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, PBT is also recognised in adults as a valid option providing life expectancy > 10 years, for inoperable axial or head and neck sarcomas, low grade brain tumors (i.e. low grade astrocytoma, oligodendroglioma and ependymoma), non-operated meningioma of skull base and other rare clinical situations (re-irradiation, locally aggressive tumor malignant or not arising in sites which preclude R0 or R1 surgical resection). Recently, Jhaveri et al. have reported the retrospective analysis of a National Cancer Data Base (NCDB) and shown an improved overall survival in adult Grade I-IV glioma patients treated with PBT versus patients treated with radiotherapy (XRT). Positive impact on toxicity free survival and general health status of patients were reported in others indications. centers join their expertise (pediatric, brain and sarcoma cancers for Centre Léon Bérard (CLB) and protons for CAL) and their recruitment to optimize the treatment strategy for these patients. The Centre Leon Bérard recently reported on the ProfilER protocol (NCT01774409). It is the largest molecular characterization program in France with now over 4000 patients included. It enabled to identify genomic biomarkers of radio resistance. In this context, the investigator's proposal is to conduct a genomic, epigenetic, and immunological analysis of patients treated with proton beam therapy with the aim to identify Biomarkers of response to PBT in pediatric and adult patients. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04367779
Study type Observational
Source Centre Leon Berard
Contact Gwenaële Garin
Phone + 33 (0)4 78 78 28 28
Email gwenaelle.garin@lyon.unicancer.fr
Status Recruiting
Phase
Start date September 24, 2020
Completion date June 2024
View Details
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