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

Description

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.

Conditions

Recurrent Brain Metastases

Talk to us

Study Overview

On this page

Study Details

Study 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.

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

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

Condition
Recurrent Brain Metastases
Intervention / Treatment

-

Contacts and Locations

Miami

Baptist Health South Florida, Miami, Florida, United States, 33143

Detroit

Henry Ford Hospital, Detroit, Michigan, United States, 48202

Basking Ridge

Memorial Sloan Kettering at Basking Ridge (Consent Only), Basking Ridge, New Jersey, United States, 07920

Middletown

Memorial Sloan Kettering Monmouth (Consent Only), Middletown, New Jersey, United States, 07748

Commack

Memorial Sloan Kettering Commack (Consent Only), Commack, New York, United States, 11725

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

Uniondale

Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale, New York, United States, 11553

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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
  • * Patients will be excluded if intraoperative pathology is not consistent with \>/=5% viable metastatic disease.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Memorial Sloan Kettering Cancer Center,

Nelson Moss, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

2025-12