Comparing the Addition of Radiation before or After Surgery for Patients with Brain Metastases (NRG-BN012)

September 15 2022

NRG-BN012: A Randomized Phase III Trial of Pre-Operative Compared to Post-Operative Stereotactic Radiosurgery in Patients with Resectable Brain Metastases

Local failure in the resection cavity occurs in approximately 60% of patients who receive surgical resection of their brain metastases. The current standard of care for patients with brain metastases where the lesion is 2cm or greater and surgery is indicated is to resect the lesion and treat the resection cavity with stereotactic radiosurgery (SRS). However, not all patients with larger lesions need to undergo surgery and some can be managed or treated with SRS alone.

“Although SRS has been widely adopted as a standard for treating the resection cavity, it still raises concerns regarding local control of the cavity and overall toxicity burden to the patient,” stated Stuart H. Burri, MD, at the Atrium Health Levine Cancer Institute Radiation Therapy Center and the Principal Investigator of the NRG-BN012 trial.

“The NRG-BN012 trial was created to address whether changing the timing of the treatment can improve tumor control, quality of life , reduce risk of nodular meningeal disease and toxicity as well as burden of future interventions. If pre-operative SRS improves these outcomes, the results could be practice-changing,” Dr. Burri added.

Eligible patients on NRG-BN012 will be stratified by number of lesions, breast cancer histology, posterior fossa resection, and targeted or immunotherapy prior to registration or planned following surgery. Following stratification, patients will be randomly assigned to receive either surgery followed by post-resection SRS to the resection cavity 10-30 days after surgery, or to receive pre-resection SRS followed by surgery within 7 days following SRS. The primary objective of this trial is to determine if patients who receive SRS prior to their surgery exhibit improvement in time to composite adverse endpoint via local tumor progression within the surgical bed, adverse radiation effect (ARE), and/or nodular meningeal disease.

This trial will also try to assess the trajectory of symptom burden, overall survival, rates of ARE, time to whole brain radiotherapy, trajectory of neuro-cognitive function, rates of nodular meningeal disease, rates of local recurrence, rates of distant brain failure, and toxicity between the treatment arms. The study will also explore if the type of surgical resection may 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

Stay current with science. Sign up for our newsletter.

Support NRG Oncology.
Help Our Cause.

We are a leading protocol organizations within the National Clinical Trials Network and we seek to improve the lives of cancer patients by conducting practice-changing, multi-institutional clinical and translational research. Learn More

Donate Today

NRG Oncology Foundation, Inc, is a nonprofit, tax-exempt foundation. Donations to NRG Oncology help us conduct this important mission, and are tax-deductible to the extent permitted by law.