Should SRS be Delivered Before or After Surgery for Patients with Brain Metastases? (NRG-BN012)

May 10 2023

The NRG-BN012 phase III clinical trial is designed to compare pre-operative versus post-operative stereotactic radiosurgery (SRS) for patients with 1 to 4 brain metastases with one requiring resection. The objectives of this study are to determine if delivering SRS prior to surgical resection can improve tumor control, including nodular meningeal disease, and quality of life while reducing toxicity and the burden of future interventions for this patient population.

Over half of patients who receive surgical resection of their brain metastases experience local failure. Post-operative SRS became a widely adapted standard of care for patients with brain metastases due to its ability to improve local control compared to observation and reduce the rate of cognitive deterioration when compared to whole brain radiation therapy. However post-operative SRS exhibits relatively poor local control at the resection cavity at 1 year following treatment as well as elevated rates of leptomeningeal disease.

“NRG-BN012 was developed with the goal to provide an alternative treatment to the current standard of care by changing the timing of when SRS is delivered to the patient. Our study is building upon current data that suggests pre-operative SRS may improve local control at the resection cavity, reduce radiation necrosis and limit the development of nodular meningeal disease for these patients,” stated Stuart H. Burri, MD, of the Levine Cancer Institute and the Principal Investigator of the NRG-BN012 trial.

Eligible participants that are enrolled onto NRG-BN012 will be stratified by the number of lesions they have (1 or 2-4), by breast cancer histology, posterior fossa resection, and targeted or immunotherapy received or planned 4 weeks prior to or 8 weeks after surgery. Following stratification, patients will be randomly assigned to receive either post-resection SRS to the resection cavity after surgery (Arm 1) or pre-resection SRS within 7 days prior to surgical resection (Arm 2).

The primary objective of the NRG-BN012 trial is to determine time to local tumor progression within the surgical bed, adverse radiation effect (ARE), and nodular meningeal disease with pre-operative SRS. This study has several secondary objectives including assessing the trajectory of symptom burden and of neuro-cognitive function in patients, determining if there are improvements in overall survival or time to whole brain radiotherapy, comparing rates of ARE, nodular meningeal disease, local recurrence, and distant brain failure, and assessing toxicity between treatment arms. Lastly, the trial will be exploring if the type of surgical resection may or may not be associated with the rate of nodular meningeal disease.

Learn more about this trial at Protocol documents and materials are located on the CTSU website

NRG-BN012 has a patient-facing study webpage available as well on the NRG website at

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