RecruitingPhase 2NCT04690348

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


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

103 participants

Start Date

Dec 24, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether placing a small radioactive implant (Cs-131 brachytherapy seeds embedded in a collagen carrier) inside the cavity left after brain surgery can reduce the chance that a previously irradiated brain metastasis comes back again. It is a randomized Phase II study. **You may be eligible if...** - You are 18 or older and can give informed consent - You are having planned surgery (craniotomy) to remove a brain metastasis that was previously treated with radiation and is suspected of still being alive (viable) - Your expected extent of removal is at least 95% of the tumor - Your functional status is adequate (Karnofsky ≥ 70) - You can undergo MRI with contrast dye **You may NOT be eligible if...** - You cannot tolerate MRI or CT - You are pregnant (negative test required within 30 days of surgery) - You are breastfeeding and unwilling to pause - Your cancer has spread along the brain lining (leptomeningeal disease) or you have more than 5 additional active brain tumors Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURECraniotomy

Craniotomy

RADIATIONCesium-131 brachytherapy

Intracavitary Cesium-131 brachytherapy


Locations(6)

Baptist Health South Florida

Miami, Florida, United States

Memorial Sloan Kettering at Basking Ridge (Consent Only)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Consent Only)

Middletown, New Jersey, United States

Memorial Sloan Kettering Commack (Consent Only)

Commack, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States

View Full Details on ClinicalTrials.gov

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NCT04690348


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