May 11 2022
NRG-BN012, an NRG Oncology clinical trial in development will accrue patients with 1-4 resectable brain metastases who are expected to undergo resection of at least one of the metastases. Patients will be stratified based on the number of lesions, primary diagnosis (breast cancer vs. other), location (posterior fossa vs. other), and receipt of targeted or immunotherapy within 4 weeks prior to registration or planned within 8 weeks following surgery, or not. After stratification, patients will be randomly assigned to post-operative resection cavity stereotactic radiosurgery (post-resection SRS), or pre-operative radiosurgery, within the 7 days preceding resection (pre-resection SRS).
Following resection of brain metastases, 59% end up experiencing local failure within or around the resection cavity. Initially, physicians addressed this by treating patients with whole brain radiotherapy following surgery; this was very effective at controlling relapse in the brain, but did not prolong survival, and contributed to neurocognitive impairment.
“Further research indicated that stereotactic radiosurgery (SRS) was able to improve cognitive-deterioration free survival when compared to whole brain radiation, without an impact on overall survival, but the use of post-operative SRS alone led to a decline in local control rates, “stated Stuart H. Burri, MD, of the Levine Cancer Institute and the Principal Investigator of the NRG-BN012 trial. “The use of pre-resection SRS in NRG-BN012 may reduce local failure at the resection cavity as well as the development of nodular meningeal disease propagated by surgical perturbation, which would ultimately improve quality of life and possible cognition and change the standard of care for this population by simply changing the timing of the radiation.”
The primary objective of NRG-BN012 is to compare the time to a composite adverse endpoint of local recurrence, nodular meningeal disease and radiation necrosis between these two treatment approaches to determine whether pre-resection SRS reduces these adverse events. Secondary objectives include assessing symptom burden, overall survival, rates of adverse radiation effect, cognitive factor scoring, symptom severity, activity related interference, neurocognitive function, rates of nodular meningeal disease, rates of local recurrence, rates of distant brain failure, toxicity, and timing to whole brain radiation therapy between the two treatment arms on the trial.
NRG Oncology is aiming to open this trial in 2022. More information on the trial to come.