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Cs131 Brachytherapy for the Treatment of Recurrent Brain Metastases
Trial Status: active
This phase II trial studies the effect of cesium (Cs)-131 brachytherapy in treating patients with cancer that has spread to the brain from other places in the body (brain metastases) and that has come back (recurrent). Cs-131 brachytherapy involves placing small radioactive seeds (Cs-131 seeds) near the area(s) of the brain where the cancer is being removed. These seeds are permanent, and they temporarily give off radiation to kill any cancer cells that may grow after surgery. Cs-131 brachytherapy may help prevent brain tumors from growing back after surgery.
Inclusion Criteria
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 (equivalent dose [EQD2]) in excess of 100 Gy to site of implant, using an alpha/beta 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: Patients will be excluded if intraoperative pathology is not consistent with >= 5% viable metastatic disease
Additional locations may be listed on ClinicalTrials.gov for NCT04690348.
I. To evaluate whether intracavitary Cs131 brachytherapy increases the rate of local central nervous system (CNS) control at 9 months compared to conventional care among patients undergoing elective craniotomy for previously-irradiated brain metastases.
SECONDARY OBJECTIVES:
I. To determine the difference in rates of radiographic and symptomatic radiation necrosis (RN) at 1 year in index lesions treated with brachytherapy compared to those in the non-brachytherapy arm.
II. To characterize the rates of wound complications at 3 months in patients treated with intracavitary Cs131 and patients who are not treated with brachytherapy.
III. To determine the difference in time to local retreatment at the index site in lesions treated with brachytherapy compared to lesions treated with conventional care.
EXPLORATORY OBJECTIVES:
I. To assess neurocognitive functions prior to surgery and at 3 and 12 months postoperatively.
II. To explore correlations between response and tumor type and somatic genomic alterations
III. To interrogate the immune microenvironment of previously-irradiated brain metastases.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo Cs131 brachytherapy implantation during craniotomy. Additionally, patients undergo magnetic resonance imaging (MRI) of brain throughout the study and may also undergo computed tomography (CT) postoperatively.
ARM II: Patients undergo craniotomy. Additionally, patients undergo MRI of brain throughout the study and may also undergo CT postoperatively.
After completion of study treatment, patients are followed up at 2 weeks, every 3 months for 1 year then every 6 months for 1 year.
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationMemorial Sloan Kettering Cancer Center
