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

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04690348

Patient View

This Phase II study evaluates the effectiveness and safety of Cs-131 brachytherapy during craniotomy for recurrent brain metastases. Eligible participants are adults undergoing elective craniotomy with a KPS ≥70. Exclusions include pregnancy, certain CNS conditions, and prior excessive irradiation. The trial compares outcomes of surgery with and without Cs-131 brachytherapy.

Patient Parameters

Program Overview

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.

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