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.
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 Type
OBSERVATIONAL
Enrollment
100
Centre Léon Bérard
Lyon, France
RECRUITINGCentre Antoine Lacassagne
Nice, France
RECRUITINGIdentify predictive biomarkers for local response at 6 months after the end of Proton Beam Therapy
Correlation between local tumor response according to RECIST 1.1 criteria and expression of biomarkers defined by using different techniques (HTG, WES, RNAseq, IHC)
Time frame: At 6 months after the end of Proton Beam Therapy
To identify predictive biomarkers for clinical outcomes
Correlation between local tumor response according to RECIST 1.1 criteria and expression of biomarkers defined by using different techniques (HTG, WES, RNAseq, IHC)
Time frame: At 12 months and at 24 months after the end of Proton Beam Therapy
To identify predictive biomarkers for clinical outcomes
Correlation between progression free survival and expression of biomarkers expression of biomarkers defined by using different techniques (HTG, WES, RNAseq, IHC)
Time frame: From the start of Proton Beam Therapy until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
To identify predictive biomarkers for clinical outcomes
Correlation between overall survival and expression of biomarkers defined by using different techniques (HTG, WES, RNAseq, IHC)
Time frame: From the start of Proton Beam Therapy until the date of death from any cause, assessed up to 48 months
To identify predictive biomarkers for clinical outcomes
Correlation between radiation related toxicity (only Adverse Event (AE) Grade ≥3) according to NCI-CTCAE V5.0. and expression of biomarkers defined by using different techniques (HTG, WES, RNAseq, IHC)
Time frame: From the start of Proton Beam Therapy until at least 24 months after the end of Proton Beam Therapy
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