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Trial record 1 of 1 for:    NCT04690348
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Intracavitary Carrier-embedded Cs131 Brachytherapy for Recurrent Brain Metastases: a Randomized Phase II Study

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ClinicalTrials.gov Identifier: NCT04690348
Recruitment Status : Recruiting
First Posted : December 30, 2020
Last Update Posted : March 31, 2023
Sponsor:
Collaborator:
GT Medical Technologies, Inc.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief Summary:
The purpose of this study is to see if Cs-131 brachytherapy is effective in people with recurrent brain cancer who are scheduled to have brain surgery for removal of their tumor(s). The researchers would like to see whether Cs-131 prevents brain tumors from growing back after surgery.The researchers will compare Cs-131 brachytherapy (which occurs during brain surgery) with the usual approach of brain surgery without brachytherapy. The researchers will compare both the effectiveness and safety of the two approaches.

Condition or disease Intervention/treatment Phase
Recurrent Brain Metastases Procedure: Craniotomy Radiation: Cesium-131 brachytherapy Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective randomized phase II multicenter trial.
Masking: Single (Participant)
Masking Description: Patient will be blinded to their treatment until postoperatively.
Primary Purpose: Treatment
Official Title: Intracavitary Carrier-embedded Cs131 Brachytherapy for Recurrent Brain Metastases: a Randomized Phase II Study
Actual Study Start Date : December 24, 2020
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Resection without brachytherapy
Patients will undergo craniotomy.
 Procedure: Craniotomy
Craniotomy
Experimental: Resection plus brachytherapy
Patients will undergo craniotomy and patients in the treatment arm will undergo implantation of Cesium 131 brachytherapy in coordination with the radiation oncologist.
 Procedure: Craniotomy
Craniotomy

Radiation: Cesium-131 brachytherapy
Intracavitary Cesium-131 brachytherapy


Outcome Measures
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Primary Outcome Measures :
  1. freedom from local progression [ Time Frame: 9 months following surgery ]
    With a contrast enhanced brain MRI scan. Treatment response will be determined based on the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria.


Secondary Outcome Measures :
  1. wound complications [ Time Frame: 3 months ]
    Physical examination including wound examination will be performed, and wound complications (including dehiscence, superficial/deep infection, CSF leak) will be recorded by the evaluating clinicians.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients ≥ 18 years of age who are capable of giving consent
  • Undergoing elective craniotomy for resection of a previously-irradiated brain metastasis with suspicion for viable disease at the time of consent, and anticipated achievement of gross-total or near-total (>/=95%) resection
  • Karnofsky Performance Status score (KPS) of ≥70
  • Ability to undergo brain MRI with gadolinium

Exclusion Criteria:

  • Unable to tolerate MRI or CT imaging
  • Pregnancy (patients must have a negative pregnancy test within 30 days of the operation)
  • Women must agree to not breastfeed for at least 12 weeks after the procedure (lactating and discarding in that interval allowable)
  • Diagnosis of leptomeningeal carcinomatosis or >5 additional active or untreated CNS lesions for a total of >6 active lesions
  • Prior irradiation (EQD2) in excess of 100 Gy to site of implant, using an α/β of 2
  • Apposition of tumor margin to brainstem or optic apparatus
  • Previous infection within the operative field, current active systemic infection requiring systemic therapy, or immunodeficiency
  • Urgent surgery required prior to availability of brachytherapy

Intraoperative Exclusion Criterion:

  • Patients will be excluded if intraoperative pathology is not consistent with >/=5% viable metastatic disease.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04690348


Contacts
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Contact: Nelson Moss, MD 212-639-7075 mossn@mskcc.org
Contact: Brandon Imber, MD 631-212-6346

Locations
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United States, Michigan
Henry Ford Hospital Not yet recruiting
Detroit, Michigan, United States, 48202
Contact: Adam Robin, MD    800-436-7936      
United States, Minnesota
University of Minnesota Not yet recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Clark Chen, MD, PhD    612-624-6666      
United States, New Jersey
Memorial Sloan Kettering at Basking Ridge (Consent Only) Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Nelson Moss, MD    212-639-7075      
Memorial Sloan Kettering Monmouth (Consent Only) Recruiting
Middletown, New Jersey, United States, 07748
Contact: Nelson Moss, MD    212-639-7075      
United States, New York
Memorial Sloan Kettering Commack (Consent Only) Recruiting
Commack, New York, United States, 11725
Contact: Nelson Moss, MD    212-639-7075      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Nelson Moss, MD    212-639-7075      
Contact: Brandon Imber, MD    631-212-6346      
Principal Investigator: Nelson Moss, MD         
Memorial Sloan Kettering Nassau (Limited Protocol Activities) Recruiting
Uniondale, New York, United States, 11553
Contact: Nelson Moss, MD    212-639-7075      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
GT Medical Technologies, Inc.
Investigators
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Principal Investigator: Nelson Moss, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04690348    
Other Study ID Numbers: 20-542
First Posted: December 30, 2020    Key Record Dates
Last Update Posted: March 31, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Memorial Sloan Kettering Cancer Center:
Cs-131 Brachytherapy
Brain Metastasis
20-542
Additional relevant MeSH terms:
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Neoplasm Metastasis
Brain Neoplasms
Recurrence
Disease Attributes
Pathologic Processes
Neoplastic Processes
Neoplasms
 Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases