RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2020-12-24
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04690348

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult patients ≥ 18 years of age who are capable of giving consent
  2. * 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
  3. * Karnofsky Performance Status score (KPS) of ≥70
  4. * Ability to undergo brain MRI with gadolinium
  1. * Unable to tolerate MRI or CT imaging
  2. * Pregnancy (patients must have a negative pregnancy test within 30 days of the operation)
  3. * Women must agree to not breastfeed for at least 12 weeks after the procedure (lactating and discarding in that interval allowable)
  4. * Diagnosis of leptomeningeal carcinomatosis or \>5 additional active or untreated CNS lesions for a total of \>6 active lesions
  5. * Prior irradiation (EQD2) in excess of 100 Gy to site of implant, using an α/β of 2
  6. * Apposition of tumor margin to brainstem or optic apparatus
  7. * Previous infection within the operative field, current active systemic infection requiring systemic therapy, or immunodeficiency
  8. * Urgent surgery required prior to availability of brachytherapy
  9. * Patients will be excluded if intraoperative pathology is not consistent with \>/=5% viable metastatic disease.

Contacts and Locations

Study Contact

Nelson Moss, MD
CONTACT
212-639-7075
mossn@mskcc.org
Brandon Imber, MD
CONTACT
631-212-6346

Principal Investigator

Nelson Moss, MD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Baptist Health South Florida
Miami, Florida, 33143
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Memorial Sloan Kettering at Basking Ridge (Consent Only)
Basking Ridge, New Jersey, 07920
United States
Memorial Sloan Kettering Monmouth (Consent Only)
Middletown, New Jersey, 07748
United States
Memorial Sloan Kettering Commack (Consent Only)
Commack, New York, 11725
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-24
Study Completion Date2025-12

Study Record Updates

Study Start Date2020-12-24
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Cs-131 Brachytherapy
  • Brain Metastasis
  • 20-542

Additional Relevant MeSH Terms

  • Recurrent Brain Metastases