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
Open to Accrual
Date Opened To Accrual
August 31 2022
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