NRG-BN012

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

Principal Investigator

Stuart Burri, MD

Status

Disease Site

Brain [BN] Brain Metastases

Phase

III

Developmental Therapeutics

No

Primary Objective

To determine if the time to composite adverse endpoint (CAE) [defined as:1) local tumor progression within the surgical bed; and/or 2) adverse radiation effect (ARE), the imaging correlate of post-SRS radiation necrosis; and/or 3) nodular meningeal disease (nMD)] is improved in patients treated with pre-resection SRS to the intact lesion versus those treated with post-resection SRS.

Patient Population

Patients with known invasive non-CNS primary cancer within the past 3 years (pathologically-diagnosed) with 1-4 areas of brain metastases that have been radiographically-confirmed, one of which requires resection, as defined by MRI with contrast obtained within 14 days prior to registration.

Target Accrual

236