REMASTer: REcurrent Brain Metastases After SRS Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMonteris Medical
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with radiographically proven (by gadolinium-enhanced [Gd-] MRI) parenchymal brain metastases from histologically confirmed non-central nervous system (CNS) cancer.
Patients with a "targetable", bidimensionally-measurable, intracranial lesion that is radiographically recurrent after previous treatment with SRS +/- surgery (craniotomy or LITT). To classify a lesion as radiographically progressive, the lesion must demonstrate a ≥ 25% increase in size following treatment based on the Neuro-Oncology Criteria of Tumor Response for CNS Tumors. To be "targetable" for this study, the lesion should be coverable through a planned single LITT trajectory and thus have a maximum perpendicular diameter (perpendicular to the laser trajectory) of 3 cm. An intra-operative decision to utilize two trajectories is acceptable and patient may remain on study.
Patient must be at least 3 months post initial SRS treatment of the target lesion
Target lesion must be amenable to undergo surgical biopsy and LITT treatment as determined by the treating neurosurgeon.
Disqualifiers
Patients with greater than 3 progressing lesions at time of enrollment. To classify as a radiographically progressive, lesion must demonstrate a ≥ 25% increase in size following treatment based on the RANO criteria. Of note, there is no exclusion for total number of metastases. However, only one lesion can be selected to be the targeted lesion and this lesion alone may be ablated during the study procedure.
Patients with concomitant newly diagnosed intracranial metastases (concurrent with the targetable radiographically progressive lesion), as these will require prioritized and different treatment approaches.
Prior bevacizumab use within 4 weeks of study initiation
Patients with additional concurrent malignancies requiring active treatment, except non-melanoma skin cancer, or in-situ cancer of the cervix
Trial design
Design model
Parallel
Treatments tested in this trial
Radiation Therapy
Procedure/SurgeryPost-op hypofractionated therapy or no radiation therapy
Steroid Therapy
DrugBest medical management with steroid therapy
Laser Interstitial Thermal Therapy
Procedure/SurgeryMinimally invasive technique to necrotize intracranial lesions using the NeuroBlate® System (NBS)
Treatment groups
261 Participants
are divided into 2 treatment groupsGroup A: Recurrent TumorOther 2 interventions
Group B: Radiation NecrosisOther 2 interventions
Trial outcomes
Primary outcomes
1
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 months2
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 outcomes
1
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.2
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 monthsSponsors and contacts
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Source ClinicalTrials.gov