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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
261
Post-op hypofractionated therapy or no radiation therapy
Best medical management with steroid therapy
Minimally invasive technique to necrotize intracranial lesions using the NeuroBlate® System (NBS)
UCLA
Los Angeles, California, United States
RECRUITINGUniversity of Chicago
Chicago, Illinois, United States
RECRUITINGUniversity of Maryland
Baltimore, Maryland, United States
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.
Progressive Disease Cohort: Overall Survival
Compare treatment approaches with respect to 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
Compare treatment approaches with respect to FFLP or neurologic 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
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WashU
St Louis, Missouri, United States
RECRUITINGDuke University Hospital
Durham, North Carolina, United States
RECRUITINGWake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
RECRUITINGCleveland Clinic
Cleveland, Ohio, United States
RECRUITINGKettering Health
Kettering, Ohio, United States
RECRUITINGMedical College of Wisconsin
Milwaukee, Wisconsin, United States
RECRUITING