Memantine in Preventing Side Effects in Patients Undergoing Whole-Brain Radiation Therapy for Brain Metastases From Solid Tumors
A Randomized, Phase III, Double-Blind, Placebo-Controlled Trial of Memantine for Prevention of Cognitive Dysfunction in Patients Receiving Whole-Brain Radiotherapy
3 other identifiers
interventional
554
2 countries
235
Brief Summary
RATIONALE: Memantine may be able to decrease side effects caused by whole-brain radiation therapy. It is not yet known if memantine is effective in preventing side effects caused by whole-brain radiation therapy. PURPOSE: This randomized phase III trial is studying memantine to see how well it works compared to a placebo in preventing side effects caused by whole-brain radiation therapy in patients with brain metastases from solid tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2008
Longer than P75 for phase_3
235 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
December 1, 2007
CompletedFirst Posted
Study publicly available on registry
December 4, 2007
CompletedStudy Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedResults Posted
Study results publicly available
July 21, 2017
CompletedAugust 21, 2017
July 1, 2017
3.1 years
December 1, 2007
April 19, 2016
July 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the Hopkins Verbal Learning Test - Revised for Delayed Recall (HVLT-R-delayed Recall) at 24 Weeks
The HVLT-R consists of 3 parts. Free call has a range of 0 to 36, delayed recall has a range from 0 to 12, and delayed recognition has a range of -12 to 12. Higher scores indicating better function in all 3 parts. Standardized scores are used by calculating an average standardized z score for each part of the HVLT-R. Change is calculated by subtracting baseline value from 24-week value. Imputation methods were used to determine values for all alive patients missing the 24 week assessment. This tool is being used to measure cognitive function, specifically memory.
Baseline and 24 weeks from the start of drug treatment
Secondary Outcomes (5)
Change in the Hopkins Verbal Learning Test - Revised for Delayed Recall (HVLT-R-delayed Recall) at 8, 16, and 52 Weeks
Baseline, 8, 16, and 52 weeks from the start of drug treatment
Median Time to Neurocognitive Failure
Baseline to 12 months from the start of drug treatment
Change in Functional Assessment of Cancer Therapy With Brain Subscale (FACT-Br) at 24 Weeks
Baseline and 24 weeks from start of treatment
Median Progression-free Survival Time
From randomization to date of progression, death or last follow-up. Analysis occurs at the same time as the primary outcome. Patients are followed until death and all follow-up collected at time of analysis is used.
Overall Survival
From randomization to date of death or last follow-up. Analysis occurs at the same time as the primary outcome. Patients are followed until death and all follow-up collected at time of analysis is used.
Study Arms (2)
WBRT+Memantine
EXPERIMENTALWhole brain radiation therapy (WBRT) and memantine
WBRT+Placebo
ACTIVE COMPARATORWhole brain radiation therapy (WBRT) and placebo
Interventions
Patients began taking memantine(by mouth) while receiving radiation therapy. Patients continued taking memantine for 24 weeks or until doctor thinks it is in their best interest to stop. They started with 5 mg once a day. After a week dose increased to 5 mg twice a day. At week 3, dose increased to 10 mg in the morning and 5 mg in the evening. Weeks 4-24, dose was 10 mg twice a day.
Patients began taking placebo(by mouth) while receiving radiation therapy. Patients continued taking placebo for 24 weeks or until doctor thinks it is in their best interest to stop. They started with 5 mg once a day. After a week dose increased to 5 mg twice a day. At week 3, dose increased to 10 mg in the morning and 5 mg in the evening. Weeks 4-24, dose was 10 mg twice a day.
Whole brain radiation therapy (WBRT) once a day (2.5Gy), five days a week (Monday to Friday) for three weeks, for total fifteen treatments and 37.5 Gy
Eligibility Criteria
You may qualify if:
- Karnofsky performance status 70-100%
- Serum creatinine ≤ 3 mg/dL and creatinine clearance ≥ 30 mL/min
- Total bilirubin ≤ 2.5 mg/dL
- Blood urea nitrogen (BUN) \< 20 mg/dL
- Mini-mental status exam score ≥ 18
- Negative serum pregnancy test
- Fertile patients must practice adequate contraception
You may not qualify if:
- 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 respiratory illness requiring hospitalization or precluding study therapy at the time of registration
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- Pregnant or lactating women
- Prior allergic reaction to memantine hydrochloride
- Current alcohol or drug abuse
- Intractable seizures while on adequate anticonvulsant therapy (i.e., more than one seizure per month for the past 2 months)
- PRIOR CONCURRENT THERAPY:
- At least 14 days but no more than 56 days since prior therapy for brain metastasis, including radiosurgery and surgical resection
- No systemic chemotherapy for 14 days prior, during, or for 14 days after completion of whole-brain radiotherapy (WBRT)
- Prior cranial radiotherapy
- Patients may have received up to 3 prior WBRT treatments and still be registered and randomized on the protocol provided WBRT parameters meet protocol requirements
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Radiation Therapy Oncology Grouplead
- National Cancer Institute (NCI)collaborator
- NRG Oncologycollaborator
Study Sites (235)
MBCCOP - Gulf Coast
Mobile, Alabama, 36604, United States
Providence Cancer Center at Providence Hospital
Mobile, Alabama, 36608, United States
Arizona Oncology Services Foundation
Phoenix, Arizona, 85013, United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259-5499, United States
Arizona Oncology - Tucson
Tucson, Arizona, 85704, United States
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, 85724-5024, United States
Auburn Radiation Oncology
Auburn, California, 95603, United States
Providence Saint Joseph Medical Center - Burbank
Burbank, California, 91505, United States
Radiation Oncology Centers - Cameron Park
Cameron Park, California, 95682, United States
Mercy Cancer Center at Mercy San Juan Medical Center
Carmichael, California, 95608, United States
Enloe Cancer Center at Enloe Medical Center
Chico, California, 95926, United States
Cancer Care Center at John Muir Health - Concord Campus
Concord, California, 94524-4110, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000, United States
Glendale Adventist Medical Center
Glendale, California, 91206, United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, 92093-0658, United States
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90089-9181, United States
St. Joseph Hospital Regional Cancer Center - Orange
Orange, California, 92868, United States
Radiation Oncology Center - Roseville
Roseville, California, 95661, United States
Radiological Associates of Sacramento Medical Group, Incorporated
Sacramento, California, 95815, United States
University of California Davis Cancer Center
Sacramento, California, 95817, United States
Mercy General Hospital
Sacramento, California, 95819, United States
Stanford Cancer Center
Stanford, California, 94305-5824, United States
Emanuel Regional Cancer Services at Emanuel Medical Center
Turlock, California, 95382, United States
Solano Radiation Oncology Center
Vacaville, California, 95687, United States
John Muir/Mt. Diablo Comprehensive Cancer Center
Walnut Creek, California, 94598, United States
Rocky Mountain Cancer Centers - Aurora
Aurora, Colorado, 80012, United States
Rocky Mountain Cancer Centers - Colorado Springs
Colorado Springs, Colorado, 80909, United States
Poudre Valley Radiation Oncology
Fort Collins, Colorado, 80528, United States
Yale Cancer Center
New Haven, Connecticut, 06520-8028, United States
CCOP - Christiana Care Health Services
Newark, Delaware, 19713, United States
Washington Cancer Institute at Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
University of Florida Shands Cancer Center
Gainesville, Florida, 32610-0232, United States
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, 32207, United States
Integrated Community Oncology Network at Southside Cancer Center
Jacksonville, Florida, 32207, United States
Baptist Medical Center South
Jacksonville, Florida, 32258, United States
Integrated Community Oncology Network
Jacksonville Beach, Florida, 32250, United States
Integrated Community Oncology Network - Orange Park
Orange Park, Florida, 32073, United States
Florida Institute of Research, Medicine and Surgery Cancer Center
Orlando, Florida, 32806, United States
Florida Cancer Center - Palatka
Palatka, Florida, 32177, United States
Flagler Cancer Center
Saint Augustine, Florida, 32086, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322, United States
John B. Amos Cancer Center
Columbus, Georgia, 31904, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, 30033, United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501, United States
Northwest Community Hospital
Arlington Heights, Illinois, 60005, United States
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, 60612-3785, United States
Cancer Institute at St. John's Hospital
Springfield, Illinois, 62702, United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801, United States
Saint John's Cancer Center at Saint John's Medical Center
Anderson, Indiana, 46016, United States
Bloomington Hospital Regional Cancer Institute
Bloomington, Indiana, 47403, United States
Radiation Oncology Associates Southwest
Fort Wayne, Indiana, 46804, United States
Parkview Regional Cancer Center at Parkview Health
Fort Wayne, Indiana, 46805, United States
Center for Cancer Care at Goshen General Hospital
Goshen, Indiana, 46526, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202-5289, United States
Methodist Cancer Center at Methodist Hospital
Indianapolis, Indiana, 46202, United States
Central Indiana Cancer Centers - East
Indianapolis, Indiana, 46219, United States
Community Regional Cancer Care at Community Hospital East
Indianapolis, Indiana, 46219, United States
Community Regional Cancer Care at Community Hospital North
Indianapolis, Indiana, 46256, United States
Cancer Center at Ball Memorial Hospital
Muncie, Indiana, 47303-3499, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, 52242-1002, United States
Kansas City Cancer Centers - Southwest
Overland Park, Kansas, 66210, United States
Lucille P. Markey Cancer Center at University of Kentucky
Lexington, Kentucky, 40536-0093, United States
Norton Suburban Hospital
Louisville, Kentucky, 40207, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
St. Agnes Hospital Cancer Center
Baltimore, Maryland, 21229, United States
Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
Baltimore, Maryland, 21237, United States
Good Samaritan Hospital of Maryland
Baltimore, Maryland, 21239, United States
Central Maryland Oncology Center
Columbia, Maryland, 21044, United States
Tate Cancer Center at Baltimore Washington Medical Center
Glen Burnie, Maryland, 21061, United States
Cancer Institute at St. Joseph Medical Center
Towson, Maryland, 21204, United States
Boston University Cancer Research Center
Boston, Massachusetts, 02118, United States
Charach Cancer Center at Huron Valley - Sinai Hospital
Commerce, Michigan, 48382, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, 48202, United States
Great Lakes Cancer Institute at McLaren Regional Medical Center
Flint, Michigan, 48532, United States
CCOP - Grand Rapids
Grand Rapids, Michigan, 49503, United States
St. Mary Mercy Hospital
Livonia, Michigan, 48154, United States
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, 48073, United States
Albert Lea Cancer Center at Albert Lea Medical Center
Albert Lea, Minnesota, 56007, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, 55432, United States
Immanuel St. Joseph's
Mankato, Minnesota, 56002, United States
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota, 55109, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, 55422-2900, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
CentraCare Clinic - River Campus
Saint Cloud, Minnesota, 56303, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, 39581, United States
Kansas City Cancer Centers - South
Kansas City, Missouri, 64131, United States
Kansas City Cancer Centers - North
Kansas City, Missouri, 64154, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, 65807, United States
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, 63141, United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101, United States
Northern Rockies Radiation Oncology Center
Billings, Montana, 59101, United States
Billings Clinic - Downtown
Billings, Montana, 59107-7000, United States
Methodist Estabrook Cancer Center
Omaha, Nebraska, 68114, United States
Nebraska Medical Center
Omaha, Nebraska, 68198, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106, United States
Renown Institute for Cancer at Renown Regional Medical Center
Reno, Nevada, 89502, United States
Payson Center for Cancer Care at Concord Hospital
Concord, New Hampshire, 03301, United States
Elliot Regional Cancer Center at Elliot Hospital
Manchester, New Hampshire, 03103, United States
Ocean Medical Center at Meridian Health
Brick, New Jersey, 08724, United States
Cancer Institute of New Jersey at Cooper University Hospital - Camden
Camden, New Jersey, 08103, United States
Trinitas Comprehensive Cancer Center at Trinitas Hospital
Elizabeth, New Jersey, 07207, United States
Princeton Radiation Oncology Center
Jamesburg, New Jersey, 08831, United States
Saint Peter's University Hospital
New Brunswick, New Jersey, 08901, United States
University Medical Center at Princeton
Princeton, New Jersey, 08540-3298, United States
J. Phillip Citta Regional Cancer Center at Community Medical Center
Toms River, New Jersey, 08755, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, 08043, United States
Lovelace Medical Center - Downtown
Albuquerque, New Mexico, 87102, United States
Radiation Oncology Associates, PA
Albuquerque, New Mexico, 87109, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87131-5636, United States
New York Oncology Hematology, PC at Albany Regional Cancer Care
Albany, New York, 12206, United States
Veterans Affairs Medical Center - Albany
Albany, New York, 12208, United States
New York Methodist Hospital
Brooklyn, New York, 11215, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001, United States
Sands Cancer Center
Canandaigua, New York, 14424, United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030, United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040, United States
Highland Hospital of Rochester
Rochester, New York, 14620, United States
Lipson Cancer and Blood Center at Rochester General Hospital
Rochester, New York, 14621, United States
University Radiation Oncology at Parkridge Hospital
Rochester, New York, 14626, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, 14642, United States
Mission Hospitals - Memorial Campus
Asheville, North Carolina, 28801, United States
New Hanover Radiation Oncology, PA
Wilmington, North Carolina, 28401, United States
Trinity CancerCare Center
Minot, North Dakota, 58701, United States
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, 44307, United States
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, 44309-2090, United States
Barberton Citizens Hospital
Barberton, Ohio, 44203, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, 45267, United States
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland, Ohio, 44111, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195, United States
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210-1240, United States
Cleveland Clinic Cancer Center
Independence, Ohio, 44131, United States
Northwest Ohio Oncology Center
Maumee, Ohio, 43537-1839, United States
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, 44124, United States
St. Charles Mercy Hospital
Oregon, Ohio, 43616, United States
Cancer Care Center, Incorporated
Salem, Ohio, 44460, United States
North Coast Cancer Care, Incorporated
Sandusky, Ohio, 44870, United States
Flower Hospital Cancer Center
Sylvania, Ohio, 43560, United States
Medical University of Ohio Cancer Center
Toledo, Ohio, 43614, United States
CCOP - Toledo Community Hospital
Toledo, Ohio, 43617, United States
St. Anne Mercy Hospital
Toledo, Ohio, 43623, United States
Precision Radiotherapy at University Pointe
West Chester, Ohio, 45069, United States
Cancer Treatment Center
Wooster, Ohio, 44691, United States
Cleveland Clinic - Wooster
Wooster, Ohio, 44691, United States
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, 73104, United States
Willamette Valley Cancer Center - Eugene
Eugene, Oregon, 97401, United States
Three Rivers Community Hospital
Grants Pass, Oregon, 97527, United States
Dubs Cancer Center at Rogue Valley Medical Center
Medford, Oregon, 97504, United States
Providence Cancer Center at PMCC
Medford, Oregon, 97504, United States
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
UPMC Cancer Center at Beaver Medical Center
Beaver, Pennsylvania, 15009, United States
St. Luke's Cancer Network at St. Luke's Hospital
Bethlehem, Pennsylvania, 18015, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010, United States
UPMC Cancer Center at Jefferson Regional Medical Center
Clairton, Pennsylvania, 15025, United States
Cancer Center at Clarion Hospital
Clarion, Pennsylvania, 16214, United States
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, 17822-0001, United States
Delaware County Regional Cancer Center at Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, 19026, United States
Northeast Radiation Oncology Center
Dunmore, Pennsylvania, 18512, United States
Adams Cancer Center
Gettysburg, Pennsylvania, 17325, United States
UPMC Cancer Center - Arnold Palmer Pavilion
Greensburg, Pennsylvania, 15601, United States
Cherry Tree Cancer Center
Hanover, Pennsylvania, 17331, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
UPMC Cancer Center at the John P. Murtha Pavilion
Johnstown, Pennsylvania, 15901, United States
UPMC Cancer Center at UPMC McKeesport
McKeesport, Pennsylvania, 15132, United States
UPMC - Moon
Moon Township, Pennsylvania, 15108, United States
UPMC Cancer Center - Natrona Heights
Natrona Heights, Pennsylvania, 15065, United States
Jameson Memorial Hospital - North Campus
New Castle, Pennsylvania, 16105, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, 19111-2497, United States
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, 19141, United States
UPMC - Shadyside
Pittsburgh, Pennsylvania, 15213-2582, United States
UPMC Cancer Center at Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213, United States
UPMC Cancer Center at UPMC St. Margaret
Pittsburgh, Pennsylvania, 15215, United States
UPMC Cancer Center at UPMC Passavant
Pittsburgh, Pennsylvania, 15237, United States
UPMC Cancer Center - Upper St. Clair
Pittsburgh, Pennsylvania, 15243, United States
UPMC Cancer Center at UPMC Northwest
Seneca, Pennsylvania, 16346, United States
UPMC Cancer Center - Uniontown
Uniontown, Pennsylvania, 15401, United States
Washington Hospital Cancer Center
Washington, Pennsylvania, 15301, United States
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, 19096, United States
York Cancer Center at Apple Hill Medical Center
York, Pennsylvania, 17405, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, 29425, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303, United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57701, United States
Texas Oncology, PA at Texas Cancer Center - Arlington South
Arlington, Texas, 76014, United States
Texas Oncology, PA at Harris Center HEB
Bedford, Texas, 76022, United States
Medical City Dallas Hospital
Dallas, Texas, 75230, United States
Texas Oncology, PA at Texas Cancer Center Dallas Southwest
Dallas, Texas, 75237, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, 75390, United States
Texas Oncology, PA at Texas Cancer Center - Denton South
Denton, Texas, 76210, United States
Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital
Fort Worth, Texas, 76104, United States
Longview Cancer Center
Longview, Texas, 75601, United States
West Texas Cancer Center
Odessa, Texas, 79761, United States
Cancer Care Centers of South Texas - Northeast
San Antonio, Texas, 78217, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900, United States
Texas Oncology, PA at Texas Cancer Center - Sherman
Sherman, Texas, 75090, United States
Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land
Sugar Land, Texas, 77479, United States
Tyler Cancer Center
Tyler, Texas, 75702, United States
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Murray, Utah, 84157, United States
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
Ogden, Utah, 84403, United States
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, 84106, United States
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, 84112, United States
Dixie Regional Medical Center - East Campus
St. George, Utah, 84770, United States
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, 05401, United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22908, United States
Sentara Cancer Institute at Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, 99202, United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, 98902, United States
Schiffler Cancer Center at Wheeling Hospital
Wheeling, West Virginia, 26003, United States
Theda Care Cancer Institute
Appleton, Wisconsin, 54911, United States
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54307-3508, United States
Franciscan Skemp Healthcare - La Crosse Campus
La Crosse, Wisconsin, 54601, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164, United States
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, 54143, United States
Community Memorial Hospital Cancer Care Center
Menomonee Falls, Wisconsin, 53051, United States
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, 53226, United States
All Saints Cancer Center at Wheaton Franciscan Healthcare
Racine, Wisconsin, 53405, United States
University of Wisconcin Cancer Center at Aspirus Wausau Hospital
Wausau, Wisconsin, 54401, United States
West Allis Memorial Hospital
West Allis, Wisconsin, 53227, United States
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V8, Canada
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, N6A 4L6, Canada
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 2M4, Canada
Hopital Notre-Dame du CHUM
Montreal, Quebec, H2L 4M1, Canada
McGill Cancer Centre at McGill University
Montreal, Quebec, H2W 1S6, Canada
Centre Hospitalier Universitaire de Quebec
Québec, Quebec, G1R 2J6, Canada
Related Publications (1)
Brown PD, Pugh S, Laack NN, Wefel JS, Khuntia D, Meyers C, Choucair A, Fox S, Suh JH, Roberge D, Kavadi V, Bentzen SM, Mehta MP, Watkins-Bruner D; Radiation Therapy Oncology Group (RTOG). Memantine for the prevention of cognitive dysfunction in patients receiving whole-brain radiotherapy: a randomized, double-blind, placebo-controlled trial. Neuro Oncol. 2013 Oct;15(10):1429-37. doi: 10.1093/neuonc/not114. Epub 2013 Aug 16.
PMID: 23956241DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Given the poor compliance of the HVLT-R at 24 weeks, there was only 35% statistical power to detect the hypothesized effect size. Please see linked manuscript.
Results Point of Contact
- Title
- Wendy Seiferheld, M.S.
- Organization
- NRG Oncology
Study Officials
- PRINCIPAL INVESTIGATOR
Paul D. Brown, MD
Mayo Clinic
- STUDY CHAIR
Christina A. Meyers, PhD
M.D. Anderson Cancer Center
- STUDY CHAIR
Sherry Fox, RN, PhD
Bon Secours Cancer Institute at St. Mary's Hospital
- STUDY CHAIR
Deepak Khuntia, MD
University of Wisconsin, Madison
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2007
First Posted
December 4, 2007
Study Start
March 1, 2008
Primary Completion
April 1, 2011
Study Completion
December 1, 2016
Last Updated
August 21, 2017
Results First Posted
July 21, 2017
Record last verified: 2017-07