AzTrials
AzTrials

Cognitive/Functional EffectsPhase 3NCT00566852

Memantine in Preventing Side Effects in Patients Undergoing Whole-Brain Radiation Therapy for Brain Metastases From Solid Tumors

A Phase 3 study testing Memantine and Whole brain radiation therapy in people with Cognitive/Functional Effects and Metastatic Cancer, run by Radiation Therapy Oncology Group at 235 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 120 years
What is being tested?
Memantine and Whole brain radiation therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
554 participants
Where
235 sitesin 2 countries
Study dates
Mar 2008to Dec 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • Fertile patients must practice adequate contraception
  • 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)

Who cannot join

  • 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
Show all 14Show fewer
  • 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:
  • 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
  • Chronic short-acting benzodiazepine use

Trial locations and contacts

235 sites in 2 countries.

235 sites in 2 countries

United States229 sites

  • Rosenfeld Cancer Center at Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • McDowell Cancer Center at Akron General Medical Center

    Akron, Ohio, 44307

  • Summa Center for Cancer Care at Akron City Hospital

    Akron, Ohio, 44309-2090

  • New York Oncology Hematology, PC at Albany Regional Cancer Care

    Albany, New York, 12206

  • Veterans Affairs Medical Center - Albany

    Albany, New York, 12208

  • Albert Lea Cancer Center at Albert Lea Medical Center

    Albert Lea, Minnesota, 56007

  • Lovelace Medical Center - Downtown

    Albuquerque, New Mexico, 87102

  • Radiation Oncology Associates, PA

    Albuquerque, New Mexico, 87109

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87131-5636

  • Saint John's Cancer Center at Saint John's Medical Center

    Anderson, Indiana, 46016

  • Theda Care Cancer Institute

    Appleton, Wisconsin, 54911

  • Texas Oncology, PA at Texas Cancer Center - Arlington South

    Arlington, Texas, 76014

  • Northwest Community Hospital

    Arlington Heights, Illinois, 60005

  • Mission Hospitals - Memorial Campus

    Asheville, North Carolina, 28801

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

  • Auburn Radiation Oncology

    Auburn, California, 95603

  • Rocky Mountain Cancer Centers - Aurora

    Aurora, Colorado, 80012

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • St. Agnes Hospital Cancer Center

    Baltimore, Maryland, 21229

  • Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center

    Baltimore, Maryland, 21237

  • Good Samaritan Hospital of Maryland

    Baltimore, Maryland, 21239

  • Barberton Citizens Hospital

    Barberton, Ohio, 44203

  • UPMC Cancer Center at Beaver Medical Center

    Beaver, Pennsylvania, 15009

  • Texas Oncology, PA at Harris Center HEB

    Bedford, Texas, 76022

  • St. Luke's Cancer Network at St. Luke's Hospital

    Bethlehem, Pennsylvania, 18015

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Bloomington Hospital Regional Cancer Institute

    Bloomington, Indiana, 47403

  • Boston University Cancer Research Center

    Boston, Massachusetts, 02118

  • Ocean Medical Center at Meridian Health

    Brick, New Jersey, 08724

  • New York Methodist Hospital

    Brooklyn, New York, 11215

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Providence Saint Joseph Medical Center - Burbank

    Burbank, California, 91505

  • Fletcher Allen Health Care - University Health Center Campus

    Burlington, Vermont, 05401

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Cancer Institute of New Jersey at Cooper University Hospital - Camden

    Camden, New Jersey, 08103

  • Radiation Oncology Centers - Cameron Park

    Cameron Park, California, 95682

  • Sands Cancer Center

    Canandaigua, New York, 14424

  • Mercy Cancer Center at Mercy San Juan Medical Center

    Carmichael, California, 95608

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

  • John H. Stroger, Jr. Hospital of Cook County

    Chicago, Illinois, 60612-3785

  • Enloe Cancer Center at Enloe Medical Center

    Chico, California, 95926

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267

  • UPMC Cancer Center at Jefferson Regional Medical Center

    Clairton, Pennsylvania, 15025

  • Cancer Center at Clarion Hospital

    Clarion, Pennsylvania, 16214

  • Cleveland Clinic Cancer Center at Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Rocky Mountain Cancer Centers - Colorado Springs

    Colorado Springs, Colorado, 80909

  • Central Maryland Oncology Center

    Columbia, Maryland, 21044

  • John B. Amos Cancer Center

    Columbus, Georgia, 31904

  • Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210-1240

  • Charach Cancer Center at Huron Valley - Sinai Hospital

    Commerce, Michigan, 48382

  • Cancer Care Center at John Muir Health - Concord Campus

    Concord, California, 94524-4110

  • Payson Center for Cancer Care at Concord Hospital

    Concord, New Hampshire, 03301

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • Texas Oncology, PA at Texas Cancer Center Dallas Southwest

    Dallas, Texas, 75237

  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

    Dallas, Texas, 75390

  • Geisinger Cancer Institute at Geisinger Health

    Danville, Pennsylvania, 17822-0001

  • Veterans Affairs Medical Center - Atlanta (Decatur)

    Decatur, Georgia, 30033

  • Texas Oncology, PA at Texas Cancer Center - Denton South

    Denton, Texas, 76210

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • Delaware County Regional Cancer Center at Delaware County Memorial Hospital

    Drexel Hill, Pennsylvania, 19026

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

  • Northeast Radiation Oncology Center

    Dunmore, Pennsylvania, 18512

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Trinitas Comprehensive Cancer Center at Trinitas Hospital

    Elizabeth, New Jersey, 07207

  • Willamette Valley Cancer Center - Eugene

    Eugene, Oregon, 97401

  • Great Lakes Cancer Institute at McLaren Regional Medical Center

    Flint, Michigan, 48532

  • Poudre Valley Radiation Oncology

    Fort Collins, Colorado, 80528

  • Radiation Oncology Associates Southwest

    Fort Wayne, Indiana, 46804

  • Parkview Regional Cancer Center at Parkview Health

    Fort Wayne, Indiana, 46805

  • Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital

    Fort Worth, Texas, 76104

  • Mercy and Unity Cancer Center at Unity Hospital

    Fridley, Minnesota, 55432

  • University of Florida Shands Cancer Center

    Gainesville, Florida, 32610-0232

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Adams Cancer Center

    Gettysburg, Pennsylvania, 17325

  • Tate Cancer Center at Baltimore Washington Medical Center

    Glen Burnie, Maryland, 21061

  • Glendale Adventist Medical Center

    Glendale, California, 91206

  • Center for Cancer Care at Goshen General Hospital

    Goshen, Indiana, 46526

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • Three Rivers Community Hospital

    Grants Pass, Oregon, 97527

  • St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54307-3508

  • UPMC Cancer Center - Arnold Palmer Pavilion

    Greensburg, Pennsylvania, 15601

  • Cherry Tree Cancer Center

    Hanover, Pennsylvania, 17331

  • Penn State Cancer Institute at Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Cleveland Clinic Cancer Center

    Independence, Ohio, 44131

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202-5289

  • Methodist Cancer Center at Methodist Hospital

    Indianapolis, Indiana, 46202

  • Central Indiana Cancer Centers - East

    Indianapolis, Indiana, 46219

  • Community Regional Cancer Care at Community Hospital East

    Indianapolis, Indiana, 46219

  • Community Regional Cancer Care at Community Hospital North

    Indianapolis, Indiana, 46256

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242-1002

  • Baptist Cancer Institute - Jacksonville

    Jacksonville, Florida, 32207

  • Integrated Community Oncology Network at Southside Cancer Center

    Jacksonville, Florida, 32207

  • Baptist Medical Center South

    Jacksonville, Florida, 32258

  • Integrated Community Oncology Network

    Jacksonville Beach, Florida, 32250

  • Princeton Radiation Oncology Center

    Jamesburg, New Jersey, 08831

  • UPMC Cancer Center at the John P. Murtha Pavilion

    Johnstown, Pennsylvania, 15901

  • Kansas City Cancer Centers - South

    Kansas City, Missouri, 64131

  • Kansas City Cancer Centers - North

    Kansas City, Missouri, 64154

  • Franciscan Skemp Healthcare - La Crosse Campus

    La Crosse, Wisconsin, 54601

  • Rebecca and John Moores UCSD Cancer Center

    La Jolla, California, 92093-0658

  • CCOP - Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Lucille P. Markey Cancer Center at University of Kentucky

    Lexington, Kentucky, 40536-0093

  • St. Mary Mercy Hospital

    Livonia, Michigan, 48154

  • Longview Cancer Center

    Longview, Texas, 75601

  • Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90089-9181

  • Norton Suburban Hospital

    Louisville, Kentucky, 40207

  • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

    Madison, Wisconsin, 53792-6164

  • Elliot Regional Cancer Center at Elliot Hospital

    Manchester, New Hampshire, 03103

  • CCOP - North Shore University Hospital

    Manhasset, New York, 11030

  • Immanuel St. Joseph's

    Mankato, Minnesota, 56002

  • Minnesota Oncology Hematology, PA - Maplewood

    Maplewood, Minnesota, 55109

  • Bay Area Cancer Care Center at Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • Northwest Ohio Oncology Center

    Maumee, Ohio, 43537-1839

  • Hillcrest Cancer Center at Hillcrest Hospital

    Mayfield Heights, Ohio, 44124

  • UPMC Cancer Center at UPMC McKeesport

    McKeesport, Pennsylvania, 15132

  • Dubs Cancer Center at Rogue Valley Medical Center

    Medford, Oregon, 97504

  • Providence Cancer Center at PMCC

    Medford, Oregon, 97504

  • Community Memorial Hospital Cancer Care Center

    Menomonee Falls, Wisconsin, 53051

  • Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Medical College of Wisconsin Cancer Center

    Milwaukee, Wisconsin, 53226

  • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Trinity CancerCare Center

    Minot, North Dakota, 58701

  • MBCCOP - Gulf Coast

    Mobile, Alabama, 36604

  • Providence Cancer Center at Providence Hospital

    Mobile, Alabama, 36608

  • UPMC - Moon

    Moon Township, Pennsylvania, 15108

  • Cancer Center at Ball Memorial Hospital

    Muncie, Indiana, 47303-3499

  • Jon and Karen Huntsman Cancer Center at Intermountain Medical Center

    Murray, Utah, 84157

  • UPMC Cancer Center - Natrona Heights

    Natrona Heights, Pennsylvania, 15065

  • Saint Peter's University Hospital

    New Brunswick, New Jersey, 08901

  • Jameson Memorial Hospital - North Campus

    New Castle, Pennsylvania, 16105

  • Yale Cancer Center

    New Haven, Connecticut, 06520-8028

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11040

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • Sentara Cancer Institute at Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • West Texas Cancer Center

    Odessa, Texas, 79761

  • Val and Ann Browning Cancer Center at McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • Oklahoma University Cancer Institute

    Oklahoma City, Oklahoma, 73104

  • Methodist Estabrook Cancer Center

    Omaha, Nebraska, 68114

  • Nebraska Medical Center

    Omaha, Nebraska, 68198

  • St. Joseph Hospital Regional Cancer Center - Orange

    Orange, California, 92868

  • Integrated Community Oncology Network - Orange Park

    Orange Park, Florida, 32073

  • St. Charles Mercy Hospital

    Oregon, Ohio, 43616

  • Florida Institute of Research, Medicine and Surgery Cancer Center

    Orlando, Florida, 32806

  • Kansas City Cancer Centers - Southwest

    Overland Park, Kansas, 66210

  • Florida Cancer Center - Palatka

    Palatka, Florida, 32177

  • Regional Cancer Center at Singing River Hospital

    Pascagoula, Mississippi, 39581

  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107-5541

  • Fox Chase Cancer Center - Philadelphia

    Philadelphia, Pennsylvania, 19111-2497

  • Albert Einstein Cancer Center

    Philadelphia, Pennsylvania, 19141

  • Arizona Oncology Services Foundation

    Phoenix, Arizona, 85013

  • UPMC - Shadyside

    Pittsburgh, Pennsylvania, 15213-2582

  • UPMC Cancer Center at Magee-Womens Hospital

    Pittsburgh, Pennsylvania, 15213

  • UPMC Cancer Center at UPMC St. Margaret

    Pittsburgh, Pennsylvania, 15215

  • UPMC Cancer Center at UPMC Passavant

    Pittsburgh, Pennsylvania, 15237

  • UPMC Cancer Center - Upper St. Clair

    Pittsburgh, Pennsylvania, 15243

  • University Medical Center at Princeton

    Princeton, New Jersey, 08540-3298

  • All Saints Cancer Center at Wheaton Franciscan Healthcare

    Racine, Wisconsin, 53405

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

  • Renown Institute for Cancer at Renown Regional Medical Center

    Reno, Nevada, 89502

  • Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center

    Robbinsdale, Minnesota, 55422-2900

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Highland Hospital of Rochester

    Rochester, New York, 14620

  • Lipson Cancer and Blood Center at Rochester General Hospital

    Rochester, New York, 14621

  • University Radiation Oncology at Parkridge Hospital

    Rochester, New York, 14626

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, 14642

  • Radiation Oncology Center - Roseville

    Roseville, California, 95661

  • William Beaumont Hospital - Royal Oak Campus

    Royal Oak, Michigan, 48073

  • Radiological Associates of Sacramento Medical Group, Incorporated

    Sacramento, California, 95815

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • Mercy General Hospital

    Sacramento, California, 95819

  • Flagler Cancer Center

    Saint Augustine, Florida, 32086

  • CentraCare Clinic - River Campus

    Saint Cloud, Minnesota, 56303

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Cancer Care Center, Incorporated

    Salem, Ohio, 44460

  • Utah Cancer Specialists at UCS Cancer Center

    Salt Lake City, Utah, 84106

  • Huntsman Cancer Institute at University of Utah

    Salt Lake City, Utah, 84112

  • Cancer Care Centers of South Texas - Northeast

    San Antonio, Texas, 78217

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229-3900

  • North Coast Cancer Care, Incorporated

    Sandusky, Ohio, 44870

  • Mayo Clinic Scottsdale

    Scottsdale, Arizona, 85259-5499

  • CCOP - Virginia Mason Research Center

    Seattle, Washington, 98101

  • UPMC Cancer Center at UPMC Northwest

    Seneca, Pennsylvania, 16346

  • Texas Oncology, PA at Texas Cancer Center - Sherman

    Sherman, Texas, 75090

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • Cancer Care Northwest - Spokane South

    Spokane, Washington, 99202

  • Cancer Institute at St. John's Hospital

    Springfield, Illinois, 62702

  • Hulston Cancer Center at Cox Medical Center South

    Springfield, Missouri, 65807

  • CCOP - St. Louis-Cape Girardeau

    St Louis, Missouri, 63141

  • Dixie Regional Medical Center - East Campus

    St. George, Utah, 84770

  • Stanford Cancer Center

    Stanford, California, 94305-5824

  • Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land

    Sugar Land, Texas, 77479

  • Flower Hospital Cancer Center

    Sylvania, Ohio, 43560

  • Medical University of Ohio Cancer Center

    Toledo, Ohio, 43614

  • CCOP - Toledo Community Hospital

    Toledo, Ohio, 43617

  • St. Anne Mercy Hospital

    Toledo, Ohio, 43623

  • J. Phillip Citta Regional Cancer Center at Community Medical Center

    Toms River, New Jersey, 08755

  • Cancer Institute at St. Joseph Medical Center

    Towson, Maryland, 21204

  • Arizona Oncology - Tucson

    Tucson, Arizona, 85704

  • Arizona Cancer Center at University of Arizona Health Sciences Center

    Tucson, Arizona, 85724-5024

  • Emanuel Regional Cancer Services at Emanuel Medical Center

    Turlock, California, 95382

  • Tyler Cancer Center

    Tyler, Texas, 75702

  • UPMC Cancer Center - Uniontown

    Uniontown, Pennsylvania, 15401

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • Solano Radiation Oncology Center

    Vacaville, California, 95687

  • Cancer Institute of New Jersey at Cooper - Voorhees

    Voorhees Township, New Jersey, 08043

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • John Muir/Mt. Diablo Comprehensive Cancer Center

    Walnut Creek, California, 94598

  • Washington Hospital Cancer Center

    Washington, Pennsylvania, 15301

  • Washington Cancer Institute at Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • University of Wisconcin Cancer Center at Aspirus Wausau Hospital

    Wausau, Wisconsin, 54401

  • West Allis Memorial Hospital

    West Allis, Wisconsin, 53227

  • Precision Radiotherapy at University Pointe

    West Chester, Ohio, 45069

  • Schiffler Cancer Center at Wheeling Hospital

    Wheeling, West Virginia, 26003

  • New Hanover Radiation Oncology, PA

    Wilmington, North Carolina, 28401

  • Cancer Treatment Center

    Wooster, Ohio, 44691

  • Cleveland Clinic - Wooster

    Wooster, Ohio, 44691

  • Lankenau Cancer Center at Lankenau Hospital

    Wynnewood, Pennsylvania, 19096

  • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital

    Yakima, Washington, 98902

  • York Cancer Center at Apple Hill Medical Center

    York, Pennsylvania, 17405

Other trials in United States

Canada6 sites

  • Nova Scotia Cancer Centre

    Halifax, Nova Scotia, B3H 1V8

  • London Regional Cancer Program at London Health Sciences Centre

    London, Ontario, N6A 4L6

  • Maisonneuve-Rosemont Hospital

    Montreal, Quebec, H1T 2M4

  • Hopital Notre-Dame du CHUM

    Montreal, Quebec, H2L 4M1

  • McGill Cancer Centre at McGill University

    Montreal, Quebec, H2W 1S6

  • Centre Hospitalier Universitaire de Quebec

    Québec, Quebec, G1R 2J6

Other trials in Canada

About this study

Official title: A Randomized, Phase III, Double-Blind, Placebo-Controlled Trial of Memantine for Prevention of Cognitive Dysfunction in Patients Receiving Whole-Brain Radiotherapy

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.

Read the detailed description

OBJECTIVES:

Primary

  • Determine whether the addition of memantine hydrochloride to whole-brain radiotherapy (WBRT) preserves cognitive function, specifically memory, as measured by the Hopkins Verbal Learning Test for delayed recall (HVLT-delayed recall), over that of placebo and WBRT in patients with brain metastases at 24 weeks from the start of drug treatment.

Secondary

  • Determine whether the addition of memantine hydrochloride preserves cognitive function, specifically memory, as measured by the HVLT-delayed recall at 8 weeks, 16 weeks, and 12 months from the start of drug treatment.
  • Determine whether the addition of memantine hydrochloride increases time to neurocognitive failure as measured by cognitive decline on a battery of tests including the HVLT for free recall, delayed recall, and delayed recognition; the Controlled Word Association Test (COWAT); the Trail Making Test Parts A and B (TMT); the Medical Outcomes Scale-Cognitive Functioning Subscale (MOS); and the Mini-Mental Status Examination (MMSE).
  • Evaluate the potential benefit of memantine hydrochloride in change and overall quality of life, as measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br) subscale.
  • Determine whether the addition of memantine hydrochloride increases progression-free survival.
  • Determine whether the addition of memantine hydrochloride increases overall survival.
  • Compare adverse events between the treatment arms according to the CTCAE v3.0 criteria.
  • Collect serum, plasma, buffy coat cells, urine, and cerebrospinal fluid (CSF) for future translational research analyses.

OUTLINE: This is a multicenter study. Patients are stratified according to recursive partitioning analysis (RPA) prognostic class (class I vs class II with controlled systemic disease) and prior surgical therapy (none vs radiosurgery or surgical resection). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo whole-brain radiotherapy (WBRT) 5 days a week for 3 weeks (15 fractions). Patients also receive oral memantine hydrochloride once daily beginning on day 1 of WBRT and continuing for 24 weeks.
  • Arm II: Patients undergo WBRT as in arm I. Patients also receive oral placebo once daily beginning on day 1 of WBRT and continuing for 24 weeks.

After completion of study treatment, patients are followed at 6 months, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Being tested
Memantine, Placebo, Whole brain radiation therapy
Keywords
cognitive/functional effects, neurotoxicity, tumors metastatic to brain, unspecified adult solid tumor, protocol specific
Medical subject headings
Neoplasm Metastasis, Neurotoxicity Syndromes, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MemantineDrug

    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.

  • PlaceboOther

    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 therapyRadiation

    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

Study groups in NCT00566852
Study groupRoleWhat they receive
WBRT+MemantineExperimentalWhole brain radiation therapy (WBRT) and memantine
Receives: Drug: Memantine; Radiation: Whole brain radiation therapy
WBRT+PlaceboActive comparatorWhole brain radiation therapy (WBRT) and placebo
Receives: Other: Placebo; Radiation: Whole brain radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and 24 weeks from the start of drug treatment

Secondary outcomes (5)

  1. Change in the Hopkins Verbal Learning Test - Revised for Delayed Recall (HVLT-R-delayed Recall) at 8, 16, and 52 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 the respective later time point value. Imputation methods were used to determine values for all alive patients missing the post-baseline assessments. This tool is being used to measure cognitive function, specifically memory.

    Measured: Baseline, 8, 16, and 52 weeks from the start of drug treatment

  2. Median Time to Neurocognitive Failure

    Neurocognitive failure is defined as the first cognitive failure on any of the neurocognitive tests: the HVLT-R for immediate recall, delayed recognition, and delayed recall; the Controlled Oral Word Association Test (COWAT); the Trail-Making Test (TMT) Parts A and B. Cognitive failure for each test is defined as a post-treatment score that meets one of the following criteria: follow-up score is at least 2 standard deviations worse than the patient's personal baseline score or the patient's raw score change is greater than the reliable change index. The cumulative incidence approach was used to estimate the median time to neurocognitive failure to account for the competing risks of disease progression and death.

    Measured: Baseline to 12 months from the start of drug treatment

  3. Change in Functional Assessment of Cancer Therapy With Brain Subscale (FACT-Br) at 24 Weeks

    The FACT-Br is a 50-question self-report questionnaire contains the following domains (scales): Physical well-being (7 questions), social/family well-being (7 questions), emotional well-being (6 questions), functional well-being (7 questions) and brain cancer subscale which contains concerns relevant to patients with brain tumors (23 questions). Each question has a value 0-4. For some questions a higher indicates better outcome and others are the opposite. The former are summed as is, the latter are reversed in value before adding, such that each domain ranges from 0 to 4 times the number of questions in the domain, with 0 indicating worst and the highest possible value indicating best outcome. The FACT-Br total is obtained by adding all domains together if the overall question response rate is greater than 80%. Total scores on the FACT-Br range from 0 to 184 with lower scores indicating declining quality of life. Change is calculated as baseline score subtracted from 24-week score.

    Measured: Baseline and 24 weeks from start of treatment

  4. Median Progression-free Survival Time

    Disease progression is defined as the first of the following events: an increase of at least 50% for lesions less than or equal to 1cm, an increase of least 25% for lesions greater than 1cm, appearance of any new brain metastases. Failure for progression-free survival is disease progression or death. Median progression-free survival was estimated using the Kaplan-Meier method.

    Measured: 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.

  5. Overall Survival

    Failure for overall survival is death from any cause. Median survival was estimated using the Kaplan-Meier method.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2007 (estimated)
  2. Study startMar 2008
  3. Primary completionApr 2011
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
554 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00566852
Sponsor's protocol ID
RTOG-0614
Other IDs
CDR0000577872, NCI-2009-00735
Status last verified
Jul 2017
First submitted
1 Dec 2007
Last updated
21 Aug 2017
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23956241

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Memantine and Whole brain radiation therapy in people with Cognitive/Functional Effects and Metastatic Cancer, run by Radiation Therapy Oncology Group at 235 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 235 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Hopkins Verbal Learning Test - Revised for Delayed Recall (HVLT-R-delayed Recall) at 24 Weeks (time frame: Baseline and 24 weeks from the start of drug treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00566852, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2017.

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