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
Closed to Accrual
Date Opened To Accrual
August 31 2022
Date Closed to Accrual
October 21 2025
Disease Site
Brain [BN]
Brain Mets
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