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Brain MetastasesPhase 3NCT03550391

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

A Phase 3 study testing Memantine, Hippocampal-avoidant (HA-WBRT) Radiotherapy and Stereotactic Radiosurgery (SRS) in people with Brain Metastases, run by Canadian Cancer Trials Group at 86 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain Metastases
What is being tested?
Memantine, Hippocampal-avoidant (HA-WBRT) Radiotherapy and Stereotactic Radiosurgery (SRS)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
206 participants
Where
86 sitesin 2 countries
Study dates
22 Nov 2018to 31 Dec 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have 5 or more brain metastases as counted on a T1 contrast enhanced MRI obtained ≤ 30 days from randomization (maximum 15 brain metastases).
  • 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.
  • Centre must have the ability to treat patients with either a Gamma Knife, Cyberknife, or a linear accelerator-based radiosurgery system.
  • 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.
Show all 15Show fewer
  • ECOG performance status 0, 1, or 2.
  • 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.
  • 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.
  • Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrolment 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-up. Investigators must assure themselves the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
  • In accordance with CCTG policy, protocol treatment is to begin within 14 days of patient enrolment.
  • Women/men of childbearing potential must have agreed to use a highly effective contraceptive method.

Who cannot join

  • Pregnant or nursing women.
  • Men or women of childbearing potential who are unwilling to employ adequate contraception.
  • Inability to complete a brain MRI.
  • Known allergy to gadolinium.
  • Prior cranial radiation therapy.
  • Planned cytotoxic chemotherapy within 48 hours prior or after the SRS or HA-WBRT.
Show all 16Show fewer
  • Primary germ cell tumour, small cell carcinoma, or lymphoma.
  • 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.
  • Prior allergic reaction to memantine.
  • 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 investigator, makes hippocampal delineation challenging

Trial locations and contacts

86 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Chris O'Callaghan contact

613-533-6430

cocallaghan@ctg.queensu.ca

86 sites in 2 countries

United States73 sites, 38 recruiting

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

    Site Public Contact, 800-865-1125, CancerAnswerLine@med.umich.edu

    Michelle M. Kim

    Recruiting

  • Luminis Health Anne Arundel Medical Center

    Annapolis, Maryland, 21401

    Active, not recruiting

  • Mission Hospital

    Asheville, North Carolina, 28801

    Active, not recruiting

  • Piedmont Hospital

    Atlanta, Georgia, 30309

    Active, not recruiting

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

    Suspended

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

    Suspended

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889-5600

    Site Public Contact, 301-319-2100

    Corbin A. Helis

    Recruiting

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

    Suspended

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

    Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • Boca Raton Regional Hospital

    Boca Raton, Florida, 33486

    Active, not recruiting

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

    Suspended

  • Tufts Medical Center

    Boston, Massachusetts, 02111

    Site Public Contact, 617-636-5000, ContactUsCancerCenter@TuftsMedicalCenter.org

    John E. Mignano

    Recruiting

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

    Site Public Contact, 573-334-2230, sfmc@sfmc.net

    Bryan A. Faller

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Active, not recruiting

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Jiayi Huang

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    Coral Gables, Florida, 33146

    Site Public Contact, 305-243-2647

    Benjamin J. Rich

    Recruiting

  • City of Hope Corona

    Corona, California, 92882

    Site Public Contact, 626-256-4673, becomingapatient@coh.org

    Sean Szeja

    Recruiting

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Jiayi Huang

    Recruiting

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

    Site Public Contact, 570-271-5251, HemonCCTrials@geisinger.edu

    Heath B. Mackley

    Recruiting

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    Deerfield Beach, Florida, 33442

    Site Public Contact, 305-243-2647

    Benjamin J. Rich

    Recruiting

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

    Site Public Contact, 515-241-6727

    Seema Harichand-Herdt

    Recruiting

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

    Site Public Contact, 800-826-4673, becomingapatient@coh.org

    Sean Szeja

    Recruiting

  • AtlantiCare Surgery Center

    Egg Harbor, New Jersey, 08234

    Site Public Contact, 609-748-7200

    James C. Wurzer

    Recruiting

  • Fox Chase Cancer Center Buckingham

    Furlong, Pennsylvania, 18925

    Active, not recruiting

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Cone Health Cancer Center

    Greensboro, North Carolina, 27403

    Site Public Contact, 336-832-0836, stacey.phelps@conehealth.com

    Sarah E. Squire

    Recruiting

  • East Carolina University

    Greenville, North Carolina, 27834

    Active, not recruiting

  • Self Regional Healthcare

    Greenwood, South Carolina, 29646

    Active, not recruiting

  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital

    Hollywood, Florida, 33021

    Active, not recruiting

  • Community Cancer Center North

    Indianapolis, Indiana, 46256

    Active, not recruiting

  • City of Hope at Irvine Lennar

    Irvine, California, 92618

    Site Public Contact, 877-467-3411

    Sean Szeja

    Recruiting

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

    Active, not recruiting

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

    Suspended

  • City of Hope Antelope Valley

    Lancaster, California, 93534

    Site Public Contact, 800-826-4673, becomingapatient@coh.org

    Sean Szeja

    Recruiting

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    Lebanon, New Hampshire, 03756

    Active, not recruiting

  • Loyola University Medical Center

    Maywood, Illinois, 60153

    Suspended

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136

    Site Public Contact, 305-243-2647

    Benjamin J. Rich

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Site Public Contact, 414-805-3666

    Michael W. Straza

    Recruiting

  • HSHS Saint Elizabeth's Hospital

    O'Fallon, Illinois, 62269

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

    Active, not recruiting

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868

    Active, not recruiting

  • Memorial Hospital West

    Pembroke Pines, Florida, 33028

    Active, not recruiting

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

    Active, not recruiting

  • UM Sylvester Comprehensive Cancer Center at Plantation

    Plantation, Florida, 33324

    Site Public Contact, 305-243-2647

    Benjamin J. Rich

    Recruiting

  • Legacy Good Samaritan Hospital and Medical Center

    Portland, Oregon, 97210

    Site Public Contact, 800-220-4937, cancer@lhs.org

    Andrew Y. Kee

    Recruiting

  • Kaiser Permanente-Rancho Cordova Cancer Center

    Rancho Cordova, California, 95670

    Active, not recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

    Active, not recruiting

  • Rohnert Park Cancer Center

    Rohnert Park, California, 94928

    Active, not recruiting

  • The Permanente Medical Group-Roseville Radiation Oncology

    Roseville, California, 95678

    Active, not recruiting

  • South Sacramento Cancer Center

    Sacramento, California, 95823

    Active, not recruiting

  • Dartmouth Cancer Center - North

    Saint Johnsbury, Vermont, 05819

    Active, not recruiting

  • Regions Hospital

    Saint Paul, Minnesota, 55101

    Suspended

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

    Active, not recruiting

  • Kaiser Permanente Medical Center - Santa Clara

    Santa Clara, California, 95051

    Active, not recruiting

  • City of Hope South Pasadena

    South Pasadena, California, 91030

    Site Public Contact, 800-826-4673, becomingapatient@coh.org

    Sean Szeja

    Recruiting

  • Kaiser Permanente Cancer Treatment Center

    South San Francisco, California, 94080

    Active, not recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Jiayi Huang

    Recruiting

  • Siteman Cancer Center-South County

    St Louis, Missouri, 63129

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Jiayi Huang

    Recruiting

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

    Site Public Contact, 314-996-5569

    Bryan A. Faller

    Recruiting

  • State University of New York Upstate Medical University

    Syracuse, New York, 13210

    Site Public Contact, 315-464-5476

    Michael D. Mix

    Recruiting

  • SUNY Upstate Medical Center-Community Campus

    Syracuse, New York, 13215

    Suspended

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Active, not recruiting

  • City of Hope South Bay

    Torrance, California, 90503

    Site Public Contact, 877-467-3411

    Sean Szeja

    Recruiting

  • University of Arizona Cancer Center-Orange Grove Campus

    Tucson, Arizona, 85704

    Site Public Contact, 520-694-8900

    Baldassarre Stea

    Recruiting

  • University of Arizona Cancer Center-North Campus

    Tucson, Arizona, 85719

    Site Public Contact, UACC-IIT@uacc.arizona.edu

    Baldassarre Stea

    Recruiting

  • City of Hope Upland

    Upland, California, 91786

    Site Public Contact, 800-826-4673, becomingapatient@coh.org

    Sean Szeja

    Recruiting

  • Carle Cancer Center

    Urbana, Illinois, 61801

    Site Public Contact, 800-446-5532, Research@carle.com

    Daniel H. Barnett

    Recruiting

  • Northwestern Medicine Cancer Center Warrenville

    Warrenville, Illinois, 60555

    Active, not recruiting

  • Geisinger Wyoming Valley/Henry Cancer Center

    Wilkes-Barre, Pennsylvania, 18711

    Site Public Contact, 570-271-5251, HemonCCTrials@geisinger.edu

    Heath B. Mackley

    Recruiting

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

    Site Public Contact, 336-713-6771

    Michael D. Chan

    Recruiting

Other trials in United States

Canada13 sites, 9 recruiting

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2

    Site Public Contact, 888-823-5923, ctsucontact@westat.com

    Muhammad S. Faruqi

    Recruiting

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

    Site Public Contact, 780-432-8500

    Samir I. Patel

    Recruiting

  • CSSS Champlain-Charles Le Moyne

    Greenfield Park, Quebec, J4V 2H1

    Suspended

  • QEII Health Sciences Centre/Nova Scotia Health Authority

    Halifax, Nova Scotia, B3H 2Y9

    Site Public Contact, 902-473-6000

    Michael N. Ha

    Recruiting

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

    Active, not recruiting

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

    Site Public Contact, 519-685-8600

    Melody Qu

    Recruiting

  • CHUM - Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2X 3E4

    Site Public Contact, 514-890-8000 ext. 12725, info.cr.chum@ssss.gouv.qc.ca

    David Roberge

    Recruiting

  • The Research Institute of the McGill University Health Centre (MUHC)

    Montreal, Quebec, H3H 2R9

    Suspended

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

    Site Public Contact, 514-340-8222 ext. 8248

    Thierry M. Muanza

    Recruiting

  • CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)

    Québec, Quebec, G1R 2J6

    Site Public Contact, rechclinique@crchuq.ulaval.ca

    Isabelle Thibault

    Recruiting

  • Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

    Sherbrooke, Quebec, J1H 5N4

    Suspended

  • University Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

    Site Public Contact, 416-946-4501, clinical.trials@uhn.on.ca

    David B. Shultz

    Recruiting

  • BCCA-Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

    Site Public Contact, 888-939-3333

    Alan M. Nichol

    Recruiting

Other trials in Canada

About this study

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

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.

Read the detailed description

The purpose of this research study is to compare the effects (good or bad) of receiving stereotactic radiosurgery (SRS) versus receiving hippocampal-avoidant whole brain radiotherapy (HA-WBRT) plus a drug called memantine, on brain metastases. Receiving SRS could control cancer that has spread to the brain.

This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the stereotactic radiosurgery (SRS) helps to either slow the growth of cancer or stop it from coming back, compared to the usual approach. Doctors will also look to see if this new approach increases the life span of patients with this type of cancer, and if it helps with quality of life and cancer related symptoms.

The usual approach for patients who are not in a study is treatment with whole brain radiation therapy alone (WBRT).

Being tested
Memantine, Hippocampal-avoidant (HA-WBRT) Radiotherapy, Stereotactic Radiosurgery (SRS)
Medical subject headings
Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 or surgery

    18-20 or 22 Gy in single fraction

Study groups in NCT03550391
Study groupRoleWhat they receive
Hippocampal-avoidant (HA-WBRT) plus MemantineExperimentalWBRT 30Gy in 10 fractions + memantine
Receives: Drug: Memantine; Radiation: Hippocampal-avoidant (HA-WBRT) Radiotherapy
Stereotactic Radiosurgery (SRS)ExperimentalSRS 18-20 or 22Gy in single fraction
Receives: Procedure: Stereotactic Radiosurgery (SRS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    To compare the overall survival in patients with five to fifteen brain metastases who receive SRS compared to patients who receive HA-WBRT + memantine

    Measured: 4.5 years

  2. Neurocognitive progression-free survival

    To compare the neurocognitive progression-free survival in patients with five to fifteen brain metastases who receive SRS compared to patients who receive HA-WBRT + memantine

    Measured: 4.5 years

Secondary outcomes (15)

  1. Time to central nervous system (CNS) failure (local, distant, and leptomeningeal) in patients who receive SRS compared to patients who receive HA-WBRT + memantine

    Measured: 4.5 years

  2. Difference in CNS failure patterns (local, distant, or leptomeningeal) in patients who receive SRS compared to patients who receive HA-WBRT + memantine

    Measured: 4.5 years

  3. Number of salvage procedures following SRS in comparison to HA-WBRT + memantine

    Measured: 4.5 years

  4. Neurocognitive progression-free survival in patients who receive SRS compared to HA-WBRT + memantine

    measured from date the patient is randomized to date at which there is a drop of at least 1.5 standard deviations from baseline in two of the six neurocognitive tests (all tests are standardized based on published norms)

    Measured: 4.5 years

  5. Tabulate and descriptively compare the post-treatment adverse events associated with the interventions.

    Measured: 4.5 years

  6. Time delay to (re-)initiation of systemic therapy in patients receiving SRS in comparison to HA-WBRT + memantine

    Measured: 4.5 years

  7. Prospectively validate a predictive nomogram for distant brain failure in patients who receive SRS

    a predictive nomogram as a clinically useful tool to determine the likelihood of distant brain failure (DBF) at different time points after radiosurgery

    Measured: 4.5 years

  8. Compare the estimated cost of brain-related therapies in patients who receive SRS compared to patients who receive HA-WBRT + memantine.

    Comparison based on payer rates (Medicare for US / provincial heath authorities in Canadian jurisdictions with activity-based funding)

    Measured: 4.5 years

  9. Quality of life, as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) with brain cancer module (BN20)

    Measured: 4.5 years

  10. Quality of life assessed by ECOG performance status

    Measured: 4.5 years

  11. Quality of life, as assessed by EQ-5D-5L

    Measured: 4.5 years

  12. Collect plasma to evaluate whether detectable somatic mutations in liquid biopsy can enhance prediction of the overall survival and development of new brain metastases.

    Measured: 4.5 years

  13. Analysis of serum samples for inflammatory biomarker C-reactive protein and brain-derived-neurotrophic factor (BDNF) to elucidate molecular/genomic mechanisms of neurocognitive decline and associated radiographic changes

    Measured: 4.5 years

  14. Collect whole-brain dosimetry in SRS patients to be prospectively correlated with cognitive toxicity, intracranial control and radiation necrosis

    Measured: 4.5 years

  15. Evaluate serial changes in imaging features found in routine MRI images (T2w changes, morphometry) that may predict tumour control and/or neurocognitive outcomes

    Measured: 4.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2018
  2. Study start22 Nov 2018
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is an international multi-centre, open-label, randomized phase III trial comparing stereotactic radiosurgery compared with hippocampal-avoidant whole brain radiotherapy (HA-WBRT) plus memantine for 5-15 brain metastases
Masking
None (open label)
Enrolment
206 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03550391
Sponsor's protocol ID
CCTG CE.7
Other IDs
NCI-2018-00395
Status last verified
Apr 2026
First submitted
30 Apr 2018
Last updated
9 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Memantine, Hippocampal-avoidant (HA-WBRT) Radiotherapy and Stereotactic Radiosurgery (SRS) in people with Brain Metastases, run by Canadian Cancer Trials Group at 86 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chris O'Callaghan (613-533-6430, cocallaghan@ctg.queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: 4.5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03550391.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.

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