Brain Metastases, Radiation Necrosis, Recurrent Tumor, Recurrent Metastases
Conditions
Keywords
Laser Interstitial Thermal Therapy, Stereotactic Radiosurgry, LITT, SRS, Radiation Necrosis, Brain Metastases
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.
Interventions
PROCEDURERadiation Therapy
Post-op hypofractionated therapy or no radiation therapy
DRUGSteroid Therapy
Best medical management with steroid therapy
PROCEDURELaser Interstitial Thermal Therapy
Minimally invasive technique to necrotize intracranial lesions using the NeuroBlate® System (NBS)
Sponsors
Monteris Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progressive Disease Cohort | 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 | Determine the effectiveness of LITT using the NeuroBlate® System with or without repeat SRS on recurrent brain metastases, as measured by freedom from local progression. |
| Radiation Necrosis Cohort | Assessed for a three month period from time of randomization to steroid freedom without escalation of care. | Determine the effectiveness of LITT using the NeuroBlate System versus standard medical management as measured by time to steroid independence without escalation of care, measured in days from LITT procedure, defined as freedom from steroids for a period of four weeks without escalation of care. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progressive Disease Cohort: Overall Survival | Compare treatment approaches with respect to overall survival, defined as time from study biopsy to death or study exit, up to 24 months. | Compare treatment approaches with respect to overall survival. |
| Radiation Necrosis Cohort: Freedom from Local Progression (FFLP) or Neurological Death | Compare treatment approaches with respect to overall survival, defined as time from study biopsy to death or study exit, up to 24 months | Compare treatment approaches with respect to FFLP or neurologic death |
Countries
United States
Contacts
CONTACTChrista Seligman
CONTACTKate Weed
PRINCIPAL_INVESTIGATORPeter Fecci, MD
University of Colorado, Denver
Outcome results
None listed