Memantine Hydrochloride and Whole-Brain Radiotherapy With or Without Hippocampal Avoidance in Reducing Neurocognitive Decline in Patients With Brain Metastases
A Randomized Phase III Trial of Memantine and Whole-Brain Radiotherapy With or Without Hippocampal Avoidance in Patients With Brain Metastases
3 other identifiers
interventional
518
2 countries
220
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2015
Typical duration for phase_3
220 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2015
CompletedFirst Posted
Study publicly available on registry
February 10, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 26, 2019
CompletedResults Posted
Study results publicly available
March 6, 2020
CompletedApril 23, 2025
February 1, 2020
2.8 years
February 5, 2015
January 14, 2020
April 8, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Time to Neurocognitive Failure
Neurocognitive failure is defined as the first failure, defined as a neurocognitive decline using the reliable change index (RCI) on at least one of the following assessments or parts of : Hopkins Verbal Learning Test - Revised (HVLT-R), Trail Making Test (TMT), or Controlled Oral Word Association (COWA). The HVLT-R has 3 parts that were analyzed separately for decline: Total Recall, Delayed Recall, and Delayed Recognition. The TMT has 2 parts that were analyzed separately: Part A and Part B. Neurocognitive failure rate is estimated using the cumulative incidence method. Analysis was planned to occur after 233 events were reported. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Six-month rates are provided.Analysis was planned to occur after 233 events were reported.
From randomization to last follow-up. Maximum follow-up was 15.6 months.
Secondary Outcomes (22)
Change From Baseline in the Hopkins Verbal Learning Test -Revised (HVLT-R) Total Recall Score (Neurocognitive Decline)
Baseline, 2, 4, 6, and 12 months
Change From Baseline in the Hopkins Verbal Learning Test -Revised (HVLT-R) Delayed Recall Score (Neurocognitive Decline)
Baseline, 2, 4, 6, and 12 months
Change From Baseline in the Hopkins Verbal Learning Test -Revised (HVLT-R) Delayed Recognition (Neurocognitive Decline)
Baseline, 2, 4, 6, and 12 months
Change From Baseline in the Trail Making Test (TMT) Part A (Neurocognitive Decline)
Baseline, 2, 4, 6, and 12 months
Change From Baseline in the Trail Making Test (TMT) Part B (Neurocognitive Decline)
Baseline, 2, 4, 6, and 12 months
- +17 more secondary outcomes
Other Outcomes (4)
Anxiety/Depression Measured Using the EQ-5D-5L
Up to 12 months
Effect of Radiation Therapy Oncology Group (RTOG) RPA and the Diagnosis-specific Graded Prognostic Assessment (DSGPA) on Neurocognitive Function
Up to 12 months
Effect of White Matter Injury and Hippocampal Volume on Neurocognitive Function
Up to 12 months
- +1 more other outcomes
Study Arms (2)
WBRT + Memantine
EXPERIMENTALWhole brain radiation therapy (WBRT) and memantine
HA-WBRT/IMRT+ Memantine
EXPERIMENTALWhole brain radiation therapy with hippocampal avoidance (HA-WBRT) using intensity modulated radiation therapy (IMRT) and memantine
Interventions
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.
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.
Whole brain radiation therapy (WBRT) 30 Gy in 10 fractions once per day, 5 days per week for approximately 2 weeks
Eligibility Criteria
You may qualify if:
- PRIOR TO STEP 1 REGISTRATION:
- Brain metastases outside a 5-mm margin around either hippocampus must be visible on contrast-enhanced magnetic resonance imaging (MRI) performed =\< 21 days prior to Step 1 registration; an allowed exception, regarding ability to image brain metastases, would be that patients who had undergone radiosurgery or surgical resection and are planning adjuvant WBRT do not have to have visible disease but do need a pre-surgery MRI or computed tomography (CT) scan demonstrating brain metastases; however, the brain metastases could not have been within 5 mm of either hippocampus
- Patients must have a gadolinium contrast-enhanced three-dimensional spoiled gradient (SPGR), magnetization-prepared rapid gradient echo (MP-RAGE), or turbo field echo (TFE) axial MRI scan with standard axial and coronal gadolinium contrast-enhanced T1-weighted sequence and axial T2/FLAIR sequence acquisitions; to yield acceptable image quality, the gadolinium contrast-enhanced three-dimensional SPGR, MP-RAGE, or TFE axial MRI scan should use the smallest possible axial slice thickness not exceeding 1.5 mm; the associated coronal and sagittal contrast-enhanced T1 sequences can be up to 2.5 mm in slice thickness; this MRI must be obtained =\< 21 days prior to step 1 registration; the vendor specific MRI protocols are available for download from the Alzheimer's Disease Neuroimaging Initiative (ADNI)
- Patients must provide study-specific informed consent prior to registration
- PRIOR TO STEP 2 REGISTRATION:
- The following baseline neurocognitive assessments must be completed prior to Step 2 registration: HVLT-R, TMT, and COWA;
- Pathologically (histologically or cytologically) proven diagnosis of solid tumor malignancy within 5 years prior to Step 2 registration
- History and physical examination within 28 days prior to Step 2 registration
- Karnofsky performance status of \>= 70 within 28 days prior to Step 2 registration
- Serum creatinine =\< 3 mg/dL (265 umol/L) and creatinine clearance \>= 30 ml/min
- Blood urea nitrogen (BUN) within institutional upper limit of normal (e.g. \< 20 mg/dL)
- Total bilirubin =\< 2.5 mg/dL (43 umol/L)
- Patients may have had prior therapy for brain metastasis, including radiosurgery and surgical resection; patients must have completed prior therapy by at least 14 days prior to Step 2 for surgical resection and 7 days for radiosurgery
- Negative serum pregnancy test (in women of childbearing potential) =\< 14 days prior to Step 2; women of childbearing potential and men who are sexually active must practice adequate contraception while on study
- Patients who are primary English or French speakers are eligible
You may not qualify if:
- Prior external beam radiation therapy to the brain or whole brain radiation therapy
- Planned cytotoxic chemotherapy during the WBRT only; patients may have had prior chemotherapy
- Radiographic evidence of hydrocephalus or other architectural distortion of the ventricular system, including placement of external ventricular drain or ventriculoperitoneal shunt
- Severe, active co-morbidity defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- Transmural myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Chronic obstructive pulmonary disease exacerbation or other acute respiratory illness precluding study therapy at the time of registration
- Severe hepatic disease defined as a diagnosis of Child-Pugh class B or C hepatic disease
- Renal tubular acidosis or metabolic acidosis
- Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD)4 count \< 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count \>= 200 cells/microliter within 30 days prior to registration; Note also that HIV testing is not required for eligibility for this protocol
- Pregnant or lactating women, or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
- Prior allergic reaction to memantine (memantine hydrochloride)
- Current alcohol or drug abuse (may exacerbate lethargy/dizziness with memantine)
- Intractable seizures while on adequate anticonvulsant therapy-more than 1 seizure per month for the past 2 months
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NRG Oncologylead
- National Cancer Institute (NCI)collaborator
Study Sites (220)
Lewis and Faye Manderson Cancer Center
Tuscaloosa, Alabama, 35401, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
Banner University Medical Center - Tucson
Tucson, Arizona, 85719, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505, United States
Mercy San Juan Medical Center
Carmichael, California, 95608, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027, United States
Los Angeles County-USC Medical Center
Los Angeles, California, 90033, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Kaiser Permanente Oakland-Broadway
Oakland, California, 94611, United States
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304, United States
Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova, California, 95670, United States
Rohnert Park Cancer Center
Rohnert Park, California, 94928, United States
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, 95661, United States
The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California, 95678, United States
Mercy Cancer Center - Sacramento
Sacramento, California, 95816, United States
Sutter Medical Center Sacramento
Sacramento, California, 95816, United States
University of California San Diego
San Diego, California, 92103, United States
California Pacific Medical Center-Pacific Campus
San Francisco, California, 94115, United States
Stanford Cancer Center South Bay
San Jose, California, 95124, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051, United States
Kaiser Permanente Cancer Treatment Center
South San Francisco, California, 94080, United States
Sutter Solano Medical Center/Cancer Center
Vallejo, California, 94589, United States
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, 80304, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907, United States
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, 80909, United States
Swedish Medical Center
Englewood, Colorado, 80113, United States
Saint Vincent's Medical Center
Bridgeport, Connecticut, 06606, United States
Helen F Graham Cancer Center
Newark, Delaware, 19713, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
Boca Raton Regional Hospital
Boca Raton, Florida, 33486, United States
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, 33146, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, 33442, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
UF Cancer Center at Orlando Health
Orlando, Florida, 32806, United States
Cleveland Clinic-Weston
Weston, Florida, 33331, United States
Grady Health System
Atlanta, Georgia, 30303, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342, United States
Memorial Health University Medical Center
Savannah, Georgia, 31404, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706, United States
Saint Luke's Mountain States Tumor Institute
Boise, Idaho, 83712, United States
Saint Luke's Mountain States Tumor Institute - Meridian
Meridian, Idaho, 83642, United States
Saint Luke's Mountain States Tumor Institute - Nampa
Nampa, Idaho, 83686, United States
Saint Luke's Mountain States Tumor Institute-Twin Falls
Twin Falls, Idaho, 83301, United States
SIH Cancer Institute
Carterville, Illinois, 62918, United States
Northwestern University
Chicago, Illinois, 60611, United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Crossroads Cancer Center
Effingham, Illinois, 62401, United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134, United States
Edward Hines Jr VA Hospital
Hines, Illinois, 60141, United States
Condell Memorial Hospital
Libertyville, Illinois, 60048, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636, United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
Memorial Medical Center
Springfield, Illinois, 62781, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555, United States
Parkview Hospital Randallia
Fort Wayne, Indiana, 46805, United States
Community Cancer Center East
Indianapolis, Indiana, 46219, United States
Community Cancer Center South
Indianapolis, Indiana, 46227, United States
Community Cancer Center North
Indianapolis, Indiana, 46256, United States
Saint Luke's Hospital
Cedar Rapids, Iowa, 52402, United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
Lawrence Memorial Hospital
Lawrence, Kansas, 66044, United States
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, 66210, United States
Ascension Via Christi Hospitals Wichita
Wichita, Kansas, 67214, United States
Wesley Medical Center
Wichita, Kansas, 67214, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
MedStar Union Memorial Hospital
Baltimore, Maryland, 21218, United States
UM Upper Chesapeake Medical Center
Bel Air, Maryland, 21014, United States
Central Maryland Radiation Oncology in Howard County
Columbia, Maryland, 21044, United States
UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland, 21061, United States
UM Saint Joseph Medical Center
Towson, Maryland, 21204, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805, United States
Lowell General Hospital
Lowell, Massachusetts, 01854, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106, United States
McLaren Cancer Institute-Bay City
Bay City, Michigan, 48706, United States
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan, 48183, United States
Saint Joseph Mercy Chelsea
Chelsea, Michigan, 48118, United States
21st Century Oncology MHP - Clarkston
Clarkston, Michigan, 48346, United States
McLaren Cancer Institute-Clarkston
Clarkston, Michigan, 48346, United States
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, 48038, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
21st Century Oncology MHP - Farmington
Farmington Hills, Michigan, 48334, United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503, United States
McLaren Cancer Institute-Flint
Flint, Michigan, 48532, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
McLaren Cancer Institute-Lapeer Region
Lapeer, Michigan, 48446, United States
Saint Mary Mercy Hospital
Livonia, Michigan, 48154, United States
McLaren Cancer Institute-Macomb
Mount Clemens, Michigan, 48043, United States
McLaren Cancer Institute-Central Michigan
Mount Pleasant, Michigan, 48858, United States
Mercy Health Mercy Campus
Muskegon, Michigan, 49444, United States
McLaren Cancer Institute-Owosso
Owosso, Michigan, 48867, United States
McLaren Cancer Institute-Northern Michigan
Petoskey, Michigan, 49770, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, 48341, United States
McLaren-Port Huron
Port Huron, Michigan, 48060, United States
Lakeland Medical Center Saint Joseph
Saint Joseph, Michigan, 49085, United States
21st Century Oncology MHP - Troy
Troy, Michigan, 48098, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322, United States
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, 56007, United States
Unity Hospital
Fridley, Minnesota, 55432, United States
Mayo Clinic Health Systems-Mankato
Mankato, Minnesota, 56001, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Mayo Clinic Radiation Therapy-Northfield
Northfield, Minnesota, 55057, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376, United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141, United States
North Kansas City Hospital
Kansas City, Missouri, 64116, United States
CoxHealth South Hospital
Springfield, Missouri, 65807, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Siteman Cancer Center-South County
St Louis, Missouri, 63129, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, 59405, United States
Community Medical Hospital
Missoula, Montana, 59804, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Renown Regional Medical Center
Reno, Nevada, 89502, United States
Wentworth-Douglass Hospital
Dover, New Hampshire, 03820, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
New York-Presbyterian/Brooklyn Methodist Hospital
Brooklyn, New York, 11215, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032, United States
University of Rochester
Rochester, New York, 14642, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
NHRMC Radiation Oncology - 16th Street
Wilmington, North Carolina, 28401, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122, United States
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, 44304, United States
Cleveland Clinic Akron General
Akron, Ohio, 44307, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, 44111, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Cleveland Clinic Cancer Center Independence
Independence, Ohio, 44131, United States
UH Seidman Cancer Center at Southwest General Hospital
Middleburg Heights, Ohio, 44130, United States
University Hospitals Parma Medical Center
Parma, Ohio, 44129, United States
Cleveland Clinic Cancer Center Strongsville
Strongsville, Ohio, 44136, United States
UHHS-Westlake Medical Center
Westlake, Ohio, 44145, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Legacy Mount Hood Medical Center
Gresham, Oregon, 97030, United States
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, 97210, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Crozer-Keystone Regional Cancer Center at Broomall
Broomall, Pennsylvania, 19008, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010, United States
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, 19317, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Northeast Radiation Oncology Center
Dunmore, Pennsylvania, 18512, United States
Crozer Regional Cancer Center at Brinton Lake
Glen Mills, Pennsylvania, 19342, United States
Riddle Memorial Hospital
Media, Pennsylvania, 19063, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Aria Health-Torresdale Campus
Philadelphia, Pennsylvania, 19114, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Reading Hospital
West Reading, Pennsylvania, 19611, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096, United States
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, 29605, United States
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina, 29615, United States
Self Regional Healthcare
Greenwood, South Carolina, 29646, United States
The Radiation Oncology Center-Hilton Head/Bluffton
Hilton Head Island, South Carolina, 29926, United States
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, 29307, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
University of Texas Medical Branch
Galveston, Texas, 77555-0565, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
UTMB Cancer Center at Victory Lakes
League City, Texas, 77573, United States
Ogden Regional Medical Center
Ogden, Utah, 84405, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
Norris Cotton Cancer Center-North
Saint Johnsbury, Vermont, 05819, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, 98902, United States
West Virginia University Healthcare
Morgantown, West Virginia, 26506, United States
Wheeling Hospital/Schiffler Cancer Center
Wheeling, West Virginia, 26003, United States
Langlade Hospital and Cancer Center
Antigo, Wisconsin, 54409, United States
Mayo Clinic Health System-Eau Claire Clinic
Eau Claire, Wisconsin, 54701, United States
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311, United States
UW Cancer Center Johnson Creek
Johnson Creek, Wisconsin, 53038, United States
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, 54601, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
Community Memorial Hospital
Menomonee Falls, Wisconsin, 53051, United States
Ascension Columbia Saint Mary's Water Tower Medical Commons
Milwaukee, Wisconsin, 53211, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233, United States
Zablocki Veterans Administration Medical Center
Milwaukee, Wisconsin, 53295, United States
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, 54904, United States
Marshfield Clinic Stevens Point Center
Stevens Point, Wisconsin, 54482, United States
Aurora Medical Center in Summit
Summit, Wisconsin, 53066, United States
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, 54241, United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227, United States
Diagnostic and Treatment Center
Weston, Wisconsin, 54476, United States
Aspirus UW Cancer Center
Wisconsin Rapids, Wisconsin, 54494, United States
CHUM - Hopital Notre-Dame
Montreal, Quebec, H2L 4M1, Canada
McGill University Department of Oncology
Montreal, Quebec, H2W 1S6, Canada
CHUM - Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 3E4, Canada
The Research Institute of the McGill University Health Centre (MUHC)
Montreal, Quebec, H3H 2R9, Canada
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
Québec, Quebec, G1R 2J6, Canada
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke, Quebec, J1H 5N4, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4, Canada
Related Publications (1)
Brown PD, Gondi V, Pugh S, Tome WA, Wefel JS, Armstrong TS, Bovi JA, Robinson C, Konski A, Khuntia D, Grosshans D, Benzinger TLS, Bruner D, Gilbert MR, Roberge D, Kundapur V, Devisetty K, Shah S, Usuki K, Anderson BM, Stea B, Yoon H, Li J, Laack NN, Kruser TJ, Chmura SJ, Shi W, Deshmukh S, Mehta MP, Kachnic LA; for NRG Oncology. Hippocampal Avoidance During Whole-Brain Radiotherapy Plus Memantine for Patients With Brain Metastases: Phase III Trial NRG Oncology CC001. J Clin Oncol. 2020 Apr 1;38(10):1019-1029. doi: 10.1200/JCO.19.02767. Epub 2020 Feb 14.
PMID: 32058845RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Wendy Seiferheld
- Organization
- NRG Oncology
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Brown
NRG Oncology
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2015
First Posted
February 10, 2015
Study Start
July 1, 2015
Primary Completion
April 30, 2018
Study Completion
August 26, 2019
Last Updated
April 23, 2025
Results First Posted
March 6, 2020
Record last verified: 2020-02