Clinical trial NCT04690348: Intracavitary Carrier-embedded Cs131 Brachytherapy for Recurrent Brain Metastases: a Randomized Phase II Study
Official title: Intracavitary Carrier-embedded Cs131 Brachytherapy for Recurrent Brain Metastases: a Randomized Phase II Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Recurrent Brain Metastases
Keywords: Cs-131 Brachytherapy
Brain Metastasis
20-542
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: GT Medical Technologies, Inc.
First posted: 2020-12-30
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized phase II multicenter trial.
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: freedom from local progression
timeFrame: 9 months following surgery
Secondary outcomes:
measure: wound complications
timeFrame: 3 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Baptist Health South Florida
state: Florida
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering at Basking Ridge (Consent Only)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Consent Only)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack (Consent Only)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Nelson Moss, MD
role: PRINCIPAL_INVESTIGATOR
References: