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

PHASE2RecruitingINTERVENTIONAL
Enrollment

53

Participants

Timeline

Start Date

November 17, 2021

Primary Completion Date

May 31, 2028

Study Completion Date

May 31, 2029

Conditions
Brain Metastases
Interventions
DRUG

Memantine -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)."

RADIATION

WBRT 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.

Trial Locations (2)

53226

RECRUITING

Froedtert Hospital & the Medical College of Wisconsin, Milwaukee

53295

RECRUITING

Clement J. Zablocki Veterans Affairs Medical Center, Milwaukee

All Listed Sponsors
lead

Medical College of Wisconsin

OTHER