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Protocol Summary
Protocol Summary
overall great rates, although there were several tumor and treatment factors that were associated
with local recurrence adverse radiation effects, meningeal disease, and overall survival.1 Clinical
trial NRG-BN012 compares the addition of radiation either before or after surgery for patients
with brain metastasis. This is a randomized phase III trial that is estimated to have 236
participants. The primary objective of this trial is to determine if local tumor progression is
within the surgical bed, adverse radiation effects are correlated to post-SRS radiation necrosis, or
nodular meningeal disease is improved in patients that were treated with SRS pre- or post-
surgery. Some of the secondary objectives include, but are not limited to the overall survival,
For a patient to be enrolled into this trial, they need to meet the specific eligible and
exclusion criteria that are set. The patient must have radiographically confirmed 1-4 brain
metastasis that are located less than 5mm from the optic chiasm and outside the brainstem. They
must have either an active or known history of invasive non-central nervous system primary
cancer that is within the last three years. A patient will be excluded from eligibility if they have
leptomeningeal disease, have had prior cranial irradiation, or if they are unable to undergo an
MRI. The patient will also be excluded if they have had a history of a germ cell tumor, small cell
carcinoma, or lymphoma.2
Once the patient is enrolled in the trial, they will have a CT scan done for immobilization
and planning and an MRI that is used for target delineation. Some components of the radiation
therapy treatment include photons, an energy of 4 megavoltage or greater, and a gamma knife or
linear accelerator machine that is used for the delivery. Depending on the size of the planned
target volume the dose will range from 12-20 Gray while sparing surrounding organs at risk.2
2
References
1. About us. RTOG Foundation Inc. Accessed July 15, 2023. https://www.rtog.org/About-
Us
https://irochouston.mdanderson.org/rpc/credentialing/NRG-BN012.pdf.