Intracavitary Carrier-embedded Cs131 Brachytherapy for Recurrent Brain Metastases: a Randomized Phase II Study

Phase 2

Recruiting

• Conditions: Recurrent Brain Metastases

• Registration Number: NCT04690348
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-24
• Study First Submitted: 2020-12-28
• Study First Submitted QC: 2020-12-28
• Study First Posted: 2020-12-30
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-17
• Last Update Posted: 2025-07-18
• Primary Completion: 2026-12
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 99

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
freedom from local progression	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

Name	Time	Method
wound complications	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.

Trial Locations

Locations (7)

Baptist Health South Florida; 🇺🇸 Miami, Florida, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

Memorial Sloan Kettering at Basking Ridge (Consent Only); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Consent Only); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Commack (Consent Only); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities); 🇺🇸 Uniondale, New York, United States