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Sunhee Lee

Instructor William Taylor

Protocols and Studies in Radiation Oncology

July 15, 2022

Protocol Summary: NRG-BN003: Phase III Trial of

Observation versus Irradiation for a Gross Totally Resected Grade II Meningioma

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. This study discusses that the endpoint is progression-free
survival, overall survival, neurocognitive function, and outcome measurements. The guidelines
of selecting patients are very detailed and encountered many factors in which the investigators
determine eligibility criteria.

This protocol provides for photon and proton treatment technology. Pre-operative MRI
are used for post operative evaluation in incorporation in the treatment planning fusion.
Immobilization must be used to ensure cranium does not move for procedure and treatment.
Position verification must be done prior to each treatment and stereotactic frame should be used
for daily treatment. The organs at risk (OARs) are chiasm, optic nerves, brainstem, and other
OARs. Dose calculation and QA must be used IROC credentialed algorithm for both photon and
proton therapy. Chemotherapy, hormonal therapy, and other agent-based therapy are not
applicable to this protocol.

The assessments during treatment are not specified by this protocol. Assessments in
follow up for Arm1 and Arm2 are dose as timely appointment. Performance status, Neurologic
function and MRI surveillance are done during follow up check. There are some studies and
articles about this trial which I use as references.

References
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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