Location via proxy:   [ UP ]  
[Report a bug]   [Manage cookies]                
Scribd Logo
Upload

Welcome to Scribd!

  • 111 views

    Protocol Summary

    Uploaded by

    api-602263051
    This document summarizes the NRG-BN003 Phase III clinical trial protocol. The trial is evaluating whether radiation therapy provides benefit compared to observation alone for patients with newly diagnosed and completely resected grade II meningioma. The primary endpoint is progression-free survival. The trial is sponsored by the National Cancer Institute and led by NRG Oncology. Eligible patients must have undergone gross total resection of a grade II meningioma and will be randomized to either observation or radiation therapy using modern techniques such as IMRT.

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd

    Protocol Summary

    Uploaded by

    api-602263051
    111 views28 pages
    This document summarizes the NRG-BN003 Phase III clinical trial protocol. The trial is evaluating whether radiation therapy provides benefit compared to observation alone for patients with newly diagnosed and completely resected grade II meningioma. The primary endpoint is progression-free survival. The trial is sponsored by the National Cancer Institute and led by NRG Oncology. Eligible patients must have undergone gross total resection of a grade II meningioma and will be randomized to either observation or radiation therapy using modern techniques such as IMRT.

    Original Title

    protocol summary

    Copyright

    © © All Rights Reserved

    Available Formats

    PPTX, PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    This document summarizes the NRG-BN003 Phase III clinical trial protocol. The trial is evaluating whether radiation therapy provides benefit compared to observation alone for patients with newly diagnosed and completely resected grade II meningioma. The primary endpoint is progression-free survival. The trial is sponsored by the National Cancer Institute and led by NRG Oncology. Eligible patients must have undergone gross total resection of a grade II meningioma and will be randomized to either observation or radiation therapy using modern techniques such as IMRT.

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    111 views28 pages

    Protocol Summary

    Uploaded by

    api-602263051
    This document summarizes the NRG-BN003 Phase III clinical trial protocol. The trial is evaluating whether radiation therapy provides benefit compared to observation alone for patients with newly diagnosed and completely resected grade II meningioma. The primary endpoint is progression-free survival. The trial is sponsored by the National Cancer Institute and led by NRG Oncology. Eligible patients must have undergone gross total resection of a grade II meningioma and will be randomized to either observation or radiation therapy using modern techniques such as IMRT.

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    You are on page 1of 28

    PROTOCOL SUMMARY

    DOS 741-501_Protocols and Studies in


    Radiation Oncology

    Sunhee Lee

    NRG-BN003 PHASE III TRIAL


    PROTOCOL SUMMARY

    Introduction of the Trial: Phase & Version Date

    NRG-BN003 Phase III Trial:


    Observation Versus Irradiation for a Gross Totally
    Resected Grade II Meningioma

    NCI Protocol Version Date: December 17, 2019

    NRG-BN003 PHASE III TRIAL


    PROTOCOL SUMMARY

    Introduction of the Trial: Cooperative Group

    NRG-BN003
    This trial is part of the National Clinical Trials Network (NCTN)
    program, which is sponsored by the National Cancer Institute
    (NCI). The trial will be led by NRG Oncology with the
    participation of the network of NCTN organizations.

    NRG-BN003 PHASE III TRIAL


    PROTOCOL SUMMARY

    Introduction of the Trial: Purpose

    This randomized phase III trial studies how well radiation


    therapy works compared with observation in treating patients
    with newly diagnosed grade II meningioma that has been
    completely removed by surgery.

    NRG-BN003 PHASE III TRIAL


    PROTOCOL SUMMARY
    Introduction of the Trial:
    Schema

    NRG-BN003 PHASE III TRIAL


    PROTOCOL SUMMARY

    Endpoints: Primary Endpoint

    The primary endpoint is progression-free survival (PFS).


    The principal objective is to determine the extent of clinical benefit of
    the addition of adjuvant radiotherapy (RT) to gross total resection
    (GTR) for patients with newly diagnosed World Health Organization
    (WHO) grade II meningioma.

    NRG-BN003 PHASE III TRIAL


    PROTOCOL SUMMARY
    Endpoints: Secondary Endpoint
    • Overall survival (OS)
    • Disease-specific survival (DSS)
    • Toxicity (grade 3+, exclusive of expected alopecia)
    • Neurocognitive function (NCF)
    • Outcomes and Patient Reported Outcomes (PRO) measurements
    • Adherence to protocol-specific target and normal tissue parameters
    • Concordance measurements of central versus parent-institution pathology
    • Assessment of pHH3 mitotic index and its correlation with PFS and OS
    • Tissue and specimen collection for future translational research.

    NRG-BN003 PHASE III TRIAL


    PROTOCOL SUMMARY

    Patient Selection Guidelines


    Investigators should consider all other relevant factors
    (medical and non-medical), as well as the risks and benefits
    of the study therapy, when deciding if a patient is an
    appropriate candidate for this trial.

    NRG-BN003 PHASE III TRIAL


    PROTOCOL SUMMARY
    Eligibility Criteria:
    • Must have psychological ability and general health that permits completion of the study requirements
    and required follow up
    • Women of childbearing potential randomized to receive radiation therapy must use medically acceptable
    forms of contraception, hormonal or non-hormonal throughout the entire course of radiation therapy
    • Submission of tumor tissue is required.
    • Must have a newly diagnosed unifocal intracranial meningioma, gross totally resected and histologically
    confirmed as WHO grade II based upon pathology findings
    • Gross total resection (GTR) will be interpreted as modified Simpson grade 1-3 without gross residual
    dural-based or extradural tumor
    • GTR must be confirmed on post-operative imaging following the most recent surgery
    • The patient or legally authorized representative must provide study-specific informed consent prior to
    study entry
    • Age older or equal to 18years
    • History/physical examination, including neurologic examination within 60days

    NRG-BN003 PHASE III TRIAL


    PROTOCOL SUMMARY

    Ineligibility Criteria:
    • Optic nerve sheath meningioma, spinal or other extracranial meningioma, multiple
    meningiomas, hemangiopericytoma
    • Definitive evidence of metastatic meningioma
    • Prior invasive malignancy
    • Previous radiation therapy to the scalp, cranium, brain or skull base and radiation-
    induced meningioma
    • Major medical illness or psychiatric impairments. Such as inability to undergo MRI

    NRG-BN003 PHASE III TRIAL


    PROTOCOL SUMMARY

    Pretreatment Evaluations:

    Pre-operative MRI must be available for


    post-operative evaluation and incorporation
    in the treatment planning activities using
    image registration

    NRG-BN003 PHASE III TRIAL


    PROTOCOL SUMMARY
    Pretreatment Evaluations:
    Immobilization must be used for all patients as it is well
    supported by cranial immobilization technologies.

    In particular, immobilization must ensure that the cranium


    does not move after image-based (i.e. IGRT or otherwise)
    registration and possible position adjustment.

    Motion management techniques are not required.


    NRG-BN003 PHASE III TRIAL
    PROTOCOL SUMMARY
    Daily Treatment Localization:
    Position verification shall be done prior to each treatment and
    should use one of

    - Stereotactic localization using a stereotactic frame

    - Stereoscopic x-ray localization using either internal


    patient landmarks or implanted fiducials

    - Cone-beam CT registration

    NRG-BN003 PHASE III TRIAL


    PROTOCOL SUMMARY
    Treatment Plan:

    Imaging for Structure Definition and Image Registration/Fusion Target


    and critical structures shall be defined on post-operative MRI acquired
    within 1 week of the planning CT scan.

    MRI shall be registered to the planning CT. The concurrent use of


    transverse, coronal and sagittal MRI image sections is encouraged to
    improve 3-dimensional identification of small structure extents

    NRG-BN003 PHASE III TRIAL


    PROTOCOL SUMMARY
    Treatment Technology:

    This protocol provides for photon and proton treatment

    Photon should be IMRT or VMAT

    NRG-BN003 PHASE III TRIAL


    PROTOCOL SUMMARY
    Prescription: Target
    Dose prescription for Photon and Proton:
    prescribe to the PTV and CTV respectively

    NRG-BN003 PHASE III TRIAL


    PROTOCOL SUMMARY
    Prescription: Critical Structures
    Photon and Proton doses to the Lenses,
    Eyes, Optic Nerves, OpticChiasm and
    BrainStem must be defined

    The maximum point doses (defined as a


    Volume equal to or less than 0.03cc
    Within the OAR_PRV) permissible are
    Listed in the table right

    NRG-BN003 PHASE III TRIAL


    PROTOCOL SUMMARY
    Contour: Target Volumes and Margins

    All structures must be named for


    digital RT Data submission
    as listed in the table right

    NRG-BN003 PHASE III TRIAL


    PROTOCOL SUMMARY
    Contour: Critical Structures

    All structures must be named for


    digital RT Data submission
    as listed in the table right

    NRG-BN003 PHASE III TRIAL


    PROTOCOL SUMMARY
    Contour:

    NRG-BN003 PHASE III TRIAL


    PROTOCOL SUMMARY
    OARs and Target Priorities
    Treatment Planning Priorities and Instructions
    Critical structure and target priorities:
    1. OpticChiasm
    2. OpticNerves
    3. BrainStem
    4. CTV
    5. PTV (for Photon)
    6. Other OARs

    NRG-BN003 PHASE III TRIAL


    PROTOCOL SUMMARY

    Dose Calculation & Quality Assurance

    Photon: IROC Houston credentialed algorithm must be used

    Proton: IROC Houston approval process as outlined in the NCI


    guidelines for treatment clinical trial patients

    NRG-BN003 PHASE III TRIAL


    PROTOCOL SUMMARY

    Drug Therapy

    Chemotherapy or Hormonal therapy or


    other agent-based therapy are not applicable for
    this protocol

    NRG-BN003 PHASE III TRIAL


    PROTOCOL SUMMARY

    Assessments: During Treatment

    None, beyond standard of care assessments as clinically indicated


    in the opinion of the treating physician

    NRG-BN003 PHASE III TRIAL


    PROTOCOL SUMMARY
    Assessments:
    in Follow up

    NRG-BN003 PHASE III TRIAL


    PROTOCOL SUMMARY

    Outcomes

    High-risk Meningioma: Initial Outcomes From NRG Oncology/RTOG 0539:


    National Library of medicine published in 2019.

    Adjuvant radiotherapy versus observation following gross total resection for


    atypical meningioma: a systematic review and meta-analysis:
    National Library of medicine published in 2021

    NRG-BN003 PHASE III TRIAL


    PROTOCOL SUMMARY
    References

    1. Rogers CL, Won M, Vogelbaum MA, et al. High-risk


    Meningioma: Initial Outcomes From NRG Oncology/RTOG 0539. Int J
    Radiat Oncol Biol Phys. 2020;106(4):790-799.
    doi:10.1016/j.ijrobp.2019.11.028

    2. Chun SW, Kim KM, Kim MS, et al. Adjuvant radiotherapy versus
    observation following gross total resection for atypical meningioma:
    a systematic review and meta-analysis. Radiat Oncol. 2021;16(1):34.
    Published 2021 Feb 17. doi:10.1186/s13014-021-01759-9

    NRG-BN003 PHASE III TRIAL


    PROTOCOL SUMMARY

    Thank You

    NRG-BN003 PHASE III TRIAL

    You might also like