Stereotactic Radiosurgery Compared With Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) Plus Memantine for 5 or More Brain Metastases
NCT ID: NCT03550391
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
206 participants
INTERVENTIONAL
2018-11-22
2027-12-31
Brief Summary
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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.
Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Hippocampal-avoidant (HA-WBRT) plus Memantine
WBRT 30Gy in 10 fractions + memantine
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:
Hippocampal-avoidant (HA-WBRT) Radiotherapy
30Gy in 10 fractions
Stereotactic Radiosurgery (SRS)
SRS 18-20 or 22Gy in single fraction
Stereotactic Radiosurgery (SRS)
18-20 or 22 Gy in single fraction
Interventions
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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:
Hippocampal-avoidant (HA-WBRT) Radiotherapy
30Gy in 10 fractions
Stereotactic Radiosurgery (SRS)
18-20 or 22 Gy in single fraction
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Alliance for Clinical Trials in Oncology
OTHER
NRG Oncology
OTHER
Canadian Cancer Trials Group
NETWORK
Responsible Party
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Principal Investigators
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David Roberge
Role: STUDY_CHAIR
CHUM-Centre Hospitalier de l'Universite de Montreal
Michael Chan
Role: STUDY_CHAIR
Wake Forest School of Medicine, Winston-Salem, NC
Vina Gondi
Role: STUDY_CHAIR
Northwestern Medicine Cancer Center, Warrenville IL
Locations
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University of Arizona Cancer Center-Orange Grove Campus
Tucson, Arizona, United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States
City of Hope Corona
Corona, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
City of Hope at Irvine Lennar
Irvine, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
City of Hope Antelope Valley
Lancaster, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States
Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova, California, United States
Rohnert Park Cancer Center
Rohnert Park, California, United States
The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California, United States
South Sacramento Cancer Center
Sacramento, California, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States
City of Hope South Pasadena
South Pasadena, California, United States
Kaiser Permanente Cancer Treatment Center
South San Francisco, California, United States
City of Hope South Bay
Torrance, California, United States
City of Hope Upland
Upland, California, United States
Boca Raton Regional Hospital
Boca Raton, Florida, United States
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
Memorial Hospital West
Pembroke Pines, Florida, United States
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Piedmont Hospital
Atlanta, Georgia, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States
Northwestern University
Chicago, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
OSF Saint Francis Medical Center
Peoria, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States
Community Cancer Center North
Indianapolis, Indiana, United States
Iowa Methodist Medical Center
Des Moines, Iowa, United States
Luminis Health Anne Arundel Medical Center
Annapolis, Maryland, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, United States
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Siteman Cancer Center-South County
St Louis, Missouri, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
Billings Clinic Cancer Center
Billings, Montana, United States
Benefis Sletten Cancer Institute
Great Falls, Montana, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, United States
AtlantiCare Surgery Center
Egg Harbor, New Jersey, 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
Mission Hospital
Asheville, North Carolina, United States
Cone Health Cancer Center
Greensboro, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Fox Chase Cancer Center Buckingham
Furlong, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States
Self Regional Healthcare
Greenwood, South Carolina, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
Dartmouth Cancer Center - North
Saint Johnsbury, Vermont, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, Canada
QEII Health Sciences Centre/Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada
London Regional Cancer Program
London, Ontario, Canada
University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada
CSSS Champlain-Charles Le Moyne
Greenfield Park, Quebec, Canada
CHUM - Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
The Research Institute of the McGill University Health Centre (MUHC)
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
Québec, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCI-2018-00395
Identifier Type: OTHER
Identifier Source: secondary_id
CCTG CE.7
Identifier Type: -
Identifier Source: org_study_id