REMASTer: REcurrent Brain Metastases After SRS Trial
1 other identifier
interventional
261
1 country
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2022
Longer than P75 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2021
CompletedFirst Posted
Study publicly available on registry
November 18, 2021
CompletedStudy Start
First participant enrolled
May 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2028
February 20, 2026
February 1, 2026
4.6 years
October 26, 2021
February 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
Assessed for a three month period from time of randomization to steroid freedom without escalation of care.
Secondary Outcomes (2)
Progressive Disease Cohort: Overall Survival
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 overall survival, defined as time from study biopsy to death or study exit, up to 24 months
Study Arms (2)
Recurrent Tumor
OTHERReceives Laser Interstitial Thermal Therapy (LITT) followed by surveillance or Receives Laser Interstitial Thermal Therapy (LITT) followed by hypofractionated radiation therapy (RT).
Radiation Necrosis
OTHERReceives Laser Interstitial Thermal Therapy (LITT) and best medical management with steroids or Receives best medical management with steroids.
Interventions
Minimally invasive technique to necrotize intracranial lesions using the NeuroBlate® System (NBS)
Eligibility Criteria
You may qualify if:
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- 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.
- Frozen pathology diagnosis must be attainable.
- Patient must be symptomatically stable for a minimum of 3 days prior to the procedure date on a on a max total daily steroid dose equivalent to 4mg of Dexamethasone.
- ≥18 years of age
- KPS ≥70
- Patient is able and willing to complete study requirements
- Patients with adequate hematologic parameters (all tests to be performed within \<4 weeks of biopsy):
- ANC ≥ 1.5 X 109/L
- Platelet count ≥ 100 x 109/L
- Blood chemistry laboratory value for serum creatinine \< 1.5 x ULN (test to be performed within \<4 weeks of biopsy)
- Female patients must have a negative serum pregnancy test at screening. (Not applicable to patients with bilateral oophorectomy and/or hysterectomy or to those patients who are postmenopausal)
- +2 more criteria
You may not qualify if:
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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
- Patients with a serious active infection or other serious underlying medical conditions that would impair the ability of the patient to complete the protocol related QOL questionnaires and cognition assessments
- Inability to tolerate or contraindication to steroid therapy (i.e., dexamethasone)
- Deemed ineligible or unable to tolerate SRS therapy by treating neurosurgeon and/or radiation oncologist
- Patients with any condition that would prohibit them from undergoing a surgical procedure, at the discretion of the treating physician team
- Patients unwilling or unable to give consent for participation
- Patients unable to comply with study requirements
- Patients with diffuse leptomeningeal disease
- Patients with rapidly progressing extracranial disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Monteris Medicallead
Study Sites (9)
UCLA
Los Angeles, California, 90095, United States
University of Chicago
Chicago, Illinois, 60637, United States
University of Maryland
Baltimore, Maryland, 21201, United States
WashU
St Louis, Missouri, 63130, United States
Duke University Hospital
Durham, North Carolina, 27710, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Kettering Health
Kettering, Ohio, 45429, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Fecci, MD
University of Colorado, Denver
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2021
First Posted
November 18, 2021
Study Start
May 10, 2022
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
October 1, 2028
Last Updated
February 20, 2026
Record last verified: 2026-02