Intracavitary Carrier-embedded Cs131 Brachytherapy for Recurrent Brain Metastases: a Randomized Phase II Study
Running, not enrolling · Phase 2
Conditions studied: Recurrent Brain Metastases
In brief
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.
Key facts
- Study ID
- NCT04690348
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 103
- Starts
- 2020-12-24
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-06-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
- Intraoperative Exclusion Criterion:
- Patients will be excluded if intraoperative pathology is not consistent with >/=5% viable metastatic disease.
Where it is running
- Baptist Health South Florida — Miami, Florida, 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
Full record on ClinicalTrials.gov
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