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Brief Title: Memantine Hydrochloride and Whole-Brain Radiotherapy With or Without Hippocampal Avoidance in Reducing Neurocognitive Decline in Patients With Brain Metastases
Official Title: A Randomized Phase III Trial of Memantine and Whole-Brain Radiotherapy With or Without Hippocampal Avoidance in Patients With Brain Metastases
Study ID: NCT02360215
Brief Summary: This randomized phase III trial compares memantine hydrochloride and whole-brain radiotherapy with or without hippocampal avoidance in reducing neurocognitive decline in patients with cancer that has spread from the primary site (place where it started) to the brain. Whole brain radiotherapy (WBRT) is the most common treatment for brain metastasis. Unfortunately, the majority of patients with brain metastases experience cognitive (such as learning and memory) deterioration after WBRT. Memantine hydrochloride may enhance cognitive function by binding to and inhibiting channels of receptors located in the central nervous system. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Using radiation techniques, such as intensity modulated radiotherapy to avoid the hippocampal region during WBRT, may reduce the radiation dose to the hippocampus and help limit the radiation-induced cognitive decline. It is not yet known whether giving memantine hydrochloride and WBRT with or without hippocampal avoidance works better in reducing neurocognitive decline in patients with brain metastases.
Detailed Description: PRIMARY OBJECTIVES: I. Determine whether the addition of whole-brain radiotherapy with hippocampal avoidance (HA-WBRT) increases time to neurocognitive failure at months 2, 4, 6, and 12 as measured by neurocognitive decline on a battery of tests: the Hopkins Verbal Learning Test-Revised (HVLT-R) for Total Recall, Delayed Recall, and Delayed Recognition, Controlled Oral Word Association (COWA), and the Trail Making Test (TMT) Parts A and B. SECONDARY OBJECTIVES: I. Determine whether the addition of HA-WBRT preserves neurocognitive function at months 2, 4, 6, and 12 as separately measured by each test, the HVLT-R for Total Recall, Delayed Recall, and Delayed Recognition; COWA; and TMT Parts A and B. II. Evaluate the potential benefit of HA-WBRT in symptom burden, as measured by the M. D. Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT). III. Assessment of quality adjusted survival and cost analysis using the five-level version of the EuroQol five-dimensional (EQ-5D-5L). IV. Compare cumulative incidence of progression and overall survival after WBRT versus HA-WBRT. V. Compare adverse events between the treatment arms according to the Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0 criteria. TERTIARY OBJECTIVES: I. Collect serum, plasma, and imaging studies for future translational research analyses. II. Evaluate magnetic resonance (MR) imaging biomarkers of white matter injury and hippocampal volumetry at baseline and 6 months as potential predictors of neurocognitive decline and differential benefit from HA-WBRT as compared to WBRT. III. Association of symptom burden and anxiety/depression with neurocognitive function. IV. Evaluate the potential correlation between the prognostic scoring systems Radiation Therapy Oncology Group (RTOG) recursive partitioning analysis (RPA) and the diagnosis-specific graded prognostic assessment (DS-GPA) and neurocognitive function at baseline and overtime. After completion of study treatment, patients are followed up at 12 months.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Lewis and Faye Manderson Cancer Center, Tuscaloosa, Alabama, United States
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
Banner University Medical Center - Tucson, Tucson, Arizona, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center, Burbank, California, United States
Mercy San Juan Medical Center, Carmichael, California, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
UC San Diego Moores Cancer Center, La Jolla, California, United States
Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, United States
Los Angeles County-USC Medical Center, Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
Kaiser Permanente Oakland-Broadway, Oakland, California, United States
Stanford Cancer Institute Palo Alto, Palo Alto, California, United States
Kaiser Permanente-Rancho Cordova Cancer Center, Rancho Cordova, California, United States
Rohnert Park Cancer Center, Rohnert Park, California, United States
Sutter Cancer Centers Radiation Oncology Services-Roseville, Roseville, California, United States
The Permanente Medical Group-Roseville Radiation Oncology, Roseville, California, United States
Mercy Cancer Center - Sacramento, Sacramento, California, United States
Sutter Medical Center Sacramento, Sacramento, California, United States
University of California San Diego, San Diego, California, United States
California Pacific Medical Center-Pacific Campus, San Francisco, California, United States
Stanford Cancer Center South Bay, San Jose, California, United States
Kaiser Permanente Medical Center - Santa Clara, Santa Clara, California, United States
Kaiser Permanente Cancer Treatment Center, South San Francisco, California, United States
Sutter Solano Medical Center/Cancer Center, Vallejo, California, United States
Rocky Mountain Cancer Centers-Boulder, Boulder, Colorado, United States
Penrose-Saint Francis Healthcare, Colorado Springs, Colorado, United States
UCHealth Memorial Hospital Central, Colorado Springs, Colorado, United States
Swedish Medical Center, Englewood, Colorado, United States
Saint Vincent's Medical Center, Bridgeport, Connecticut, United States
Helen F Graham Cancer Center, Newark, Delaware, United States
Christiana Care Health System-Christiana Hospital, Newark, Delaware, 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
University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, Florida, United States
UF Cancer Center at Orlando Health, Orlando, Florida, United States
Cleveland Clinic-Weston, Weston, Florida, United States
Grady Health System, Atlanta, Georgia, United States
Emory University Hospital Midtown, Atlanta, Georgia, 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
Memorial Health University Medical Center, Savannah, Georgia, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler, Savannah, Georgia, United States
Saint Alphonsus Cancer Care Center-Boise, Boise, Idaho, United States
Saint Luke's Mountain States Tumor Institute, Boise, Idaho, United States
Saint Luke's Mountain States Tumor Institute - Meridian, Meridian, Idaho, United States
Saint Luke's Mountain States Tumor Institute - Nampa, Nampa, Idaho, United States
Saint Luke's Mountain States Tumor Institute-Twin Falls, Twin Falls, Idaho, United States
SIH Cancer Institute, Carterville, Illinois, United States
Northwestern University, Chicago, Illinois, United States
John H Stroger Jr Hospital of Cook County, Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
Decatur Memorial Hospital, Decatur, Illinois, United States
Crossroads Cancer Center, Effingham, Illinois, United States
Northwestern Medicine Cancer Center Delnor, Geneva, Illinois, United States
Edward Hines Jr VA Hospital, Hines, Illinois, United States
Condell Memorial Hospital, Libertyville, 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
Memorial Medical Center, Springfield, Illinois, United States
Carle Cancer Center, Urbana, Illinois, United States
Northwestern Medicine Cancer Center Warrenville, Warrenville, Illinois, United States
Parkview Hospital Randallia, Fort Wayne, Indiana, United States
Community Cancer Center East, Indianapolis, Indiana, United States
Community Cancer Center South, Indianapolis, Indiana, United States
Community Cancer Center North, Indianapolis, Indiana, United States
Saint Luke's Hospital, Cedar Rapids, Iowa, United States
University of Kansas Cancer Center, Kansas City, Kansas, United States
Lawrence Memorial Hospital, Lawrence, Kansas, United States
University of Kansas Cancer Center-Overland Park, Overland Park, Kansas, United States
Ascension Via Christi Hospitals Wichita, Wichita, Kansas, United States
Wesley Medical Center, Wichita, Kansas, United States
University of Kentucky/Markey Cancer Center, Lexington, Kentucky, United States
Tulane University Health Sciences Center, New Orleans, Louisiana, United States
University of Maryland/Greenebaum Cancer Center, Baltimore, Maryland, United States
MedStar Union Memorial Hospital, Baltimore, Maryland, United States
UM Upper Chesapeake Medical Center, Bel Air, Maryland, United States
Central Maryland Radiation Oncology in Howard County, Columbia, Maryland, United States
UM Baltimore Washington Medical Center/Tate Cancer Center, Glen Burnie, Maryland, United States
UM Saint Joseph Medical Center, Towson, Maryland, United States
Tufts Medical Center, Boston, Massachusetts, United States
Lahey Hospital and Medical Center, Burlington, Massachusetts, United States
Lowell General Hospital, Lowell, Massachusetts, United States
Saint Joseph Mercy Hospital, Ann Arbor, Michigan, United States
McLaren Cancer Institute-Bay City, Bay City, Michigan, United States
Henry Ford Cancer Institute-Downriver, Brownstown, Michigan, United States
Saint Joseph Mercy Chelsea, Chelsea, Michigan, United States
21st Century Oncology MHP - Clarkston, Clarkston, Michigan, United States
McLaren Cancer Institute-Clarkston, Clarkston, Michigan, United States
Henry Ford Macomb Hospital-Clinton Township, Clinton Township, Michigan, United States
Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States
Henry Ford Hospital, Detroit, Michigan, United States
21st Century Oncology MHP - Farmington, Farmington Hills, Michigan, United States
Genesys Hurley Cancer Institute, Flint, Michigan, United States
McLaren Cancer Institute-Flint, Flint, Michigan, United States
Spectrum Health at Butterworth Campus, Grand Rapids, Michigan, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
McLaren Cancer Institute-Lapeer Region, Lapeer, Michigan, United States
Saint Mary Mercy Hospital, Livonia, Michigan, United States
McLaren Cancer Institute-Macomb, Mount Clemens, Michigan, United States
McLaren Cancer Institute-Central Michigan, Mount Pleasant, Michigan, United States
Mercy Health Mercy Campus, Muskegon, Michigan, United States
McLaren Cancer Institute-Owosso, Owosso, Michigan, United States
McLaren Cancer Institute-Northern Michigan, Petoskey, Michigan, United States
Saint Joseph Mercy Oakland, Pontiac, Michigan, United States
McLaren-Port Huron, Port Huron, Michigan, United States
Lakeland Medical Center Saint Joseph, Saint Joseph, Michigan, United States
21st Century Oncology MHP - Troy, Troy, Michigan, United States
Henry Ford West Bloomfield Hospital, West Bloomfield, Michigan, United States
Mayo Clinic Health System in Albert Lea, Albert Lea, Minnesota, United States
Unity Hospital, Fridley, Minnesota, United States
Mayo Clinic Health Systems-Mankato, Mankato, Minnesota, United States
Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States
Mayo Clinic Radiation Therapy-Northfield, Northfield, Minnesota, United States
Mayo Clinic, Rochester, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park, Saint Louis Park, Minnesota, United States
Saint Francis Medical Center, Cape Girardeau, Missouri, United States
Siteman Cancer Center at West County Hospital, Creve Coeur, Missouri, United States
North Kansas City Hospital, Kansas City, 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
Mercy Hospital Saint Louis, Saint Louis, Missouri, United States
Siteman Cancer Center at Saint Peters Hospital, Saint Peters, Missouri, United States
CoxHealth South Hospital, Springfield, Missouri, United States
Billings Clinic Cancer Center, Billings, Montana, United States
Benefis Healthcare- Sletten Cancer Institute, Great Falls, Montana, United States
Community Medical Hospital, Missoula, Montana, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Renown Regional Medical Center, Reno, Nevada, United States
Wentworth-Douglass Hospital, Dover, New Hampshire, United States
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States
Montefiore Medical Center - Moses Campus, Bronx, New York, United States
New York-Presbyterian/Brooklyn Methodist Hospital, Brooklyn, New York, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York, New York, United States
University of Rochester, Rochester, New York, United States
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
NHRMC Radiation Oncology - 16th Street, Wilmington, North Carolina, United States
Sanford Bismarck Medical Center, Bismarck, North Dakota, United States
Sanford Roger Maris Cancer Center, Fargo, North Dakota, United States
Summa Akron City Hospital/Cooper Cancer Center, Akron, Ohio, United States
Cleveland Clinic Akron General, Akron, Ohio, United States
Case Western Reserve University, Cleveland, Ohio, United States
Cleveland Clinic Cancer Center/Fairview Hospital, Cleveland, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Cleveland Clinic Cancer Center Independence, Independence, Ohio, United States
UH Seidman Cancer Center at Southwest General Hospital, Middleburg Heights, Ohio, United States
University Hospitals Parma Medical Center, Parma, Ohio, United States
Cleveland Clinic Cancer Center Strongsville, Strongsville, Ohio, United States
UHHS-Westlake Medical Center, Westlake, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Legacy Mount Hood Medical Center, Gresham, Oregon, United States
Legacy Good Samaritan Hospital and Medical Center, Portland, Oregon, United States
Abington Memorial Hospital, Abington, Pennsylvania, United States
Crozer-Keystone Regional Cancer Center at Broomall, Broomall, Pennsylvania, United States
Bryn Mawr Hospital, Bryn Mawr, Pennsylvania, United States
Christiana Care Health System-Concord Health Center, Chadds Ford, Pennsylvania, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
Northeast Radiation Oncology Center, Dunmore, Pennsylvania, United States
Crozer Regional Cancer Center at Brinton Lake, Glen Mills, Pennsylvania, United States
Riddle Memorial Hospital, Media, Pennsylvania, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Aria Health-Torresdale Campus, Philadelphia, Pennsylvania, United States
Temple University Hospital, Philadelphia, Pennsylvania, United States
Reading Hospital, West Reading, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre, Pennsylvania, United States
Lankenau Medical Center, Wynnewood, Pennsylvania, United States
Greenville Health System Cancer Institute-Faris, Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Eastside, Greenville, South Carolina, United States
Self Regional Healthcare, Greenwood, South Carolina, United States
The Radiation Oncology Center-Hilton Head/Bluffton, Hilton Head Island, South Carolina, United States
Greenville Health System Cancer Institute-Spartanburg, Spartanburg, South Carolina, United States
Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota, United States
Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States
University of Texas Medical Branch, Galveston, Texas, United States
M D Anderson Cancer Center, Houston, Texas, United States
UTMB Cancer Center at Victory Lakes, League City, Texas, United States
Ogden Regional Medical Center, Ogden, Utah, United States
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
Norris Cotton Cancer Center-North, Saint Johnsbury, Vermont, United States
Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States
Virginia Mason Medical Center, Seattle, Washington, United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital, Yakima, Washington, United States
West Virginia University Healthcare, Morgantown, West Virginia, United States
Wheeling Hospital/Schiffler Cancer Center, Wheeling, West Virginia, United States
Langlade Hospital and Cancer Center, Antigo, Wisconsin, United States
Mayo Clinic Health System-Eau Claire Clinic, Eau Claire, Wisconsin, United States
Aurora Cancer Care-Grafton, Grafton, Wisconsin, United States
Aurora BayCare Medical Center, Green Bay, Wisconsin, United States
UW Cancer Center Johnson Creek, Johnson Creek, Wisconsin, United States
Aurora Cancer Care-Kenosha South, Kenosha, Wisconsin, United States
Gundersen Lutheran Medical Center, La Crosse, Wisconsin, United States
Mayo Clinic Health System-Franciscan Healthcare, La Crosse, Wisconsin, United States
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States
Community Memorial Hospital, Menomonee Falls, Wisconsin, United States
Ascension Columbia Saint Mary's Water Tower Medical Commons, Milwaukee, Wisconsin, United States
Aurora Saint Luke's Medical Center, Milwaukee, Wisconsin, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Aurora Sinai Medical Center, Milwaukee, Wisconsin, United States
Zablocki Veterans Administration Medical Center, Milwaukee, Wisconsin, United States
Vince Lombardi Cancer Clinic - Oshkosh, Oshkosh, Wisconsin, United States
Marshfield Clinic Stevens Point Center, Stevens Point, Wisconsin, United States
Aurora Medical Center in Summit, Summit, Wisconsin, United States
Vince Lombardi Cancer Clinic-Two Rivers, Two Rivers, Wisconsin, United States
Aspirus Regional Cancer Center, Wausau, Wisconsin, United States
Aurora West Allis Medical Center, West Allis, Wisconsin, United States
Diagnostic and Treatment Center, Weston, Wisconsin, United States
Aspirus UW Cancer Center, Wisconsin Rapids, Wisconsin, United States
CHUM - Hopital Notre-Dame, Montreal, Quebec, Canada
McGill University Department of Oncology, Montreal, 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
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ), Quebec City, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont, Sherbrooke, Quebec, Canada
Allan Blair Cancer Centre, Regina, Saskatchewan, Canada
Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada
Name: Paul Brown
Affiliation: NRG Oncology
Role: PRINCIPAL_INVESTIGATOR