Comparing Memantine with Stereotactic Radiosurgery for brain metastases
Official title: Stereotactic Radiosurgery Compared With Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) Plus Memantine for 5 or More Brain Metastases
A Phase III Trial of Stereotactic Radiosurgery Compared With Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) Plus Memantine for 5 or More Brain Metastases
- Phase 3
- 2 groups
- Sites in Calgary, Edmonton and 9 more cities
- Recruiting
Interventions
- Medication
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 therapy
Hippocampal-avoidant (HA-WBRT) Radiotherapy
30Gy in 10 fractions
- Medical procedure
Stereotactic Radiosurgery (SRS)
18-20 or 22 Gy in single fraction
Canadian Sites (13)
9 of 13 recruiting
- Recruiting
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta
- Recruiting
Cross Cancer Institute
Edmonton, Alberta
- Recruiting
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia
- Recruiting
QEII Health Sciences Centre/Nova Scotia Health Authority
Halifax, Nova Scotia
- Recruiting
London Regional Cancer Program
London, Ontario
- Recruiting
University Health Network-Princess Margaret Hospital
Toronto, Ontario
- Recruiting
CHUM - Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec
- Recruiting
Jewish General Hospital
Montreal, Quebec
- Recruiting
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
Québec, Quebec
- Not currently recruiting
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario
- Paused
CSSS Champlain-Charles Le Moyne
Greenfield Park, Quebec
- Paused
The Research Institute of the McGill University Health Centre (MUHC)
Montreal, Quebec
- Paused
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke, Quebec
Eligibility Criteria
See who this study is looking for31 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Patients must have 5 or more brain metastases as counted on a T1 contrast enhanced MRI obtained ≤ 30 days from randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → (maximum 15 brain metastases).
- +Women/men of childbearing potential must have agreed to use a highly effective contraceptive method.
- +The largest brain metastasis must measure \<2.5 cm in maximal diameter.
- +Patients must have a pathological diagnosis (cytological or histological) of a non-hematopoietic malignancy.
- +Patient must be \> 18 years of age.
- +Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French either alone or with assistance.
- +Creatinine clearance must be ≥ 30 ml/min within 28 days prior to registration.
- +The Neurocognitive Testing examiner must have credentialing confirming completion of the neurocognitive testing training.
- +Patient consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more → in the trial to document their willingness to participate.
- +A similar process must be followed for sites outside of Canada as per their respective cooperative group's procedures.
- +Patients must be accessible for treatment and follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →. Investigators must assure themselves the patients randomized on this trial will be available for complete documentation of the treatment, adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more →, and follow-up.
- +In accordance with CCTG policy, protocolProtocolThe detailed plan a study must follow.Read more → treatment is to begin within 14 days of patient enrolment.
- +ECOG performance status 0, 1, or 2.
- +Centre must have the ability to treat patients with either a Gamma Knife, Cyberknife, or a linear accelerator-based radiosurgery system.
- +Facility is credentialed by IROC to perform SRS and HA-WBRT. The treating centre must have completed stereotactic radiosurgery credentialing of the specific system(s) to be used in study patients. The treating centre must have completed IMRT credintialing of this specific IMRT systems to be used in study patients for the purposes of HA-WBRT.
Exclusion
- −Known allergy to gadolinium.
- −Prior allergic reaction to memantine.
- −Widespread definitive leptomeningeal metastasis. This includes cranial nerve palsy, leptomeningeal carcinomatosis, ependymal involvement, cranial nerve involvement on imaging, suspicious linear meningeal enhancement, or cerebrospinal fluid (CSF) positive for tumour cells.
- −A brain metastasis that is located ≤ 5 mm of the optic chiasm or either optic nerve.
- −Surgical resection of a brain metastasis (stereotactic biopsies will be allowed).
- −More than 15 brain metastases on a volumetric T1 contrast MRI (voxels of 1mm or smaller) performed within the past 14 days, or more than 10 metastases in the case of a non-volumetric MRI.
- −Inability to complete a brain MRI.
- −Primary germ cell tumour, small cell carcinoma, or lymphoma.
- −Current alcohol or drug abuse.
- −Current use of NMDA antagonists, such as amantadine, ketamine, or dextromethorphan.
- −Diagnosis of chronic liver disease/cirrhosis of the liver (e.g. Child-Pugh class B or C).
- −Patients with architectural distortion of lateral ventricular systems, which, in the opinion of the local investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, makes hippocampal delineation challenging
- −Pregnant or nursing women.
- −Men or women of childbearing potential who are unwilling to employ adequate contraception.
- −Prior cranial radiation therapy.
- −Planned cytotoxic chemotherapy within 48 hours prior or after the SRS or HA-WBRT.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Memantine, together with one or more of: Hippocampal-avoidant (HA-WBRT) Radiotherapy.
Registry label: A: Hippocampal-avoidant (HA-WBRT) plus Memantine
Group B receives Stereotactic Radiosurgery (SRS).
Registry label: B: Stereotactic Radiosurgery (SRS)
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 206 people.
The study is currently expected to finish around December 2027.
The main measurement is taken over: 4.5 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Overall Survival — measured over 4.5 years.
Neurocognitive progression-free survival — measured over 4.5 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT03550391 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About 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:
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Hippocampal-avoidant (HA-WBRT) RadiotherapyRadiation
30Gy in 10 fractions
From the trial registry — its own words, unedited.
What a radiation is here: A form of radiotherapy or radiation-based treatment being studied.
Read the full explanation → · in clinical review
About Stereotactic Radiosurgery (SRS)Procedure
18-20 or 22 Gy in single fraction
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 4.5 years.
The study as a whole is currently expected to finish around 2027-12-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 206 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 17 locations, including: Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Vancouver, British Columbia, Canada; Halifax, Nova Scotia, Canada; Hamilton, Ontario, Canada; London, Ontario, Canada, and 11 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (7)
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
Billings Clinic Cancer Center
Billings, Montana, United States
Benefis Sletten Cancer Institute
Great Falls, Montana, United States
State University of New York Upstate Medical University
Syracuse, New York, United States
SUNY Upstate Medical Center-Community Campus
Syracuse, New York, United States
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.