CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 206 target
Drug / intervention
Memantine +2 moredrug
Likely dose
Memantine 20 mgfrom record
Key inclusion· 8
  • ✓5 or more brain metastases (maximum 15) on T1 contrast enhanced MRI within 30 days of randomization
  • ✓Pathological diagnosis of non-hematopoietic malignancy
  • ✓Largest brain metastasis <2.5 cm in maximal diameter
  • ✓Age >18 years
Key exclusion· 16
  • ✕Pregnant or nursing women
  • ✕Childbearing potential without adequate contraception
  • ✕Inability to complete brain MRI
  • ✕Known allergy to gadolinium

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03550391
NCT03550391Phase 3RecruitingOn Track
Long Recruiting
CompareCT.gov

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

Canadian Cancer Trials Group·interventional·Posted Jun 8, 2018·Updated Jun 9, 2026

In Brief

A Phase 3 clinical trial evaluating Memantine, Hippocampal-avoidant (HA-WBRT) Radiotherapy, and 1 other intervention for Brain Metastases. Currently recruiting, targeting 206 participants across 86 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBrain Metastases
CountriesCanada, United States
CollaboratorsAlliance for Clinical Trials in Oncology, NRG Oncology

Timeline

Phase 3Recruiting
2019202020212022202320242025202620272028
First PostedJun 8, 2018
Enrollment StartNov 22, 2018
Primary CompletionJun 30, 2027
Study CompletionDec 31, 2027
TodayJul 2, 2026
Enrollment to primary: 8.6 yearsPosted 8.1 years agoPrimary completion in 12 months

Arms & Interventions

Hippocampal-avoidant (HA-WBRT) plus Memantineexperimental

WBRT 30Gy in 10 fractions + memantine

Drug: MemantineRadiation: Hippocampal-avoidant (HA-WBRT) Radiotherapy
Stereotactic Radiosurgery (SRS)experimental

SRS 18-20 or 22Gy in single fraction

Procedure: Stereotactic Radiosurgery (SRS)

Interventions

Memantinedrug

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:

Hippocampal-avoidant (HA-WBRT) Radiotherapyradiation

30Gy in 10 fractions

Stereotactic Radiosurgery (SRS)procedure

18-20 or 22 Gy in single fraction