NRG-BN013:Phase III Trial of Single Fraction Stereotactic Radiosurgery (SRS) Versus Fractionated SRS (FSRS) for Intact Brain Metastases
Objective
Primary Objective: To determine if the time to local failure is improved with FSRS compared to SRS in patients with intact (i.e., unresected) brain metastases.
Secondary Objectives: To compare time to intracranial progression-free survival between FSRS and SRS. To compare overall survival between FSRS and SRS. To determine if the time to local failure is improved with FSRS compared to SRS, as evaluated by central review of imaging. To evaluate if there is any difference in CNS failure patterns (local vs. distant brain failure vs. both) in patients who receive FSRS compared to patients who receive SRS. To compare the rates of radiation necrosis in patients who receive FSRS vs. SRS. To compare the time to salvage WBRT between patients who receive FSRS and those who receive SRS. To compare the rates of post-treatment adverse events associated with FSRS and SRS.
