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Stereotactic Radiosurgery vs. HA-WBRT + Memantine for Brain Cancer

Phase 3
Recruiting
Research Sponsored by Canadian Cancer Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have a pathological diagnosis (cytological or histological) of a non-hematopoietic malignancy
The largest brain metastasis must measure <2.5 cm in maximal diameter
Must not have
Prior cranial radiation therapy
Inability to complete a brain MRI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4.5 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial is testing whether memantine used in combination with HA-WBRT helps to improve mental function (measured by how well patients can remember things) compared to those who receive HA-WBRT alone.

Who is the study for?
This trial is for adults with 5 to 15 brain metastases from non-blood cancers, where the largest tumor is smaller than 2.5 cm. They must be able to undergo specific types of radiosurgery and HA-WBRT at certified centers, complete neurocognitive tests, and use effective contraception if needed. Excluded are pregnant/nursing individuals, those with allergies to gadolinium or memantine, prior cranial radiation therapy recipients, patients with certain brain conditions or liver disease.
What is being tested?
The study compares Stereotactic Radiosurgery (SRS), a precise one-day radiation treatment targeting tumors while sparing normal brain tissue, against Whole Brain Radiotherapy avoiding the hippocampus (HA-WBRT) plus Memantine which aims to protect memory during whole-brain treatment. The effectiveness in controlling cancer spread within the brain and impact on memory will be assessed.
What are the potential side effects?
Potential side effects include local reactions from radiation like hair loss or scalp irritation; cognitive changes such as memory problems; fatigue; headaches; nausea; and potentially more serious complications related to targeted high-dose radiation exposure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is not related to blood and has been confirmed by a lab test.
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My largest brain tumor is smaller than 2.5 cm.
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I can take care of myself and am up and about more than half of my waking hours.
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I am older than 18 years.
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I have between 5 and 15 brain tumors as shown on a recent MRI.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had radiation therapy to my brain before.
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I cannot undergo a brain MRI.
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I am scheduled for chemotherapy around the time of my radiation treatment.
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My cancer has spread to the lining of my brain and spinal cord.
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My brain cancer is near my optic nerve or chiasm.
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I have over 15 brain tumors as shown in my recent MRI.
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I am currently taking NMDA antagonist medication.
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I have been diagnosed with chronic liver disease or cirrhosis.
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I am of childbearing age and do not plan to use birth control.
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I have had surgery to remove a brain tumor that spread from another part of my body.
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My cancer is a type of germ cell tumor, small cell carcinoma, or lymphoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Neurocognitive progression-free survival
Overall Survival
Secondary study objectives
Compare the estimated cost of brain-related therapies in patients who receive SRS compared to patients who receive HA-WBRT + memantine.
Neurocognitive progression-free survival in patients who receive SRS compared to HA-WBRT + memantine
Prospectively validate a predictive nomogram for distant brain failure in patients who receive SRS

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Stereotactic Radiosurgery (SRS)Experimental Treatment1 Intervention
SRS 18-20 or 22Gy in single fraction
Group II: Hippocampal-avoidant (HA-WBRT) plus MemantineExperimental Treatment2 Interventions
WBRT 30Gy in 10 fractions + memantine
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Memantine
2006
Completed Phase 4
~1180
Stereotactic Radiosurgery (SRS)
2012
Completed Phase 2
~280

Find a Location

Who is running the clinical trial?

Canadian Cancer Trials GroupLead Sponsor
132 Previous Clinical Trials
69,661 Total Patients Enrolled
Alliance for Clinical Trials in OncologyOTHER
518 Previous Clinical Trials
222,131 Total Patients Enrolled
NRG OncologyOTHER
239 Previous Clinical Trials
102,959 Total Patients Enrolled
Vina GondiStudy ChairNorthwestern Medicine Cancer Center, Warrenville IL
David RobergeStudy ChairCHUM-Centre Hospitalier de l'Universite de Montreal
1 Previous Clinical Trials
15 Total Patients Enrolled
Michael ChanStudy ChairWake Forest School of Medicine, Winston-Salem, NC
1 Previous Clinical Trials
18 Total Patients Enrolled

Media Library

Hippocampal-avoidant (HA-WBRT) Radiotherapy Clinical Trial Eligibility Overview. Trial Name: NCT03550391 — Phase 3
Brain Tumor Research Study Groups: Hippocampal-avoidant (HA-WBRT) plus Memantine, Stereotactic Radiosurgery (SRS)
Brain Tumor Clinical Trial 2023: Hippocampal-avoidant (HA-WBRT) Radiotherapy Highlights & Side Effects. Trial Name: NCT03550391 — Phase 3
Hippocampal-avoidant (HA-WBRT) Radiotherapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03550391 — Phase 3
~60 spots leftby Jun 2027
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