Actively Recruiting
REMASTer: REcurrent Brain Metastases After SRS Trial
Led by Monteris Medical · Updated on 2026-02-20
261
Participants Needed
9
Research Sites
333 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
REMASTer: REcurrent Brain Metastases After SRS Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with radiographically proven brain metastases from confirmed non-CNS cancer
- Patients with a measurable, targetable intracranial lesion recurrent after SRS with or without surgery
- Lesion must show at least 25% size increase after prior treatment
- At least 3 months have passed since initial SRS treatment of the target lesion
- Lesion must be suitable for surgical biopsy and LITT as determined by neurosurgeon
- Frozen pathology diagnosis must be possible
- Patient must be symptomatically stable for at least 3 days prior to procedure on a steroid dose equivalent to 4mg dexamethasone or less daily
- Age 18 years or older
- Karnofsky Performance Status of 70 or higher
- Ability and willingness to complete study requirements
- Adequate blood counts: ANC 21.5 x 10^9/L and platelets 100 x 10^9/L within 4 weeks before biopsy
- Serum creatinine less than 1.5 times upper limit of normal within 4 weeks before biopsy
- Negative pregnancy test for females of reproductive potential unless postmenopausal or surgically sterile
- Agreement to use effective contraception during the study if of reproductive potential
- Accessibility for follow-up
You will not qualify if you...
- More than 3 progressing brain lesions at enrollment
- New intracranial metastases concurrent with the target lesion
- Use of bevacizumab within 4 weeks before study start
- Concurrent cancers requiring active treatment except non-melanoma skin cancer or in-situ cervical cancer
- Serious active infection or other medical conditions impairing ability to complete study assessments
- Contraindication or intolerance to steroid therapy
- Ineligibility or inability to tolerate SRS treatment
- Conditions preventing surgical procedures as judged by physicians
- Unwillingness or inability to consent or comply with study requirements
- Diffuse leptomeningeal disease
- Rapidly progressing extracranial disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
UCLA
Los Angeles, California, United States, 90095
Actively Recruiting
2
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
3
University of Maryland
Baltimore, Maryland, United States, 21201
Actively Recruiting
4
WashU
St Louis, Missouri, United States, 63130
Actively Recruiting
5
Duke University Hospital
Durham, North Carolina, United States, 27710
Active, Not Recruiting
6
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
7
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
8
Kettering Health
Kettering, Ohio, United States, 45429
Actively Recruiting
9
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
C
Christa Seligman
CONTACT
K
Kate Weed
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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