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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Enrolling; Phase 2

Conditions: Recurrent Brain Metastases

Treatments: Radiation: Cesium-131 brachytherapy; Procedure: Craniotomy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04690348

20-542

Details and patient eligibility

About

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.

Enrollment: 99 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

99 participants in 2 patient groups

Resection without brachytherapy

Active Comparator group

Description:

Patients will undergo craniotomy.

Treatment:

Procedure: Craniotomy

Resection plus brachytherapy

Experimental group

Description:

Patients will undergo craniotomy and patients in the treatment arm will undergo implantation of Cesium 131 brachytherapy in coordination with the radiation oncologist.

Treatment:

Procedure: Craniotomy

Radiation: Cesium-131 brachytherapy