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

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Dec 28, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for people with recurrent brain cancer who need surgery to remove their tumors. The researchers want to find out if a type of brachytherapy called Cs-131, which involves placing a small radioactive source in the brain during surgery, can help prevent these tumors from coming back. They will compare the results of this treatment with traditional surgery alone to see which approach is more effective and safe for patients.

To participate in this study, patients need to be at least 18 years old and capable of giving consent. They should be scheduled for surgery to remove a previously treated brain tumor and have a good chance of removing most of it. Some key factors that would exclude someone from joining the trial include being unable to undergo certain imaging tests, being pregnant, or having too many active brain lesions. If eligible, participants can expect to undergo surgery with either the new brachytherapy method or the usual approach, and the researchers will monitor their recovery and any changes in their condition closely.

Gender

ALL

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.