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Brain cancer trial tests if precision radiation can beat whole brain therapy for memory preservation

NCT ID NCT03550391

Disease control Sponsor: Canadian Cancer Trials Group Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase III trial is for people with 5 to 15 brain metastases from cancers that are not blood cancers. It compares two treatments: stereotactic radiosurgery (SRS), which delivers high-dose radiation to small spots in one or two days, versus whole brain radiation that avoids the memory center (hippocampus) plus a drug called memantine to protect memory. The study aims to see which approach better extends life and preserves thinking skills. About 206 participants will be enrolled.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Memantine (a drug to protect memory) and radiation therapy (SRS or HA-WBRT)
What this could lead to
If this trial succeeds, it could show that targeted radiosurgery alone is as good as or better than whole brain radiation plus a memory-protecting drug for controlling brain metastases while preserving cognitive function.
What could go wrong
This is a phase III trial, but results may not apply to all patients. The treatments have risks like radiation side effects, and memantine may not prevent all memory problems. The trial is still recruiting, so outcomes are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 206 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2018

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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. * 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

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Conditions

The condition(s) this trial relates to.

brain cancer metastatic malignant neoplasm in the brain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Brain metastases

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    58 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Arthur J E Child Comprehensive Cancer Centre

    RECRUITING

    Calgary, Alberta, T2N 5G2, Canada

  • AtlantiCare Surgery Center

    RECRUITING

    Egg Harbor, New Jersey, 08234, United States

  • BCCA-Vancouver Cancer Centre

    RECRUITING

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Benefis Sletten Cancer Institute

    RECRUITING

    Great Falls, Montana, 59405, United States

    Contact Email: •••••@•••••

  • Billings Clinic Cancer Center

    SUSPENDED

    Billings, Montana, 59101, United States

  • Boca Raton Regional Hospital

    ACTIVE_NOT_RECRUITING

    Boca Raton, Florida, 33486, United States

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

    RECRUITING

    Québec, Quebec, G1R 2J6, Canada

  • CHUM - Centre Hospitalier de l'Universite de Montreal

    RECRUITING

    Montreal, Quebec, H2X 3E4, Canada

  • CSSS Champlain-Charles Le Moyne

    SUSPENDED

    Greenfield Park, Quebec, J4V 2H1, Canada

  • Carle Cancer Center

    RECRUITING

    Urbana, Illinois, 61801, United States

    Contact Email: •••••@•••••

  • Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

    SUSPENDED

    Sherbrooke, Quebec, J1H 5N4, Canada

  • City of Hope Antelope Valley

    RECRUITING

    Lancaster, California, 93534, United States

    Contact Email: •••••@•••••

  • City of Hope Comprehensive Cancer Center

    RECRUITING

    Duarte, California, 91010, United States

    Contact Email: •••••@•••••

  • City of Hope Corona

    RECRUITING

    Corona, California, 92882, United States

    Contact Email: •••••@•••••

  • City of Hope South Bay

    RECRUITING

    Torrance, California, 90503, United States

  • City of Hope South Pasadena

    RECRUITING

    South Pasadena, California, 91030, United States

    Contact Email: •••••@•••••

  • City of Hope Upland

    RECRUITING

    Upland, California, 91786, United States

    Contact Email: •••••@•••••

  • City of Hope at Irvine Lennar

    RECRUITING

    Irvine, California, 92618, United States

  • Community Cancer Center North

    ACTIVE_NOT_RECRUITING

    Indianapolis, Indiana, 46256, United States

  • Cone Health Cancer Center

    RECRUITING

    Greensboro, North Carolina, 27403, United States

  • Cross Cancer Institute

    RECRUITING

    Edmonton, Alberta, T6G 1Z2, Canada

  • Dartmouth Cancer Center - North

    ACTIVE_NOT_RECRUITING

    Saint Johnsbury, Vermont, 05819, United States

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    ACTIVE_NOT_RECRUITING

    Lebanon, New Hampshire, 03756, United States

  • Decatur Memorial Hospital

    RECRUITING

    Decatur, Illinois, 62526, United States

  • East Carolina University

    ACTIVE_NOT_RECRUITING

    Greenville, North Carolina, 27834, United States

  • Emory Saint Joseph's Hospital

    SUSPENDED

    Atlanta, Georgia, 30342, United States

  • Emory University Hospital/Winship Cancer Institute

    SUSPENDED

    Atlanta, Georgia, 30322, United States

  • Fox Chase Cancer Center

    ACTIVE_NOT_RECRUITING

    Philadelphia, Pennsylvania, 19111, United States

  • Fox Chase Cancer Center Buckingham

    ACTIVE_NOT_RECRUITING

    Furlong, Pennsylvania, 18925, United States

  • Geisinger Medical Center

    RECRUITING

    Danville, Pennsylvania, 17822, United States

    Contact Email: •••••@•••••

  • Geisinger Wyoming Valley/Henry Cancer Center

    RECRUITING

    Wilkes-Barre, Pennsylvania, 18711, United States

    Contact Email: •••••@•••••

  • HSHS Saint Elizabeth's Hospital

    RECRUITING

    O'Fallon, Illinois, 62269, United States

  • Huntsman Cancer Institute/University of Utah

    ACTIVE_NOT_RECRUITING

    Salt Lake City, Utah, 84112, United States

  • Iowa Methodist Medical Center

    RECRUITING

    Des Moines, Iowa, 50309, United States

  • Jewish General Hospital

    RECRUITING

    Montreal, Quebec, H3T 1E2, Canada

  • Juravinski Cancer Centre at Hamilton Health Sciences

    ACTIVE_NOT_RECRUITING

    Hamilton, Ontario, L8V 5C2, Canada

  • Kaiser Permanente Cancer Treatment Center

    ACTIVE_NOT_RECRUITING

    South San Francisco, California, 94080, United States

  • Kaiser Permanente Medical Center - Santa Clara

    ACTIVE_NOT_RECRUITING

    Santa Clara, California, 95051, United States

  • Kaiser Permanente-Rancho Cordova Cancer Center

    ACTIVE_NOT_RECRUITING

    Rancho Cordova, California, 95670, United States

  • Legacy Good Samaritan Hospital and Medical Center

    RECRUITING

    Portland, Oregon, 97210, United States

    Contact Email: •••••@•••••

  • London Regional Cancer Program

    RECRUITING

    London, Ontario, N6A 4L6, Canada

  • Loyola University Medical Center

    SUSPENDED

    Maywood, Illinois, 60153, United States

  • Luminis Health Anne Arundel Medical Center

    ACTIVE_NOT_RECRUITING

    Annapolis, Maryland, 21401, United States

  • Mayo Clinic in Florida

    ACTIVE_NOT_RECRUITING

    Jacksonville, Florida, 32224-9980, United States

  • Mayo Clinic in Rochester

    ACTIVE_NOT_RECRUITING

    Rochester, Minnesota, 55905, United States

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Memorial Hospital West

    ACTIVE_NOT_RECRUITING

    Pembroke Pines, Florida, 33028, United States

  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital

    ACTIVE_NOT_RECRUITING

    Hollywood, Florida, 33021, United States

  • Methodist Medical Center of Illinois

    RECRUITING

    Peoria, Illinois, 61636, United States

  • Mission Hospital

    ACTIVE_NOT_RECRUITING

    Asheville, North Carolina, 28801, United States

  • Missouri Baptist Medical Center

    RECRUITING

    St Louis, Missouri, 63131, United States

  • Moffitt Cancer Center

    ACTIVE_NOT_RECRUITING

    Tampa, Florida, 33612, United States

  • Northwestern Medicine Cancer Center Warrenville

    ACTIVE_NOT_RECRUITING

    Warrenville, Illinois, 60555, United States

  • Northwestern University

    ACTIVE_NOT_RECRUITING

    Chicago, Illinois, 60611, United States

  • OSF Saint Francis Medical Center

    RECRUITING

    Peoria, Illinois, 61637, United States

  • Piedmont Hospital

    ACTIVE_NOT_RECRUITING

    Atlanta, Georgia, 30309, United States

  • QEII Health Sciences Centre/Nova Scotia Health Authority

    RECRUITING

    Halifax, Nova Scotia, B3H 2Y9, Canada

  • Regions Hospital

    SUSPENDED

    Saint Paul, Minnesota, 55101, United States

  • Rohnert Park Cancer Center

    ACTIVE_NOT_RECRUITING

    Rohnert Park, California, 94928, United States

  • SUNY Upstate Medical Center-Community Campus

    SUSPENDED

    Syracuse, New York, 13215, United States

  • Saint Alphonsus Cancer Care Center-Boise

    SUSPENDED

    Boise, Idaho, 83706, United States

  • Saint Francis Medical Center

    RECRUITING

    Cape Girardeau, Missouri, 63703, United States

  • Sanford Bismarck Medical Center

    RECRUITING

    Bismarck, North Dakota, 58501, United States

    Contact Email: •••••@•••••

  • Self Regional Healthcare

    ACTIVE_NOT_RECRUITING

    Greenwood, South Carolina, 29646, United States

  • Siteman Cancer Center at Saint Peters Hospital

    RECRUITING

    City of Saint Peters, Missouri, 63376, United States

    Contact Email: •••••@•••••

  • Siteman Cancer Center at West County Hospital

    RECRUITING

    Creve Coeur, Missouri, 63141, United States

    Contact Email: •••••@•••••

  • Siteman Cancer Center-South County

    RECRUITING

    St Louis, Missouri, 63129, United States

    Contact Email: •••••@•••••

  • South Sacramento Cancer Center

    ACTIVE_NOT_RECRUITING

    Sacramento, California, 95823, United States

  • State University of New York Upstate Medical University

    RECRUITING

    Syracuse, New York, 13210, United States

  • The Permanente Medical Group-Roseville Radiation Oncology

    ACTIVE_NOT_RECRUITING

    Roseville, California, 95678, United States

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

    SUSPENDED

    Montreal, Quebec, H3H 2R9, Canada

  • Tufts Medical Center

    RECRUITING

    Boston, Massachusetts, 02111, United States

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    ACTIVE_NOT_RECRUITING

    Orange, California, 92868, United States

  • UC San Diego Moores Cancer Center

    SUSPENDED

    La Jolla, California, 92093, United States

  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    RECRUITING

    Coral Gables, Florida, 33146, United States

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    RECRUITING

    Deerfield Beach, Florida, 33442, United States

  • UM Sylvester Comprehensive Cancer Center at Plantation

    RECRUITING

    Plantation, Florida, 33324, United States

  • University Health Network-Princess Margaret Hospital

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

    Contact Email: •••••@•••••

  • University of Arizona Cancer Center-North Campus

    RECRUITING

    Tucson, Arizona, 85719, United States

  • University of Arizona Cancer Center-Orange Grove Campus

    RECRUITING

    Tucson, Arizona, 85704, United States

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

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Michigan Rogel Cancer Center

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

    Contact Email: •••••@•••••

  • University of Oklahoma Health Sciences Center

    ACTIVE_NOT_RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • Wake Forest University Health Sciences

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Walter Reed National Military Medical Center

    RECRUITING

    Bethesda, Maryland, 20889-5600, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

    Contact Email: •••••@•••••

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