RecruitingPhase 3NCT03550391

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

Sponsor

Canadian Cancer Trials Group

Enrollment

206 participants

Start Date

Nov 22, 2018

Study Type

INTERVENTIONAL

Conditions

Brain Metastases

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. 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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two types of brain radiation treatment for people who have 5 or more spots of cancer that have spread to the brain. One treatment targets each spot individually (radiosurgery), and the other treats the whole brain at once while protecting the memory centers (hippocampal-avoidant whole brain radiation plus a memory-protecting drug called memantine). **You may be eligible if...** - You have 5 to 15 spots of cancer that have spread to the brain, confirmed by MRI scan within the last 30 days - You have been diagnosed with a solid (non-blood) cancer - The largest brain spot is smaller than 2.5 cm - You are older than 18 years - You are able to complete quality-of-life questionnaires in English or French - Your kidneys are functioning adequately **You may NOT be eligible if...** - You have more than 15 brain metastases - You are unable to complete questionnaires or participate in follow-up assessments - Your kidney function is below the required threshold Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMemantine

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:

RADIATIONHippocampal-avoidant (HA-WBRT) Radiotherapy

30Gy in 10 fractions

PROCEDUREStereotactic Radiosurgery (SRS)

18-20 or 22 Gy in single fraction

Locations(86)

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 Rogel 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

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NCT03550391

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