Memantine Hydrochloride and Whole-Brain Radiotherapy With or Without Hippocampal Avoidance in Reducing Neurocognitive Decline in Patients With Brain Metastases

PHASE3CompletedINTERVENTIONAL
Enrollment

518

Participants

Timeline

Start Date

July 31, 2015

Primary Completion Date

April 30, 2018

Study Completion Date

August 26, 2019

Conditions
Cognitive ImpairmentMetastatic Malignant Neoplasm in the BrainSolid Neoplasm
Interventions
RADIATION

Whole brain radiation therapy with hippocampal avoidance

Intensity modulated radiation therapy (IMRT) 30 Gy in 10 fractions once per day, 5 days per week for approximately two week; starting within 21 calendar days after randomization.

DRUG

Memantine

Given PO daily during and after radiation therapy for a total of 24 weeks. Week 1: 5 mg in the AM, none in the PM; Week 2: 5 mg in the AM, 5 mg in the PM; Week 3: 10 mg in the AM, 5 mg in the PM; Weeks 4-24: 10 mg in the AM, 10 mg in the PM. Should start the same day as radiation therapy, at latest before the fourth radiation treatment.

RADIATION

Whole brain radiation therapy

Whole brain radiation therapy (WBRT) 30 Gy in 10 fractions once per day, 5 days per week for approximately 2 weeks

Trial Locations (220)

10032

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York

10467

Montefiore Medical Center - Moses Campus, The Bronx

11215

New York-Presbyterian/Brooklyn Methodist Hospital, Brooklyn

14642

University of Rochester, Rochester

17822

Geisinger Medical Center, Danville

18512

Northeast Radiation Oncology Center, Dunmore

18711

Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre

19001

Abington Memorial Hospital, Abington

19008

Crozer-Keystone Regional Cancer Center at Broomall, Broomall

19010

Bryn Mawr Hospital, Bryn Mawr

19063

Riddle Memorial Hospital, Media

19096

Lankenau Medical Center, Wynnewood

19107

Thomas Jefferson University Hospital, Philadelphia

19111

Fox Chase Cancer Center, Philadelphia

19114

Aria Health-Torresdale Campus, Philadelphia

19140

Temple University Hospital, Philadelphia

19317

Christiana Care Health System-Concord Health Center, Chadds Ford

19342

Crozer Regional Cancer Center at Brinton Lake, Glen Mills

19611

Reading Hospital, West Reading

19713

Helen F Graham Cancer Center, Newark

19718

Christiana Care Health System-Christiana Hospital, Newark

21014

UM Upper Chesapeake Medical Center, Bel Air

21044

Central Maryland Radiation Oncology in Howard County, Columbia

21061

UM Baltimore Washington Medical Center/Tate Cancer Center, Glen Burnie

21201

University of Maryland/Greenebaum Cancer Center, Baltimore

21204

UM Saint Joseph Medical Center, Towson

21218

MedStar Union Memorial Hospital, Baltimore

23298

Virginia Commonwealth University/Massey Cancer Center, Richmond

26003

Wheeling Hospital/Schiffler Cancer Center, Wheeling

26506

West Virginia University Healthcare, Morgantown

27599

UNC Lineberger Comprehensive Cancer Center, Chapel Hill

28401

NHRMC Radiation Oncology - 16th Street, Wilmington

29307

Greenville Health System Cancer Institute-Spartanburg, Spartanburg

29605

Greenville Health System Cancer Institute-Faris, Greenville

29615

Greenville Health System Cancer Institute-Eastside, Greenville

29646

Self Regional Healthcare, Greenwood

29926

The Radiation Oncology Center-Hilton Head/Bluffton, Hilton Head Island

30303

Grady Health System, Atlanta

30308

Emory University Hospital Midtown, Atlanta

30309

Piedmont Hospital, Atlanta

30322

Emory University Hospital/Winship Cancer Institute, Atlanta

30342

Emory Saint Joseph's Hospital, Atlanta

31404

Memorial Health University Medical Center, Savannah

31405

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler, Savannah

32806

UF Cancer Center at Orlando Health, Orlando

33136

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

33146

UM Sylvester Comprehensive Cancer Center at Coral Gables, Coral Gables

33331

Cleveland Clinic-Weston, Weston

33442

UM Sylvester Comprehensive Cancer Center at Deerfield Beach, Deerfield Beach

33486

Boca Raton Regional Hospital, Boca Raton

35401

Lewis and Faye Manderson Cancer Center, Tuscaloosa

37232

Vanderbilt University/Ingram Cancer Center, Nashville

40536

University of Kentucky/Markey Cancer Center, Lexington

43210

Ohio State University Comprehensive Cancer Center, Columbus

44106

Case Western Reserve University, Cleveland

44111

Cleveland Clinic Cancer Center/Fairview Hospital, Cleveland

44129

University Hospitals Parma Medical Center, Parma

44130

UH Seidman Cancer Center at Southwest General Hospital, Middleburg Heights

44131

Cleveland Clinic Cancer Center Independence, Independence

44136

Cleveland Clinic Cancer Center Strongsville, Strongsville

44145

UHHS-Westlake Medical Center, Westlake

44195

Cleveland Clinic Foundation, Cleveland

44304

Summa Akron City Hospital/Cooper Cancer Center, Akron

44307

Cleveland Clinic Akron General, Akron

46219

Community Cancer Center East, Indianapolis

46227

Community Cancer Center South, Indianapolis

46256

Community Cancer Center North, Indianapolis

46805

Parkview Hospital Randallia, Fort Wayne

48038

Henry Ford Macomb Hospital-Clinton Township, Clinton Township

48043

McLaren Cancer Institute-Macomb, Mount Clemens

48060

McLaren-Port Huron, Port Huron

48098

21st Century Oncology MHP - Troy, Troy

48106

Saint Joseph Mercy Hospital, Ann Arbor

48118

Saint Joseph Mercy Chelsea, Chelsea

48154

Saint Mary Mercy Hospital, Livonia

48183

Henry Ford Cancer Institute-Downriver, Brownstown

48201

Wayne State University/Karmanos Cancer Institute, Detroit

48202

Henry Ford Hospital, Detroit

48322

Henry Ford West Bloomfield Hospital, West Bloomfield

48334

21st Century Oncology MHP - Farmington, Farmington Hills

48341

Saint Joseph Mercy Oakland, Pontiac

48346

21st Century Oncology MHP - Clarkston, Clarkston

McLaren Cancer Institute-Clarkston, Clarkston

48446

McLaren Cancer Institute-Lapeer Region, Lapeer

48503

Genesys Hurley Cancer Institute, Flint

48532

McLaren Cancer Institute-Flint, Flint

48706

McLaren Cancer Institute-Bay City, Bay City

48858

McLaren Cancer Institute-Central Michigan, Mount Pleasant

48867

McLaren Cancer Institute-Owosso, Owosso

49007

West Michigan Cancer Center, Kalamazoo

49085

Lakeland Medical Center Saint Joseph, Saint Joseph

49444

Mercy Health Mercy Campus, Muskegon

49503

Spectrum Health at Butterworth Campus, Grand Rapids

49770

McLaren Cancer Institute-Northern Michigan, Petoskey

52402

Saint Luke's Hospital, Cedar Rapids

53024

Aurora Cancer Care-Grafton, Grafton

53038

UW Cancer Center Johnson Creek, Johnson Creek

53051

Community Memorial Hospital, Menomonee Falls

53066

Aurora Medical Center in Summit, Summit

53142

Aurora Cancer Care-Kenosha South, Kenosha

53211

Ascension Columbia Saint Mary's Water Tower Medical Commons, Milwaukee

53215

Aurora Saint Luke's Medical Center, Milwaukee

53226

Medical College of Wisconsin, Milwaukee

53227

Aurora West Allis Medical Center, West Allis

53233

Aurora Sinai Medical Center, Milwaukee

53295

Zablocki Veterans Administration Medical Center, Milwaukee

53792

University of Wisconsin Hospital and Clinics, Madison

54241

Vince Lombardi Cancer Clinic-Two Rivers, Two Rivers

54311

Aurora BayCare Medical Center, Green Bay

54401

Aspirus Regional Cancer Center, Wausau

54409

Langlade Hospital and Cancer Center, Antigo

54476

Diagnostic and Treatment Center, Weston

54482

Marshfield Clinic Stevens Point Center, Stevens Point

54494

Aspirus UW Cancer Center, Wisconsin Rapids

54601

Gundersen Lutheran Medical Center, La Crosse

Mayo Clinic Health System-Franciscan Healthcare, La Crosse

54701

Mayo Clinic Health System-Eau Claire Clinic, Eau Claire

54904

Vince Lombardi Cancer Clinic - Oshkosh, Oshkosh

55057

Mayo Clinic Radiation Therapy-Northfield, Northfield

55407

Abbott-Northwestern Hospital, Minneapolis

55416

Park Nicollet Clinic - Saint Louis Park, Saint Louis Park

55432

Unity Hospital, Fridley

55905

Mayo Clinic, Rochester

56001

Mayo Clinic Health Systems-Mankato, Mankato

56007

Mayo Clinic Health System in Albert Lea, Albert Lea

58122

Sanford Roger Maris Cancer Center, Fargo

58501

Sanford Bismarck Medical Center, Bismarck

59101

Billings Clinic Cancer Center, Billings

59405

Benefis Healthcare- Sletten Cancer Institute, Great Falls

59804

Community Medical Hospital, Missoula

60048

Condell Memorial Hospital, Libertyville

60134

Northwestern Medicine Cancer Center Delnor, Geneva

60141

Edward Hines Jr VA Hospital, Hines

60153

Loyola University Medical Center, Maywood

60555

Northwestern Medicine Cancer Center Warrenville, Warrenville

60611

Northwestern University, Chicago

60612

John H Stroger Jr Hospital of Cook County, Chicago

60637

University of Chicago Comprehensive Cancer Center, Chicago

61636

Methodist Medical Center of Illinois, Peoria

61637

OSF Saint Francis Medical Center, Peoria

61801

Carle Cancer Center, Urbana

62401

Crossroads Cancer Center, Effingham

62526

Decatur Memorial Hospital, Decatur

62781

Memorial Medical Center, Springfield

62918

SIH Cancer Institute, Carterville

63110

Washington University School of Medicine, St Louis

63129

Siteman Cancer Center-South County, St Louis

63131

Missouri Baptist Medical Center, St Louis

63141

Siteman Cancer Center at West County Hospital, Creve Coeur

Mercy Hospital Saint Louis, St Louis

63376

Siteman Cancer Center at Saint Peters Hospital, City of Saint Peters

63703

Saint Francis Medical Center, Cape Girardeau

64116

North Kansas City Hospital, Kansas City

65807

CoxHealth South Hospital, Springfield

66044

Lawrence Memorial Hospital, Lawrence

66160

University of Kansas Cancer Center, Kansas City

66210

University of Kansas Cancer Center-Overland Park, Overland Park

67214

Ascension Via Christi Hospitals Wichita, Wichita

Wesley Medical Center, Wichita

68198

University of Nebraska Medical Center, Omaha

70112

Tulane University Health Sciences Center, New Orleans

73104

University of Oklahoma Health Sciences Center, Oklahoma City

77030

M D Anderson Cancer Center, Houston

77573

UTMB Cancer Center at Victory Lakes, League City

80113

Swedish Medical Center, Englewood

80304

Rocky Mountain Cancer Centers-Boulder, Boulder

80907

Penrose-Saint Francis Healthcare, Colorado Springs

80909

UCHealth Memorial Hospital Central, Colorado Springs

83301

Saint Luke's Mountain States Tumor Institute-Twin Falls, Twin Falls

83642

Saint Luke's Mountain States Tumor Institute - Meridian, Meridian

83686

Saint Luke's Mountain States Tumor Institute - Nampa, Nampa

83706

Saint Alphonsus Cancer Care Center-Boise, Boise

83712

Saint Luke's Mountain States Tumor Institute, Boise

84112

Huntsman Cancer Institute/University of Utah, Salt Lake City

84405

Ogden Regional Medical Center, Ogden

85234

Banner MD Anderson Cancer Center, Gilbert

85719

Banner University Medical Center - Tucson, Tucson

89502

Renown Regional Medical Center, Reno

90027

Kaiser Permanente Los Angeles Medical Center, Los Angeles

90033

Los Angeles County-USC Medical Center, Los Angeles

USC / Norris Comprehensive Cancer Center, Los Angeles

91010

City of Hope Comprehensive Cancer Center, Duarte

91505

Providence Saint Joseph Medical Center/Disney Family Cancer Center, Burbank

92093

UC San Diego Moores Cancer Center, La Jolla

92103

University of California San Diego, San Diego

94080

Kaiser Permanente Cancer Treatment Center, South San Francisco

94115

California Pacific Medical Center-Pacific Campus, San Francisco

94304

Stanford Cancer Institute Palo Alto, Palo Alto

94589

Sutter Solano Medical Center/Cancer Center, Vallejo

94611

Kaiser Permanente Oakland-Broadway, Oakland

94928

Rohnert Park Cancer Center, Rohnert Park

95051

Kaiser Permanente Medical Center - Santa Clara, Santa Clara

95124

Stanford Cancer Center South Bay, San Jose

95608

Mercy San Juan Medical Center, Carmichael

95661

Sutter Cancer Centers Radiation Oncology Services-Roseville, Roseville

95670

Kaiser Permanente-Rancho Cordova Cancer Center, Rancho Cordova

95678

The Permanente Medical Group-Roseville Radiation Oncology, Roseville

95816

Mercy Cancer Center - Sacramento, Sacramento

Sutter Medical Center Sacramento, Sacramento

97030

Legacy Mount Hood Medical Center, Gresham

97210

Legacy Good Samaritan Hospital and Medical Center, Portland

98101

Virginia Mason Medical Center, Seattle

98902

North Star Lodge Cancer Center at Yakima Valley Memorial Hospital, Yakima

06606

Saint Vincent's Medical Center, Bridgeport

02111

Tufts Medical Center, Boston

01805

Lahey Hospital and Medical Center, Burlington

01854

Lowell General Hospital, Lowell

03820

Wentworth-Douglass Hospital, Dover

03756

Dartmouth Hitchcock Medical Center, Lebanon

57117-5134

Sanford USD Medical Center - Sioux Falls, Sioux Falls

77555-0565

University of Texas Medical Branch, Galveston

05819

Norris Cotton Cancer Center-North, Saint Johnsbury

H2L 4M1

CHUM - Hopital Notre-Dame, Montreal

H2W 1S6

McGill University Department of Oncology, Montreal

H2X 3E4

CHUM - Centre Hospitalier de l'Universite de Montreal, Montreal

H3H 2R9

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

G1R 2J6

CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ), Québec

J1H 5N4

Centre Hospitalier Universitaire de Sherbrooke-Fleurimont, Sherbrooke

S4T 7T1

Allan Blair Cancer Centre, Regina

S7N 4H4

Saskatoon Cancer Centre, Saskatoon

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

NRG Oncology

OTHER