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REMASTer: REcurrent Brain Metastases After SRS Trial

RecruitingNAAges 18 Years - anyAllMonteris Medical
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Patients with radiographically proven (by gadolinium-enhanced \[Gd-\] MRI) parenchymal brain metastases from histologically confirmed non-central nervous system (CNS) cancer 2. Patients with a "targetable", bi-dimensionally-measurable, intracranial lesion that is considered the first radiographic recurrence after upfront treatment with SRS +/- surgery (craniotomy or LITT). Prior whole brain radiation therapy (WBRT) is permitted provided the target lesion is at first progression following SRS +/- surgery, which would have occurred after WBRT. To classify a lesion as radiographically progressive, the lesion must demonstrate a โ‰ฅ 25% increase in size, relative to the post-nadir measurement following treatment with initial SRS, based on the Response Assessment in Neuro-Oncology criteria for CNS Tumors. To be "targetable" for this study, the lesion should be expected to be coverable through a planned single LITT trajectory and thus have a maximum perpendicular diameter (perpendicular to the laser trajectory) of 3 cm. An unanticipated intra-operative decision to utilize two trajectories is acceptable and patient may remain on study 3. Patient must be at least 3 months post initial SRS treatment of the target lesion 4. Target lesion must be amenable to undergo surgical biopsy and LITT treatment as determined by the treating neurosurgeon 5. Frozen pathology diagnosis must be attainable 6. Patient must be symptomatically stable for a minimum of 3 days prior to the procedure date on a max total daily steroid dose equivalent to 4 mg of Dexamethasone 7. โ‰ฅ18 years of age 8. KPS โ‰ฅ70 9. Patient is able and willing to complete study requirements 10. Patients with adequate hematologic parameters (all tests to be performed within \<4 weeks of biopsy): 1. ANC โ‰ฅ 1.5 X 109/L 2. Platelet count โ‰ฅ 100 x 109/L 11. Blood chemistry laboratory value for serum creatinine \< 1.5 x ULN (test to be performed within \<4 weeks of biopsy) 12. 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) 13. All patients of reproductive potential must agree to use an effective method of contraception during the study 14. Patients must be accessible for in-person follow-up Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Patients with greater than 3 progressing lesions at time of enrollment. To classify as a radiographically progressive, lesion must demonstrate a โ‰ฅ 25% increase in size, relative to the post-nadir measurement, 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 target lesion and this lesion alone may be ablated during the study procedure 2. Patients with concomitant newly diagnosed intracranial metastases (concurrent with the targetable radiographically progressive lesion), as these will require prioritized and different treatment approaches. There is no limit to the number of pre-existing or stable non-target metastases 3. Prior bevacizumab use within 4 weeks of study initiation 4. Patients with additional concurrent malignancies, outside of the primary cancer, requiring active treatment, except non-melanoma skin cancer, or in-situ cancer of the cervix e.g. patients with multiple types of cancer on active treatment 5. 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 6. Inability to tolerate or contraindication to steroid therapy (i.e., dexamethasone) 7. Deemed ineligible or unable to tolerate SRS therapy by treating neurosurgeon and/or radiation oncologist 8. Patients with any condition that would prohibit them from undergoing a surgical procedure, at the discretion of the treating physician team 9. Patients unwilling or unable to give consent for participation 10. Patients unable to comply with study requirements 11. Patients with diffuse leptomeningeal disease. Small focal areas of pachymeningeal disease that are considered "stable" are acceptable with approval from study Principal Investigator 12. Patients with rapidly progressing extracranial disease, with limited further treatment options
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What it tests

  • Radiation Therapy
  • Steroid Therapy
  • Laser Interstitial Thermal Therapy
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Where

9 sites
UCLA
Los Angeles, United States
University of Chicago
Chicago, United States
University of Maryland
Baltimore, United States
WashU
St Louis, United States
Duke University Hospital
Durham, United States
Wake Forest Baptist Medical Center
Winston-Salem, United States
Cleveland Clinic
Cleveland, United States
Kettering Health
Kettering, United States

โ€ฆand 1 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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