REMASTer: Recurrent Brain Metastases After SRS Trial

This study is for people with brain metastases (cancer that has spread to the brain) that have come back after stereotactic radiosurgery (SRS), a type of radiation therapy. It is testing different treatment approaches, including radiation therapy (either after surgery or not at all), steroid therapy, and Laser Interstitial Thermal Therapy (a minimally invasive procedure using the NeuroBlate® System to destroy tumors with heat). The study aims to see how well these treatments prevent the cancer from growing (progressive disease) and how well they help patients stop using steroids without needing more care for radiation necrosis (damage to healthy brain tissue from radiation). You may be able to join if you are 18 or older and have brain metastases from cancer outside the brain, confirmed by an MRI scan.

Study design
This is an interventional study that plans to enroll 261 participants. It is a randomized study, meaning participants will be assigned to different treatment groups by chance.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
For the progressive disease group, participants will be followed from the date of randomization until the cancer progresses or they pass away, for up to 24 months. For the radiation necrosis group, participants will be assessed for three months from randomization to see if they can stop steroids without needing more care.

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NCT05124912

REMASTer: REcurrent Brain Metastases After SRS Trial

Recruiting
NAAges 18+InterventionalTreatment
Monteris Medical
~261 participants
Updated 2026-06-18 on ClinicalTrials.gov
What's tested:Radiation TherapySteroid TherapyLaser Interstitial Thermal Therapy

At a glance

Recruiting sites
8 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progressive Disease Cohort
Measured over 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
+1 more outcome measured
Brain Metastases
Radiation Necrosis
Recurrent Tumor
Recurrent Metastases
9 sites across 7 states
North Carolina2
Ohio2
California1
Illinois1
Maryland1
Missouri1
Wisconsin1
  • Peter Fecci, MD · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver

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  • Progressive Disease CohortFrom 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

    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.

  • Radiation Necrosis CohortAssessed for a three month period from time of randomization to steroid freedom without escalation of care.

    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.