CLINICAL TRIAL / NCT05124912
REMASTer: REcurrent Brain Metastases After SRS Trial
- Interventional
- Active
- NCT05124912
Contact Information
- Rena Redic
REMASTer: REcurrent Brain Metastases After SRS 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.
Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers
No
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
- Brain Metastases