Using Cs-131 brachytherapy during surgery for recurrent brain cancer

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

This study is testing whether using Cs-131 brachytherapy during surgery can help adults with recurrent brain cancer have better outcomes than standard surgery alone.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 103 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Memorial Sloan Kettering Cancer Center (other)
• Locations: 6 sites (Miami, Florida and 5 other locations)
• Trial ID: NCT04690348 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of Cs-131 brachytherapy in patients with recurrent brain metastases who are undergoing craniotomy for tumor removal. Participants will receive either Cs-131 brachytherapy during their surgery or the standard surgical approach without brachytherapy. The study aims to compare the safety and effectiveness of these two methods in preventing tumor recurrence post-surgery. Adult patients with a Karnofsky Performance Status score of 70 or higher are eligible to participate.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with recurrent brain metastases who are scheduled for elective craniotomy.

Not a fit: Patients with multiple active CNS lesions or those who have received excessive prior radiation to the treatment site may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the recurrence of brain tumors after surgery, improving patient outcomes.

How similar studies have performed: Previous studies have shown promise with brachytherapy approaches in similar contexts, suggesting potential for success in this trial.

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.

Where this trial is running

Miami, Florida and 5 other locations

• Baptist Health South Florida — Miami, Florida, United States (RECRUITING)
• Memorial Sloan Kettering at Basking Ridge (Consent Only) — Basking Ridge, New Jersey, United States (RECRUITING)
• Memorial Sloan Kettering Monmouth (Consent Only) — Middletown, New Jersey, United States (RECRUITING)
• Memorial Sloan Kettering Commack (Consent Only) — Commack, New York, United States (RECRUITING)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (RECRUITING)
• Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Nelson Moss, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Nelson Moss, MD

Conditions: Recurrent Brain Metastases, Cs-131 Brachytherapy, Brain Metastasis, 20-542