Clinical trial NCT05124912: REMASTer: REcurrent Brain Metastases After SRS Trial
Official title: REMASTer: REcurrent Brain Metastases After SRS Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Metastases
Radiation Necrosis
Recurrent Tumor
Recurrent Metastases
Keywords: Laser Interstitial Thermal Therapy
Stereotactic Radiosurgry
LITT
SRS
Radiation Necrosis
Brain Metastases
Lead sponsor: Monteris Medical
Sponsor class: INDUSTRY
First posted: 2021-11-18
Enrollment: 261
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Progressive Disease Cohort
timeFrame: 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
measure: Radiation Necrosis Cohort
timeFrame: Assessed for a three month period from time of randomization to steroid freedom without escalation of care.
Secondary outcomes:
measure: Progressive Disease Cohort: Overall Survival
timeFrame: Compare treatment approaches with respect to overall survival, defined as time from study biopsy to death or study exit, up to 24 months.
measure: Radiation Necrosis Cohort: Freedom from Local Progression (FFLP) or Neurological Death
timeFrame: Compare treatment approaches with respect to overall survival, defined as time from study biopsy to death or study exit, up to 24 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Saint Louis
country: United States
facility: WashU
state: Missouri
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Kettering
country: United States
facility: Kettering Health
state: Ohio
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References: