REMASTer: REcurrent Brain Metastases After SRS Trial
Summary
Randomized, post-market multi-center study investigating the efficacy of two sets of treatment algorithms in brain metastases (BM) patients at the time of first intervention for radiographic progression after stereotactic radiosurgery (SRS), with or without surgery.
Arms & interventions
- ProcedureRadiation Therapy
Post-op hypofractionated therapy or no radiation therapy
- DrugSteroid Therapy
Best medical management with steroid therapy
- ProcedureLaser Interstitial Thermal Therapy
Minimally invasive technique to necrotize intracranial lesions using the NeuroBlate® System (NBS)
Outcome measures
Primary
Progressive Disease Cohort
Determine the effectiveness of LITT using the NeuroBlate® System with or without repeat SRS on recurrent brain metastases, as measured by freedom from local progression.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Radiation Necrosis Cohort
Determine the effectiveness of LITT using the NeuroBlate System versus standard medical management as measured by time to steroid independence without escalation of care, measured in days from LITT procedure, defined as freedom from steroids for a period of four weeks without escalation of care.
Time frame: Assessed for a three month period from time of randomization to steroid freedom without escalation of care.
Secondary
Progressive Disease Cohort: Overall Survival
Time frame: Compare treatment approaches with respect to overall survival, defined as time from study biopsy to death or study exit, up to 24 months.
Radiation Necrosis Cohort: Freedom from Local Progression (FFLP) or Neurological Death
Time frame: Compare treatment approaches with respect to overall survival, defined as time from study biopsy to death or study exit, up to 24 months
Eligibility criteria
Study locations (9)
UCLA
Los Angeles, California, 90095
University of Chicago
Chicago, Illinois, 60637
University of Maryland
Baltimore, Maryland, 21201
WashU
St Louis, Missouri, 63130
Duke University Hospital
Durham, North Carolina, 27710
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
Cleveland Clinic
Cleveland, Ohio, 44195
Kettering Health
Kettering, Ohio, 45429
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226