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REMASTer: REcurrent Brain Metastases After SRS Trial

Primary Purpose

Brain Metastases, Radiation Necrosis, Recurrent Tumor

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Radiation Therapy
Steroid Therapy
Laser Interstitial Thermal Therapy
Sponsored by
Monteris Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Metastases focused on measuring Laser Interstitial Thermal Therapy, Stereotactic Radiosurgry, LITT, SRS, Radiation Necrosis, Brain Metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 of minimum 1.5 cm (1.5 cm being the product of the largest perpendicular diameters as defined by Gd-MRI) that is radiographically recurrent after previous treatment with SRS +/- surgery. 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, with a lesion size of ≥ 1.5cm (1.5cm being the product of the largest perpendicular diameters). To be "targetable" for this study, the lesion should be coverable through a single LITT trajectory and thus have a maximum perpendicular diameter (perpendicular to the laser trajectory) of 3 cm.
  3. Patient must be at least 3 months post initial SRS treatment for 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 on a max steroid dose of 2 mg twice daily for a minimum of 3 days prior to procedure date.
  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 Neuro-Oncology Criteria of Tumor Response for CNS Tumors, with a lesion size of ≥ 1cm (1cm being the product of the largest perpendicular diameters). Of note, there is no exclusion for total number of metastases. However, only one lesion can be selected to be the indexed lesion.
  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 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

Sites / Locations

  • Duke University HospitalRecruiting
  • Wake Forest Baptist Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Recurrent Tumor

Radiation Necrosis

Arm Description

Receives Laser Interstitial Thermal Therapy (LITT) followed by surveillance or Receives Laser Interstitial Thermal Therapy (LITT) followed by hypofractionated radiation therapy (RT).

Receives Laser Interstitial Thermal Therapy (LITT) and best medical management with steroids or Receives best medical management with steroids.

Outcomes

Primary Outcome Measures

Recurrent Tumor Cohort
Determine the effectiveness of LITT using the NeuroBlate® System in combination with repeat SRS on recurrent brain metastases vs LITT alone
Radiation Necrosis Cohort
Determine the effectiveness of LITT using the NeuroBlaste System versus standard medical management via time to steroid cessation, measured in days from LITT procedure, defined as freedom from steroids for a period of four weeks.

Secondary Outcome Measures

Compare treatment approaches with respect to overall survival
Compare treatment approaches, as defined by the assigned study arms after randomization and any subsequent salvage treatment following treatment failure, in respect to overall survival.

Full Information

First Posted
October 26, 2021
Last Updated
March 13, 2023
Sponsor
Monteris Medical
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1. Study Identification

Unique Protocol Identification Number
NCT05124912
Brief Title
REMASTer: REcurrent Brain Metastases After SRS Trial
Official Title
REMASTer: REcurrent Brain Metastases After SRS Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2022 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Monteris Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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 radiographic progression evidence after stereotactic radiosurgery (SRS), with or without resection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastases, Radiation Necrosis, Recurrent Tumor, Recurrent Metastases
Keywords
Laser Interstitial Thermal Therapy, Stereotactic Radiosurgry, LITT, SRS, Radiation Necrosis, Brain Metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
154 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Recurrent Tumor
Arm Type
Other
Arm Description
Receives Laser Interstitial Thermal Therapy (LITT) followed by surveillance or Receives Laser Interstitial Thermal Therapy (LITT) followed by hypofractionated radiation therapy (RT).
Arm Title
Radiation Necrosis
Arm Type
Other
Arm Description
Receives Laser Interstitial Thermal Therapy (LITT) and best medical management with steroids or Receives best medical management with steroids.
Intervention Type
Procedure
Intervention Name(s)
Radiation Therapy
Intervention Description
Post-op hypofractionated therapy or no radiation therapy
Intervention Type
Drug
Intervention Name(s)
Steroid Therapy
Intervention Description
Best medical management with steroid therapy
Intervention Type
Procedure
Intervention Name(s)
Laser Interstitial Thermal Therapy
Intervention Description
Minimally invasive technique to necrotize intracranial lesions using the NeuroBlate® System (NBS)
Primary Outcome Measure Information:
Title
Recurrent Tumor Cohort
Description
Determine the effectiveness of LITT using the NeuroBlate® System in combination with repeat SRS on recurrent brain metastases vs LITT alone
Time Frame
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
Title
Radiation Necrosis Cohort
Description
Determine the effectiveness of LITT using the NeuroBlaste System versus standard medical management via time to steroid cessation, measured in days from LITT procedure, defined as freedom from steroids for a period of four weeks.
Time Frame
Assessed for a three month period from time of randomization to steroid cessation
Secondary Outcome Measure Information:
Title
Compare treatment approaches with respect to overall survival
Description
Compare treatment approaches, as defined by the assigned study arms after randomization and any subsequent salvage treatment following treatment failure, in respect to overall survival.
Time Frame
Compare treatment approaches with respect to overall survival, defined as time from study biopsy to death or study exit, up to 24 months.
Other Pre-specified Outcome Measures:
Title
Describe Quality of Life (QoL) and cognition observed over time
Description
Change from baseline at each follow-up assessment for each cognitive and QoL subscale
Time Frame
From enrollment through 24 months or study exit (whichever comes first). Measurements occur at baseline, post-op visit, 1 month visit, and each subsequent follow up visit until study exit or at 24 months, whichever comes first.
Title
Explore the relationship between radiographic features and biopsy results
Description
Explore radiographic features, measured as change in enhancing lesion volume and T2 FLAIR volume, at each follow up imaging timepoint (post-op and months 1,3,6,9,12,18,24) or until study exit.
Time Frame
From randomization through 24 months or study exit (whichever comes first)
Title
Treatment failure in all cohorts/arms.
Description
Measured in time to salvage therapy
Time Frame
From randomization through 24 months or study exit (whichever comes first)
Title
Overall Survival (OS)
Description
Survival time from randomization
Time Frame
From randomization through 24 months or study exit (whichever comes first)
Title
Freedom from Local Progression (FFLP)
Description
Measure time from procedure to disease progression
Time Frame
From randomization through 24 months or study exit (whichever comes first)
Title
Quality of Life- KPS
Description
Measure change in scoring from baseline over time
Time Frame
From baseline through 24 months or study exit (whichever comes first)
Title
Quality of Life- NCCN Distress
Description
Measure change in scoring from baseline over time
Time Frame
From baseline through 24 months or study exit (whichever comes first)
Title
Quality of Life- FACT-BR
Description
Measure change in scoring from baseline over time
Time Frame
From baseline through 24 months or study exit (whichever comes first)
Title
Cognitive Measure- Trail Making Test
Description
Measure change in scoring from baseline over time
Time Frame
From baseline through 24 months or study exit (whichever comes first)
Title
Cognitive Measure- HVLT
Description
Measure change in scoring from baseline over time
Time Frame
From baseline through 24 months or study exit (whichever comes first)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: Patients with radiographically proven (by gadolinium-enhanced [Gd-] MRI) parenchymal brain metastases from histologically confirmed non-central nervous system (CNS) cancer. Patients with a "targetable", bidimensionally-measurable, intracranial lesion of minimum 1.5 cm (1.5 cm being the product of the largest perpendicular diameters as defined by Gd-MRI) that is radiographically recurrent after previous treatment with SRS +/- surgery. 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, with a lesion size of ≥ 1.5cm (1.5cm being the product of the largest perpendicular diameters). To be "targetable" for this study, the lesion should be coverable through a single LITT trajectory and thus have a maximum perpendicular diameter (perpendicular to the laser trajectory) of 3 cm. Patient must be at least 3 months post initial SRS treatment for the target lesion Target lesion must be amenable to undergo surgical biopsy and LITT treatment as determined by the treating neurosurgeon. Frozen pathology diagnosis must be attainable. Patient must be symptomatically stable on a max steroid dose of 2 mg twice daily for a minimum of 3 days prior to procedure date. ≥18 years of age KPS ≥70 Patient is able and willing to complete study requirements Patients with adequate hematologic parameters (all tests to be performed within <4 weeks of biopsy): ANC ≥ 1.5 X 109/L Platelet count ≥ 100 x 109/L Blood chemistry laboratory value for serum creatinine < 1.5 x ULN (test to be performed within <4 weeks of biopsy) 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) All patients of reproductive potential must agree to use an effective method of contraception during the study 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: 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 Neuro-Oncology Criteria of Tumor Response for CNS Tumors, with a lesion size of ≥ 1cm (1cm being the product of the largest perpendicular diameters). Of note, there is no exclusion for total number of metastases. However, only one lesion can be selected to be the indexed lesion. Patients with concomitant newly diagnosed intracranial metastases (concurrent with the targetable radiographically progressive lesion), as these will require prioritized and different treatment approaches. Prior bevacizumab use within 4 weeks of study initiation Patients with concurrent malignancies requiring active treatment, except non-melanoma skin cancer, or in-situ cancer of the cervix 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 Inability to tolerate or contraindication to steroid therapy (i.e., dexamethasone) Deemed ineligible or unable to tolerate SRS therapy by treating neurosurgeon and/or radiation oncologist Patients with any condition that would prohibit them from undergoing a surgical procedure, at the discretion of the treating physician team Patients unwilling or unable to give consent for participation Patients unable to comply with study requirements
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Menck
Phone
6127990288
Email
lmenck@monteris.com
Facility Information:
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beth Perry
Email
beth.perry@duke.edu
First Name & Middle Initial & Last Name & Degree
Peter Fecci, MD
Facility Name
Wake Forest Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wendy Jenkins
Email
wejenkin@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Adrian Laxton, MD

12. IPD Sharing Statement

Learn more about this trial

REMASTer: REcurrent Brain Metastases After SRS Trial

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