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

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ClinicalTrials.gov Identifier: NCT04367779
Recruitment Status : Recruiting
First Posted : April 29, 2020
Last Update Posted : July 25, 2022
Sponsor:
Information provided by (Responsible Party):
Centre Leon Berard

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 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.

Condition or disease
Brain Cancer Meningioma Sarcoma

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, 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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: PROTONBIOMARKS - Research of Biomarkers of Response to Proton Beam Therapy in Pediatric and Adult Patients: A Genomic, Epigenetic, and Immunological Analysis
Actual Study Start Date : September 24, 2020
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Group/Cohort
A : High Grade Sarcoma
Pediatric and adult patients with High Grade Sarcoma treated or to be treated with Proton Beam Therapy (PBT) and not candidate to surgery before PBT.
B : Brain tumors
Pediatric and adult patients with Brain Tumors treated or to be treated with Proton Beam Therapy (PBT) and not candidate to surgery before PBT.
C : Meningioma
Pediatric and adult patients with Meningioma treated or to be treated with Proton Beam Therapy (PBT) and not candidate to surgery before PBT.



Primary Outcome Measures :
  1. Identify predictive biomarkers for local response at 6 months after the end of Proton Beam Therapy [ Time Frame: 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)


Secondary Outcome Measures :
  1. To identify predictive biomarkers for clinical outcomes [ Time Frame: At 12 months and at 24 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)

  2. To identify predictive biomarkers for clinical outcomes [ 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 ]
    Correlation between progression free survival and expression of biomarkers expression of biomarkers defined by using different techniques (HTG, WES, RNAseq, IHC)

  3. To identify predictive biomarkers for clinical outcomes [ Time Frame: From the start of Proton Beam Therapy until the date of death from any cause, assessed up to 48 months ]
    Correlation between overall survival and expression of biomarkers defined by using different techniques (HTG, WES, RNAseq, IHC)

  4. To identify predictive biomarkers for clinical outcomes [ Time Frame: From the start of Proton Beam Therapy until at least 24 months after the end of Proton Beam Therapy ]
    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)


Biospecimen Retention:   Samples With DNA
Tumor sample(s) (FFPE and/or Frozen) from primary tumor (biopsy or surgery specimen) Blood sample (only for alive patients) collected at the time of PBT initiation or during any clinical exam performed after validation of inclusion


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Alive or Dead cancer patients with high grade sarcoma, brain tumors or meningioma Previously treated with PBT since 2016 (Retrospective cohort) or Patients to be treated with PBT (Prospective cohort)
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04367779


Contacts
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Contact: Gwenaële Garin + 33 (0)4 78 78 28 28 gwenaelle.garin@lyon.unicancer.fr
Contact: Claude Line + 33 (0)4 78 78 28 28 line.claude@lyon.unicancer.fr

Locations
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France
Centre Léon Bérard Recruiting
Lyon, France, 69008
Contact: Claude Line    +33(0)4 78 78 28 28    line.claude@lyon.unicancer.fr   
Sub-Investigator: SUNYACH Marie-Pierre         
Sub-Investigator: GREGOIRE Vincent         
Sub-Investigator: TANGUY Ronan         
Sub-Investigator: POMMIER Pascal         
Centre Antoine Lacassagne Recruiting
Nice, France, 06189
Contact: BONDIAU Pierre    04 92 03 12 72    pierre-yves.bondiau@nice.unicancer.fr   
Sub-Investigator: DOYEN Jérôme         
Sponsors and Collaborators
Centre Leon Berard
Investigators
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Principal Investigator: Claude Line Centre Leon Berard
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Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT04367779    
Other Study ID Numbers: ET19-284
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: July 25, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Leon Berard:
Proton Beam Therapy
Biomarkers
Pediatric and adult cancers
Proton Therapy
Additional relevant MeSH terms:
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Meningioma
Brain Neoplasms
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Brain Diseases
Central Nervous System Diseases