Intracavitary Carrier-embedded Cs131 Brachytherapy for Recurrent Brain Metastases: a Randomized Phase II Study
1 other identifier
interventional
103
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2020
Longer than P75 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 24, 2020
CompletedFirst Submitted
Initial submission to the registry
December 28, 2020
CompletedFirst Posted
Study publicly available on registry
December 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
January 13, 2026
January 1, 2026
5.9 years
December 28, 2020
January 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
freedom from local progression
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.
9 months following surgery
Secondary Outcomes (1)
wound complications
3 months
Study Arms (2)
Resection without brachytherapy
ACTIVE COMPARATORPatients will undergo craniotomy.
Resection plus brachytherapy
EXPERIMENTALPatients will undergo craniotomy and patients in the treatment arm will undergo implantation of Cesium 131 brachytherapy in coordination with the radiation oncologist.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Patients will be excluded if intraoperative pathology is not consistent with \>/=5% viable metastatic disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Baptist Health South Florida
Miami, Florida, 33143, United States
Memorial Sloan Kettering at Basking Ridge (Consent Only)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Consent Only)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Commack (Consent Only)
Commack, New York, 11725, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nelson Moss, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Patient will be blinded to their treatment until postoperatively.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 28, 2020
First Posted
December 30, 2020
Study Start
December 24, 2020
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
January 13, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
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.