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Stereotactic Radiosurgery Compared With Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) Plus Memantine for 5 or More Brain Metastases

NCT03550391 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 206

Last updated 2026-05-12

No results posted yet for this study

Summary

Stereotactic radiosurgery (SRS) is a commonly used treatment for brain tumors. It is a one-day (or in some cases two day), out-patient procedure during which a high dose of radiation is delivered to small spots in the brain while excluding the surrounding normal brain.

Whole brain radiation therapy with hippocampal avoidance (HA-WBRT) is when radiation therapy is given to the whole brain, while trying to decrease the amount of radiation that is delivered to the area of the hippocampus. The hippocampus is a brain structure that is important for memory. Memantine is a drug that is given to help relieve symptoms that can be caused by WBRT, including problems with memory and other mental symptoms.

Health Canada, the regulatory body that oversees the use of drugs in Canada, has not approved the sale or use of memantine in combination with WBRT to treat this kind of cancer, although they have allowed its use in this study.

Conditions

Interventions

DRUG

Memantine

20 mg (10 mg divided twice daily). Dose will be escalated by 5 mg per week. Memantine should start at 5 mg, and then increased in 5 mg increments at the following schedule, depending on the patient's response and tolerance:

RADIATION

Hippocampal-avoidant (HA-WBRT) Radiotherapy

30Gy in 10 fractions

PROCEDURE

Stereotactic Radiosurgery (SRS)

18-20 or 22 Gy in single fraction

Sponsors & Collaborators

Principal Investigators

  • David Roberge · CHUM-Centre Hospitalier de l'Universite de Montreal

  • Michael Chan · Wake Forest School of Medicine, Winston-Salem, NC

  • Vina Gondi · Northwestern Medicine Cancer Center, Warrenville IL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-22
Primary Completion
2027-06-30
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States
  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03550391 on ClinicalTrials.gov