RecruitingPhase 2NCT05045950

Optimizing Neurocognition With Whole Brain Radiation Therapy (WBRT) Using Upfront Pulsed Reduced Dose-Rate (PRDR) Technique

Optimizing Neurocognition With Whole Brain Radiation Therapy (WBRT) Using Upfront Pulsed Reduced Dose-Rate (PRDR) Technique (ONCO-RT) - A Phase II Trial of Upfront Pulsed Reduced Dose Rate Whole-Brain Radiation Therapy for Brain Metastases


Sponsor

Medical College of Wisconsin

Enrollment

53 participants

Start Date

Nov 17, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

Study patients will receive Whole-brain radiation therapy (WBRT) - pulsed reduced dose rate (PRDR) within 14 days of registration. All patients will receive single daily fractions using 3D conformal radiotherapy. A dose of 30 Gy in 10 fractions will be delivered using the PRDR technique.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a specialized type of whole-brain radiation therapy (called Pulsed Reduced Dose-Rate, or PRDR) to see if it is gentler on memory and thinking compared to standard whole-brain radiation. It is designed for people whose cancer has spread to the brain. **You may be eligible if...** - You are 18 or older and have cancer that has spread to the brain (brain metastases) - Your cancer was confirmed by biopsy or lab testing - You are in reasonably good physical health (able to carry out light activity) - Your life expectancy from your cancer outside the brain is more than 6 months - You can complete memory and thinking tests in English - Any prior brain treatments (like radiosurgery or surgery) were completed at least 7–14 days ago **You may NOT be eligible if...** - Your cancer started in the blood or the brain/spine itself (e.g., leukemia, brain tumor) - You have cancer spreading along the lining of the brain - You cannot have an MRI with contrast dye - You have had whole-brain radiation before - You have been previously diagnosed with dementia - You are pregnant or not using contraception - English is not your primary language 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

DRUGMemantine -Twice Daily or Extended Release

Both extended release memantine and twice daily memantine dosing will be allowed. Twice daily dosing: The target dose for memantine is 20 mg (10 mg divided twice daily). Dose will be escalated by 5 mg each week to a target of 10 mg twice daily (i.e., 5 mg a day on week 1, then 5 mg twice daily (BID) on week 2, then 10 mg in AM plus 5 mg in PM on week 3, followed by 10 mg in AM plus 10 mg in PM by week 4). Extended Release Memantine: The target dose for extended release memantine is 28 mg. Dose will be escalated by 7 mg per week to a target of 28 mg daily (i.e., 7 mg a day on week 1, then 14 mg a day on week 2, then 21 mg a day on week 3, followed by 28 mg a day by week 4).

RADIATIONWBRT utilizing the PRDR technique

The total dose of 3000 cGy (30 Gy) will be divided 10 fractions of 300 cGy (3 Gy); each fraction will be delivered as a series of 20 cGy (0.2Gy) pulses separated by 3 min time intervals. 20 cGy / 3 min = 6.67 cGy/min (or 0.0667 Gy/min). Total time is determined by the fractionated series and time intervals, meaning 300cGy/20cGy = 15 division x 3 minutes = 45 minutes. Including time to set up, approximate total time per treatment session will be 60 minutes.


Locations(2)

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Clement J. Zablocki Veterans Affairs Medical Center

Milwaukee, Wisconsin, United States

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NCT05045950


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