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

  • STATUS
    Recruiting
  • End date
    Dec 19, 2023
  • participants needed
    76
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 22 December 2021

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.

Details
Condition Recurrent Brain Metastases
Treatment Craniotomy, Cesium-131 brachytherapy
Clinical Study IdentifierNCT04690348
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on22 December 2021

Eligibility

Yes No Not Sure

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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