Spots Global Cancer Trial Database for Stereotactic Radiosurgery Compared With Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) Plus Memantine for 5 or More Brain Metastases
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Trial Identification
Brief Title: Stereotactic Radiosurgery Compared With Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) Plus Memantine for 5 or More Brain Metastases
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
Study ID: NCT03550391
Conditions
Study Description
Brief 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.
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).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
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
Anne Arundel Medical Center, Annapolis, 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 West County Hospital, Creve Coeur, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Siteman Cancer Center-South County, Saint Louis, Missouri, United States
Missouri Baptist Medical Center, Saint Louis, Missouri, United States
Siteman Cancer Center at Saint Peters Hospital, Saint Peters, Missouri, United States
Billings Clinic Cancer Center, Billings, Montana, United States
Benefis Healthcare- 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 Township, 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
Norris Cotton Cancer Center-North, Saint Johnsbury, Vermont, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Tom Baker 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), Quebec City, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont, Sherbrooke, Quebec, Canada
Contact Details
Name: David Roberge
Affiliation: CHUM-Centre Hospitalier de l'Universite de Montreal
Role: STUDY_CHAIR
Name: Michael Chan
Affiliation: Wake Forest School of Medicine, Winston-Salem, NC
Role: STUDY_CHAIR
Name: Vina Gondi
Affiliation: Northwestern Medicine Cancer Center, Warrenville IL
Role: STUDY_CHAIR
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