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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00566852
First received: December 1, 2007
Last updated: December 20, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Cognitive/Functional Effects
Metastatic Cancer
Neurotoxicity
Unspecified Adult Solid Tumor, Protocol Specific
Drug: memantine hydrochloride
Other: placebo
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: A Randomized, Phase III, Double-Blind, Placebo-Controlled Trial of Memantine for Prevention of Cognitive Dysfunction in Patients Receiving Whole-Brain Radiotherapy

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Cognitive function, specifically memory, 24 weeks from the start of drug treatment as measured by the Hopkins Verbal Learning Test-Revised for delayed recall (HVLT-R-delayed recall) [ Time Frame: Baseline to 24 weeks from the start of drug treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cognitive function, specifically memory, 8 weeks, 16 weeks, and 12 months from the start of treatment as measured by the HVLT-R-delayed recall [ Time Frame: Baseline to 12 months from the start of drug treatment ] [ Designated as safety issue: No ]
  • Neurocognitive failure as measured by a battery of tests [ Time Frame: Baseline to 12 months from the start of drug treatment ] [ Designated as safety issue: No ]
  • Quality-of-life as measured by the Functional Assessment of Cancer Therapy Brain subscale (FACT-Br) [ Time Frame: Baseline to 12 months from the start of drug treatment ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: From randomization to date of progression, death or last follow-up. Analysis occurs at the same time as the primary outcome. ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: From randomization to date of death or last follow-up. Analysis occurs at the same time as the primary outcome. ] [ Designated as safety issue: No ]

Enrollment: 554
Study Start Date: March 2008
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: memantine hydrochloride
Given orally
Radiation: radiation therapy
Patients undergo whole-brain radiotherapy (WBRT) 5 days a week for 3 weeks.
Active Comparator: 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.
Other: placebo
Given orally
Radiation: radiation therapy
Patients undergo whole-brain radiotherapy (WBRT) 5 days a week for 3 weeks.

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed diagnosis of a solid tumor malignancy within the past 5 years

    • If the original histologic proof of malignancy is > 5 years, then pathological (i.e., more recent) confirmation is required (e.g., from a systemic metastasis or brain metastasis)
  • Brain metastases must be visible on contrast-enhanced MRI or a contrast enhanced CT scan (for patients unable to undergo MRI within the past 28 days)

    • Patients unable to undergo MRI imaging because of non-compatible devices are eligible, provided the contrast-enhanced CT scans are obtained and are of sufficient quality
    • Patients who had undergone radiosurgery or surgical resection and are planning adjuvant whole-brain radiotherapy do not have to have visible disease but do need a baseline MRI
  • Must have stable systemic disease (i.e. no evidence of systemic disease progression within the past 3 months)
  • Patients with brain metastases at initial presentation are eligible and do not need to demonstrate 3 months of stable scans

PATIENT CHARACTERISTICS:

Inclusion

  • Karnofsky performance status 70-100%
  • Serum creatinine ≤ 3 mg/dL and creatinine clearance ≥ 30 mL/min
  • Total bilirubin ≤ 2.5 mg/dL
  • BUN < 20 mg/dL
  • Mini-mental status exam score ≥ 18
  • Negative serum pregnancy test
  • Fertile patients must practice adequate contraception

Exclusion

  • 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:

Inclusion

  • 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)

Exclusion

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00566852

  Hide Study Locations
Locations
United States, Alabama
MBCCOP - Gulf Coast
Mobile, Alabama, United States, 36604
Providence Cancer Center at Providence Hospital
Mobile, Alabama, United States, 36608
United States, Arizona
Arizona Oncology Services Foundation
Phoenix, Arizona, United States, 85013
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724-5024
Arizona Oncology - Tucson
Tucson, Arizona, United States, 85704
United States, California
Auburn Radiation Oncology
Auburn, California, United States, 95603
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States, 91505
Radiation Oncology Centers - Cameron Park
Cameron Park, California, United States, 95682
Mercy Cancer Center at Mercy San Juan Medical Center
Carmichael, California, United States, 95608
Enloe Cancer Center at Enloe Medical Center
Chico, California, United States, 95926
Cancer Care Center at John Muir Health - Concord Campus
Concord, California, United States, 94524-4110
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Glendale Adventist Medical Center
Glendale, California, United States, 91206
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0658
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
St. Joseph Hospital Regional Cancer Center - Orange
Orange, California, United States, 92868
Radiation Oncology Center - Roseville
Roseville, California, United States, 95661
Radiological Associates of Sacramento Medical Group, Incorporated
Sacramento, California, United States, 95815
Mercy General Hospital
Sacramento, California, United States, 95819
University of California Davis Cancer Center
Sacramento, California, United States, 95817
Stanford Cancer Center
Stanford, California, United States, 94305-5824
Emanuel Regional Cancer Services at Emanuel Medical Center
Turlock, California, United States, 95382
Solano Radiation Oncology Center
Vacaville, California, United States, 95687
John Muir/Mt. Diablo Comprehensive Cancer Center
Walnut Creek, California, United States, 94598
United States, Colorado
Rocky Mountain Cancer Centers - Aurora
Aurora, Colorado, United States, 80012
Rocky Mountain Cancer Centers - Colorado Springs
Colorado Springs, Colorado, United States, 80909
Poudre Valley Radiation Oncology
Fort Collins, Colorado, United States, 80528
United States, Connecticut
Yale Cancer Center
New Haven, Connecticut, United States, 06520-8028
United States, Delaware
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, District of Columbia
Washington Cancer Institute at Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610-0232
Integrated Community Oncology Network at Southside Cancer Center
Jacksonville, Florida, United States, 32207
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, United States, 32207
Integrated Community Oncology Network
Jacksonville Beach, Florida, United States, 32250
Baptist Medical Center South
Jascksonville, Florida, United States, 32258
Integrated Community Oncology Network - Orange Park
Orange Park, Florida, United States, 32073
Florida Institute of Research, Medicine and Surgery Cancer Center
Orlando, Florida, United States, 32806
Florida Cancer Center - Palatka
Palatka, Florida, United States, 32177
Flagler Cancer Center
Saint Augustine, Florida, United States, 32086
United States, Georgia
Winship Cancer Institute of Emory University
Altanta, Georgia, United States, 30322
John B. Amos Cancer Center
Columbus, Georgia, United States, 31904
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, United States, 30033
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
United States, Illinois
Northwest Community Hospital
Arlington Heights, Illinois, United States, 60005
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, United States, 60612-3785
Cancer Institute at St. John's Hospital
Springfield, Illinois, United States, 62702
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
Saint John's Cancer Center at Saint John's Medical Center
Anderson, Indiana, United States, 46016
Bloomington Hospital Regional Cancer Institute
Bloomington, Indiana, United States, 47403
Parkview Regional Cancer Center at Parkview Health
Fort Wayne, Indiana, United States, 46805
Radiation Oncology Associates Southwest
Fort Wayne, Indiana, United States, 46804
Center for Cancer Care at Goshen General Hospital
Goshen, Indiana, United States, 46526
Community Regional Cancer Care at Community Hospital East
Indianapolis, Indiana, United States, 46219
Methodist Cancer Center at Methodist Hospital
Indianapolis, Indiana, United States, 46202
Central Indiana Cancer Centers - East
Indianapolis, Indiana, United States, 46219
Community Regional Cancer Care at Community Hospital North
Indianapolis, Indiana, United States, 46256
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202-5289
Cancer Center at Ball Memorial Hospital
Muncie, Indiana, United States, 47303-3499
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1002
United States, Kansas
Kansas City Cancer Centers - Southwest
Overland Park, Kansas, United States, 66210
United States, Kentucky
Lucille P. Markey Cancer Center at University of Kentucky
Lexington, Kentucky, United States, 40536-0093
Norton Suburban Hospital
Louisville, Kentucky, United States, 40207
United States, Maryland
Good Samaritan Hospital of Maryland
Baltimore, Maryland, United States, 21239
St. Agnes Hospital Cancer Center
Baltimore, Maryland, United States, 21229
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
Baltimore, Maryland, United States, 21237
Central Maryland Oncology Center
Columbia, Maryland, United States, 21044
Tate Cancer Center at Baltimore Washington Medical Center
Glen Burnie, Maryland, United States, 21061
Cancer Institute at St. Joseph Medical Center
Towson, Maryland, United States, 21204
United States, Massachusetts
Boston University Cancer Research Center
Boston, Massachusetts, United States, 02118
United States, Michigan
Charach Cancer Center at Huron Valley - Sinai Hospital
Commerce, Michigan, United States, 48382
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
Great Lakes Cancer Institute at McLaren Regional Medical Center
Flint, Michigan, United States, 48532
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
St. Mary Mercy Hospital
Livonia, Michigan, United States, 48154
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Albert Lea Cancer Center at Albert Lea Medical Center
Albert Lea, Minnesota, United States, 56007
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
Immanuel St. Joseph's
Mankato, Minnesota, United States, 56002
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota, United States, 55109
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States, 55422-2900
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
CentraCare Clinic - River Campus
Saint Cloud, Minnesota, United States, 56303
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
United Hospital
Saint Paul, Minnesota, United States, 55102
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
United States, Mississippi
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, United States, 39581
United States, Missouri
Kansas City Cancer Centers - South
Kansas City, Missouri, United States, 64131
Kansas City Cancer Centers - North
Kansas City, Missouri, United States, 64154
CCOP - St. Louis-Cape Girardeau
Saint Louis, Missouri, United States, 63141
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States, 65807
United States, Montana
Billings Clinic - Downtown
Billings, Montana, United States, 59107-7000
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
United States, Nebraska
Methodist Estabrook Cancer Center
Omaha, Nebraska, United States, 68114
Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, Nevada
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
Renown Institute for Cancer at Renown Regional Medical Center
Reno, Nevada, United States, 89502
United States, New Hampshire
Payson Center for Cancer Care at Concord Hospital
Concord, New Hampshire, United States, 03301
Elliot Regional Cancer Center at Elliot Hospital
Manchester, New Hampshire, United States, 03103
United States, New Jersey
Ocean Medical Center at Meridian Health
Brick, New Jersey, United States, 08724
Cancer Institute of New Jersey at Cooper University Hospital - Camden
Camden, New Jersey, United States, 08103
Trinitas Comprehensive Cancer Center at Trinitas Hospital
Elizabeth, New Jersey, United States, 07207
Princeton Radiation Oncology Center
Jamesburg, New Jersey, United States, 08831
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08901
University Medical Center at Princeton
Princeton, New Jersey, United States, 08540-3298
J. Phillip Citta Regional Cancer Center at Community Medical Center
Toms River, New Jersey, United States, 08755
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees, New Jersey, United States, 08043
United States, New Mexico
Lovelace Medical Center - Downtown
Albuquerque, New Mexico, United States, 87102
Radiation Oncology Associates, PA
Albuquerque, New Mexico, United States, 87109
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131-5636
United States, New York
Veterans Affairs Medical Center - Albany
Albany, New York, United States, 12208
New York Oncology Hematology, PC at Albany Regional Cancer Care
Albany, New York, United States, 12206
New York Methodist Hospital
Brooklyn, New York, United States, 11215
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sands Cancer Center
Canandiaqua, New York, United States, 14424
CCOP - North Shore University Hospital
Manhasset, New York, United States, 11030
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
Highland Hospital of Rochester
Rochester, New York, United States, 14620
Lipson Cancer and Blood Center at Rochester General Hospital
Rochester, New York, United States, 14621
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
University Radiation Oncology at Parkridge Hospital
Rochester, New York, United States, 14626
United States, North Carolina
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States, 28801
New Hanover Radiation Oncology, PA
Wilmington, North Carolina, United States, 28401
United States, North Dakota
Trinity CancerCare Center
Minot, North Dakota, United States, 58701
United States, Ohio
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, United States, 44309-2090
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States, 44307
Barberton Citizens Hospital
Barberton, Ohio, United States, 44203
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45267
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland, Ohio, United States, 44111
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210-1240
Cleveland Clinic Cancer Center
Independence, Ohio, United States, 44131
Northwest Ohio Oncology Center
Maumee, Ohio, United States, 43537-1839
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, United States, 44124
St. Charles Mercy Hospital
Oregon, Ohio, United States, 43616
Cancer Care Center, Incorporated
Salem, Ohio, United States, 44460
North Coast Cancer Care, Incorporated
Sandusky, Ohio, United States, 44870
Flower Hospital Cancer Center
Sylvania, Ohio, United States, 43560
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43617
St. Anne Mercy Hospital
Toledo, Ohio, United States, 43623
Medical University of Ohio Cancer Center
Toledo, Ohio, United States, 43614
Precision Radiotherapy at University Pointe
West Chester, Ohio, United States, 45069
Cancer Treatment Center
Wooster, Ohio, United States, 44691
Cleveland Clinic - Wooster
Wooster, Ohio, United States, 44691
United States, Oklahoma
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Willamette Valley Cancer Center - Eugene
Eugene, Oregon, United States, 97401
Three Rivers Community Hospital
Grants Pass, Oregon, United States, 97527
Dubs Cancer Center at Rogue Valley Medical Center
Medford, Oregon, United States, 97504
Providence Cancer Center at PMCC
Medford, Oregon, United States, 97504
United States, Pennsylvania
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
UPMC Cancer Center at Beaver Medical Center
Beaver, Pennsylvania, United States, 15009
St. Luke's Cancer Network at St. Luke's Hospital
Bethlehem, Pennsylvania, United States, 18015
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
UPMC Cancer Center at Jefferson Regional Medical Center
Clairton, Pennsylvania, United States, 15025
Cancer Center at Clarion Hospital
Clarion, Pennsylvania, United States, 16214
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, United States, 17822-0001
Delaware County Regional Cancer Center at Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States, 19026
Northeast Radiation Oncology Center
Dunmore, Pennsylvania, United States, 18512
Adams Cancer Center
Gettysburg, Pennsylvania, United States, 17325
UPMC Cancer Center - Arnold Palmer Pavilion
Greensburg, Pennsylvania, United States, 15601
Cherry Tree Cancer Center
Hanover, Pennsylvania, United States, 17331
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
UPMC Cancer Center at the John P. Murtha Pavilion
Johnstown, Pennsylvania, United States, 15901
UPMC Cancer Center at UPMC McKeesport
McKeesport, Pennsylvania, United States, 15132
UPMC - Moon
Moon Township, Pennsylvania, United States, 15108
UPMC Cancer Center - Natrona Heights
Natrona Heights, Pennsylvania, United States, 15065
Jameson Memorial Hospital - North Campus
New Castle, Pennsylvania, United States, 16105
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States, 19141
UPMC Cancer Center at UPMC Passavant
Pittsburgh, Pennsylvania, United States, 15237
UPMC - Shadyside
Pittsburgh, Pennsylvania, United States, 15213-2582
UPMC Cancer Center at Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
UPMC Cancer Center - Upper St. Clair
Pittsburgh, Pennsylvania, United States, 15243
UPMC Cancer Center at UPMC St. Margaret
Pittsburgh, Pennsylvania, United States, 15215
UPMC Cancer Center at UPMC Northwest
Seneca, Pennsylvania, United States, 16346
UPMC Cancer Center - Uniontown
Uniontown, Pennsylvania, United States, 15401
Washington Hospital Cancer Center
Washington, Pennsylvania, United States, 15301
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
York Cancer Center at Apple Hill Medical Center
York, Pennsylvania, United States, 17405
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
United States, Texas
Texas Oncology, PA at Texas Cancer Center - Arlington South
Arlington, Texas, United States, 76014
Texas Oncology, PA at Harris Center HEB
Bedford, Texas, United States, 76022
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Texas Oncology, PA at Texas Cancer Center Dallas Southwest
Dallas, Texas, United States, 75237
Texas Oncology, PA at Texas Cancer Center - Denton South
Denton, Texas, United States, 76210
Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital
Fort Worth, Texas, United States, 76104
Longview Cancer Center
Longview, Texas, United States, 75601
West Texas Cancer Center
Odessa, Texas, United States, 79761
Cancer Care Centers of South Texas - Northeast
San Antonio, Texas, United States, 78217
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229-3900
Texas Oncology, PA at Texas Cancer Center - Sherman
Sherman, Texas, United States, 75090
Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land
Sugar Land, Texas, United States, 77479
Tyler Cancer Center
Tyler, Texas, United States, 75702
United States, Utah
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Murray, Utah, United States, 84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Dixie Regional Medical Center - East Campus
Saint George, Utah, United States, 84770
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, United States, 84106
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States, 84112
United States, Vermont
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States, 05401
United States, Virginia
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Sentara Cancer Institute at Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
United States, Washington
CCOP - Virginia Mason Research Center
Seattle, Washington, United States, 98101
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, United States, 98902
United States, West Virginia
Schiffler Cancer Center at Wheeling Hospital
Wheeling, West Virginia, United States, 26003
United States, Wisconsin
Theda Care Cancer Institute
Appleton, Wisconsin, United States, 54911
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
Franciscan Skemp Healthcare - La Crosse Campus
La Crosse, Wisconsin, United States, 54601
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Community Memorial Hospital Cancer Care Center
Menomonee Falls, Wisconsin, United States, 53051
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
All Saints Cancer Center at Wheaton Franciscan Healthcare
Racine, Wisconsin, United States, 53405
University of Wisconcin Cancer Center at Aspirus Wausau Hospital
Wausau, Wisconsin, United States, 54401
West Allis Memorial Hospital
West Allis, Wisconsin, United States, 53227
Canada, Nova Scotia
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V8
Canada, Ontario
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
Canada, Quebec
Hopital Notre-Dame du CHUM
Montreal, Quebec, Canada, H2L 4M1
McGill Cancer Centre at McGill University
Montreal, Quebec, Canada, H2W 1S6
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada, H1T 2M4
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, Canada, G1R 2J6
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00566852     History of Changes
Other Study ID Numbers: RTOG-0614, CDR0000577872, NCI-2009-00735
Study First Received: December 1, 2007
Last Updated: December 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Radiation Therapy Oncology Group:
cognitive/functional effects
neurotoxicity
tumors metastatic to brain
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Neurotoxicity Syndromes
Neoplastic Processes
Pathologic Processes
Nervous System Diseases
Poisoning
Chemically-Induced Disorders
Memantine
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents

ClinicalTrials.gov processed this record on August 28, 2014