REMASTer: REcurrent Brain Metastases After SRS Trial

Overview

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

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", 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.
          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 on a max total daily steroid dose equivalent to 4mg of Dexamethasone.
          7. ≥18 years of age
          8. KPS ≥70
          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 ≥ 1.5 X 109/L
               2. Platelet count ≥ 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 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 ≥ 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.
          2. Patients with concomitant newly diagnosed intracranial metastases (concurrent with the
             targetable radiographically progressive lesion), as these will require prioritized and
             different treatment approaches.
          3. Prior bevacizumab use within 4 weeks of study initiation
          4. Patients with additional concurrent malignancies requiring active treatment, except
             non-melanoma skin cancer, or in-situ cancer of the cervix
          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
         12. Patients with rapidly progressing extracranial disease