Clinical trial NCT00566852: Memantine in Preventing Side Effects in Patients Undergoing Whole-Brain Radiation Therapy for Brain Metastases From Solid Tumors
Official title: A Randomized, Phase III, Double-Blind, Placebo-Controlled Trial of Memantine for Prevention of Cognitive Dysfunction in Patients Receiving Whole-Brain Radiotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cognitive/Functional Effects
Metastatic Cancer
Neurotoxicity
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: cognitive/functional effects
neurotoxicity
tumors metastatic to brain
unspecified adult solid tumor, protocol specific
Lead sponsor: Radiation Therapy Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
name: NRG Oncology
First posted: 2007-12-04
Enrollment: 554
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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
* Blood urea nitrogen (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

Primary outcomes:
measure: Change in the Hopkins Verbal Learning Test - Revised for Delayed Recall (HVLT-R-delayed Recall) at 24 Weeks
timeFrame: Baseline and 24 weeks from the start of drug treatment
Secondary outcomes:
measure: Change in the Hopkins Verbal Learning Test - Revised for Delayed Recall (HVLT-R-delayed Recall) at 8, 16, and 52 Weeks
timeFrame: Baseline, 8, 16, and 52 weeks from the start of drug treatment
measure: Median Time to Neurocognitive Failure
timeFrame: Baseline to 12 months from the start of drug treatment
measure: Change in Functional Assessment of Cancer Therapy With Brain Subscale (FACT-Br) at 24 Weeks
timeFrame: Baseline and 24 weeks from start of treatment
measure: Median Progression-free Survival Time
timeFrame: 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.
measure: Overall Survival
timeFrame: 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.
Other outcomes:
Locations:
city: Mobile
country: United States
facility: MBCCOP - Gulf Coast
state: Alabama
city: Mobile
country: United States
facility: Providence Cancer Center at Providence Hospital
state: Alabama
city: Phoenix
country: United States
facility: Arizona Oncology Services Foundation
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic Scottsdale
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncology - Tucson
state: Arizona
city: Tucson
country: United States
facility: Arizona Cancer Center at University of Arizona Health Sciences Center
state: Arizona
city: Auburn
country: United States
facility: Auburn Radiation Oncology
state: California
city: Burbank
country: United States
facility: Providence Saint Joseph Medical Center - Burbank
state: California
city: Cameron Park
country: United States
facility: Radiation Oncology Centers - Cameron Park
state: California
city: Carmichael
country: United States
facility: Mercy Cancer Center at Mercy San Juan Medical Center
state: California
city: Chico
country: United States
facility: Enloe Cancer Center at Enloe Medical Center
state: California
city: Concord
country: United States
facility: Cancer Care Center at John Muir Health - Concord Campus
state: California
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center
state: California
city: Glendale
country: United States
facility: Glendale Adventist Medical Center
state: California
city: La Jolla
country: United States
facility: Rebecca and John Moores UCSD Cancer Center
state: California
city: Los Angeles
country: United States
facility: Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center and Hospital
state: California
city: Orange
country: United States
facility: St. Joseph Hospital Regional Cancer Center - Orange
state: California
city: Roseville
country: United States
facility: Radiation Oncology Center - Roseville
state: California
city: Sacramento
country: United States
facility: Radiological Associates of Sacramento Medical Group, Incorporated
state: California
city: Sacramento
country: United States
facility: University of California Davis Cancer Center
state: California
city: Sacramento
country: United States
facility: Mercy General Hospital
state: California
city: Stanford
country: United States
facility: Stanford Cancer Center
state: California
city: Turlock
country: United States
facility: Emanuel Regional Cancer Services at Emanuel Medical Center
state: California
city: Vacaville
country: United States
facility: Solano Radiation Oncology Center
state: California
city: Walnut Creek
country: United States
facility: John Muir/Mt. Diablo Comprehensive Cancer Center
state: California
city: Aurora
country: United States
facility: Rocky Mountain Cancer Centers - Aurora
state: Colorado
city: Colorado Springs
country: United States
facility: Rocky Mountain Cancer Centers - Colorado Springs
state: Colorado
city: Fort Collins
country: United States
facility: Poudre Valley Radiation Oncology
state: Colorado
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Newark
country: United States
facility: CCOP - Christiana Care Health Services
state: Delaware
city: Washington, D.C.
country: United States
facility: Washington Cancer Institute at Washington Hospital Center
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida Shands Cancer Center
state: Florida
city: Jacksonville Beach
country: United States
facility: Integrated Community Oncology Network
state: Florida
city: Jacksonville
country: United States
facility: Baptist Cancer Institute - Jacksonville
state: Florida
city: Jacksonville
country: United States
facility: Integrated Community Oncology Network at Southside Cancer Center
state: Florida
city: Jacksonville
country: United States
facility: Baptist Medical Center South
state: Florida
city: Orange Park
country: United States
facility: Integrated Community Oncology Network - Orange Park
state: Florida
city: Orlando
country: United States
facility: Florida Institute of Research, Medicine and Surgery Cancer Center
state: Florida
city: Palatka
country: United States
facility: Florida Cancer Center - Palatka
state: Florida
city: Saint Augustine
country: United States
facility: Flagler Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute of Emory University
state: Georgia
city: Columbus
country: United States
facility: John B. Amos Cancer Center
state: Georgia
city: Decatur
country: United States
facility: Veterans Affairs Medical Center - Atlanta (Decatur)
state: Georgia
city: Gainesville
country: United States
facility: Northeast Georgia Medical Center
state: Georgia
city: Arlington Heights
country: United States
facility: Northwest Community Hospital
state: Illinois
city: Chicago
country: United States
facility: John H. Stroger, Jr. Hospital of Cook County
state: Illinois
city: Springfield
country: United States
facility: Cancer Institute at St. John's Hospital
state: Illinois
city: Urbana
country: United States
facility: CCOP - Carle Cancer Center
state: Illinois
city: Anderson
country: United States
facility: Saint John's Cancer Center at Saint John's Medical Center
state: Indiana
city: Bloomington
country: United States
facility: Bloomington Hospital Regional Cancer Institute
state: Indiana
city: Fort Wayne
country: United States
facility: Radiation Oncology Associates Southwest
state: Indiana
city: Fort Wayne
country: United States
facility: Parkview Regional Cancer Center at Parkview Health
state: Indiana
city: Goshen
country: United States
facility: Center for Cancer Care at Goshen General Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Cancer Center
state: Indiana
city: Indianapolis
country: United States
facility: Methodist Cancer Center at Methodist Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Central Indiana Cancer Centers - East
state: Indiana
city: Indianapolis
country: United States
facility: Community Regional Cancer Care at Community Hospital East
state: Indiana
city: Indianapolis
country: United States
facility: Community Regional Cancer Care at Community Hospital North
state: Indiana
city: Muncie
country: United States
facility: Cancer Center at Ball Memorial Hospital
state: Indiana
city: South Bend
country: United States
facility: CCOP - Northern Indiana CR Consortium
state: Indiana
city: Iowa City
country: United States
facility: Holden Comprehensive Cancer Center at University of Iowa
state: Iowa
city: Overland Park
country: United States
facility: Kansas City Cancer Centers - Southwest
state: Kansas
city: Lexington
country: United States
facility: Lucille P. Markey Cancer Center at University of Kentucky
state: Kentucky
city: Louisville
country: United States
facility: Norton Suburban Hospital
state: Kentucky
city: Baltimore
country: United States
facility: Greenebaum Cancer Center at University of Maryland Medical Center
state: Maryland
city: Baltimore
country: United States
facility: St. Agnes Hospital Cancer Center
state: Maryland
city: Baltimore
country: United States
facility: Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
state: Maryland
city: Baltimore
country: United States
facility: Good Samaritan Hospital of Maryland
state: Maryland
city: Columbia
country: United States
facility: Central Maryland Oncology Center
state: Maryland
city: Glen Burnie
country: United States
facility: Tate Cancer Center at Baltimore Washington Medical Center
state: Maryland
city: Towson
country: United States
facility: Cancer Institute at St. Joseph Medical Center
state: Maryland
city: Boston
country: United States
facility: Boston University Cancer Research Center
state: Massachusetts
city: Commerce
country: United States
facility: Charach Cancer Center at Huron Valley - Sinai Hospital
state: Michigan
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Detroit
country: United States
facility: Josephine Ford Cancer Center at Henry Ford Hospital
state: Michigan
city: Flint
country: United States
facility: Great Lakes Cancer Institute at McLaren Regional Medical Center
state: Michigan
city: Grand Rapids
country: United States
facility: CCOP - Grand Rapids
state: Michigan
city: Livonia
country: United States
facility: St. Mary Mercy Hospital
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital - Royal Oak Campus
state: Michigan
city: Albert Lea
country: United States
facility: Albert Lea Cancer Center at Albert Lea Medical Center
state: Minnesota
city: Burnsville
country: United States
facility: Fairview Ridges Hospital
state: Minnesota
city: Coon Rapids
country: United States
facility: Mercy and Unity Cancer Center at Mercy Hospital
state: Minnesota
city: Edina
country: United States
facility: Fairview Southdale Hospital
state: Minnesota
city: Fridley
country: United States
facility: Mercy and Unity Cancer Center at Unity Hospital
state: Minnesota
city: Mankato
country: United States
facility: Immanuel St. Joseph's
state: Minnesota
city: Maplewood
country: United States
facility: Minnesota Oncology Hematology, PA - Maplewood
state: Minnesota
city: Minneapolis
country: United States
facility: Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
state: Minnesota
city: Robbinsdale
country: United States
facility: Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
city: Saint Cloud
country: United States
facility: CentraCare Clinic - River Campus
state: Minnesota
city: Saint Louis Park
country: United States
facility: CCOP - Metro-Minnesota
state: Minnesota
city: Saint Paul
country: United States
facility: United Hospital
state: Minnesota
city: Waconia
country: United States
facility: Ridgeview Medical Center
state: Minnesota
city: Pascagoula
country: United States
facility: Regional Cancer Center at Singing River Hospital
state: Mississippi
city: Kansas City
country: United States
facility: Kansas City Cancer Centers - South
state: Missouri
city: Kansas City
country: United States
facility: Kansas City Cancer Centers - North
state: Missouri
city: Saint Louis
country: United States
facility: CCOP - St. Louis-Cape Girardeau
state: Missouri
city: Springfield
country: United States
facility: Hulston Cancer Center at Cox Medical Center South
state: Missouri
city: Billings
country: United States
facility: CCOP - Montana Cancer Consortium
state: Montana
city: Billings
country: United States
facility: Northern Rockies Radiation Oncology Center
state: Montana
city: Billings
country: United States
facility: Billings Clinic - Downtown
state: Montana
city: Omaha
country: United States
facility: Methodist Estabrook Cancer Center
state: Nebraska
city: Omaha
country: United States
facility: Nebraska Medical Center
state: Nebraska
city: Las Vegas
country: United States
facility: CCOP - Nevada Cancer Research Foundation
state: Nevada
city: Reno
country: United States
facility: Renown Institute for Cancer at Renown Regional Medical Center
state: Nevada
city: Concord
country: United States
facility: Payson Center for Cancer Care at Concord Hospital
state: New Hampshire
city: Manchester
country: United States
facility: Elliot Regional Cancer Center at Elliot Hospital
state: New Hampshire
city: Bricktown
country: United States
facility: Ocean Medical Center at Meridian Health
state: New Jersey
city: Camden
country: United States
facility: Cancer Institute of New Jersey at Cooper University Hospital - Camden
state: New Jersey
city: Elizabeth
country: United States
facility: Trinitas Comprehensive Cancer Center at Trinitas Hospital
state: New Jersey
city: Jamesburg
country: United States
facility: Princeton Radiation Oncology Center
state: New Jersey
city: New Brunswick
country: United States
facility: Saint Peter's University Hospital
state: New Jersey
city: Princeton
country: United States
facility: University Medical Center at Princeton
state: New Jersey
city: Toms River
country: United States
facility: J. Phillip Citta Regional Cancer Center at Community Medical Center
state: New Jersey
city: Voorhees
country: United States
facility: Cancer Institute of New Jersey at Cooper - Voorhees
state: New Jersey
city: Albuquerque
country: United States
facility: Lovelace Medical Center - Downtown
state: New Mexico
city: Albuquerque
country: United States
facility: Radiation Oncology Associates, PA
state: New Mexico
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center
state: New Mexico
city: Albany
country: United States
facility: New York Oncology Hematology, PC at Albany Regional Cancer Care
state: New York
city: Albany
country: United States
facility: Veterans Affairs Medical Center - Albany
state: New York
city: Brooklyn
country: United States
facility: New York Methodist Hospital
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Canandaigua
country: United States
facility: Sands Cancer Center
state: New York
city: Manhasset
country: United States
facility: CCOP - North Shore University Hospital
state: New York
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: Rochester
country: United States
facility: Highland Hospital of Rochester
state: New York
city: Rochester
country: United States
facility: Lipson Cancer and Blood Center at Rochester General Hospital
state: New York
city: Rochester
country: United States
facility: University Radiation Oncology at Parkridge Hospital
state: New York
city: Rochester
country: United States
facility: James P. Wilmot Cancer Center at University of Rochester Medical Center
state: New York
city: Asheville
country: United States
facility: Mission Hospitals - Memorial Campus
state: North Carolina
city: Wilmington
country: United States
facility: New Hanover Radiation Oncology, PA
state: North Carolina
city: Minot
country: United States
facility: Trinity CancerCare Center
state: North Dakota
city: Akron
country: United States
facility: McDowell Cancer Center at Akron General Medical Center
state: Ohio
city: Akron
country: United States
facility: Summa Center for Cancer Care at Akron City Hospital
state: Ohio
city: Barberton
country: United States
facility: Barberton Citizens Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Charles M. Barrett Cancer Center at University Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Cancer Center at Fairview Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Center
state: Ohio
city: Columbus
country: United States
facility: Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
state: Ohio
city: Independence
country: United States
facility: Cleveland Clinic Cancer Center
state: Ohio
city: Maumee
country: United States
facility: Northwest Ohio Oncology Center
state: Ohio
city: Mayfield Heights
country: United States
facility: Hillcrest Cancer Center at Hillcrest Hospital
state: Ohio
city: Oregon
country: United States
facility: St. Charles Mercy Hospital
state: Ohio
city: Salem
country: United States
facility: Cancer Care Center, Incorporated
state: Ohio
city: Sandusky
country: United States
facility: North Coast Cancer Care, Incorporated
state: Ohio
city: Sylvania
country: United States
facility: Flower Hospital Cancer Center
state: Ohio
city: Toledo
country: United States
facility: Medical University of Ohio Cancer Center
state: Ohio
city: Toledo
country: United States
facility: CCOP - Toledo Community Hospital
state: Ohio
city: Toledo
country: United States
facility: St. Anne Mercy Hospital
state: Ohio
city: West Chester
country: United States
facility: Precision Radiotherapy at University Pointe
state: Ohio
city: Wooster
country: United States
facility: Cancer Treatment Center
state: Ohio
city: Wooster
country: United States
facility: Cleveland Clinic - Wooster
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma University Cancer Institute
state: Oklahoma
city: Eugene
country: United States
facility: Willamette Valley Cancer Center - Eugene
state: Oregon
city: Grants Pass
country: United States
facility: Three Rivers Community Hospital
state: Oregon
city: Medford
country: United States
facility: Dubs Cancer Center at Rogue Valley Medical Center
state: Oregon
city: Medford
country: United States
facility: Providence Cancer Center at PMCC
state: Oregon
city: Abington
country: United States
facility: Rosenfeld Cancer Center at Abington Memorial Hospital
state: Pennsylvania
city: Beaver
country: United States
facility: UPMC Cancer Center at Beaver Medical Center
state: Pennsylvania
city: Bethlehem
country: United States
facility: St. Luke's Cancer Network at St. Luke's Hospital
state: Pennsylvania
city: Bryn Mawr
country: United States
facility: Bryn Mawr Hospital
state: Pennsylvania
city: Clairton
country: United States
facility: UPMC Cancer Center at Jefferson Regional Medical Center
state: Pennsylvania
city: Clarion
country: United States
facility: Cancer Center at Clarion Hospital
state: Pennsylvania
city: Danville
country: United States
facility: Geisinger Cancer Institute at Geisinger Health
state: Pennsylvania
city: Drexel Hill
country: United States
facility: Delaware County Regional Cancer Center at Delaware County Memorial Hospital
state: Pennsylvania
city: Dunmore
country: United States
facility: Northeast Radiation Oncology Center
state: Pennsylvania
city: Gettysburg
country: United States
facility: Adams Cancer Center
state: Pennsylvania
city: Greensburg
country: United States
facility: UPMC Cancer Center - Arnold Palmer Pavilion
state: Pennsylvania
city: Hanover
country: United States
facility: Cherry Tree Cancer Center
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Cancer Institute at Milton S. Hershey Medical Center
state: Pennsylvania
city: Johnstown
country: United States
facility: UPMC Cancer Center at the John P. Murtha Pavilion
state: Pennsylvania
city: McKeesport
country: United States
facility: UPMC Cancer Center at UPMC McKeesport
state: Pennsylvania
city: Moon
country: United States
facility: UPMC - Moon
state: Pennsylvania
city: Natrona Heights
country: United States
facility: UPMC Cancer Center - Natrona Heights
state: Pennsylvania
city: New Castle
country: United States
facility: Jameson Memorial Hospital - North Campus
state: Pennsylvania
city: Philadelphia
country: United States
facility: Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center - Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Albert Einstein Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC - Shadyside
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Cancer Center at Magee-Womens Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Cancer Center at UPMC St. Margaret
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Cancer Center at UPMC Passavant
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Cancer Center - Upper St. Clair
state: Pennsylvania
city: Seneca
country: United States
facility: UPMC Cancer Center at UPMC Northwest
state: Pennsylvania
city: Uniontown
country: United States
facility: UPMC Cancer Center - Uniontown
state: Pennsylvania
city: Washington
country: United States
facility: Washington Hospital Cancer Center
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Cancer Center at Lankenau Hospital
state: Pennsylvania
city: York
country: United States
facility: York Cancer Center at Apple Hill Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Hollings Cancer Center at Medical University of South Carolina
state: South Carolina
city: Spartanburg
country: United States
facility: CCOP - Upstate Carolina
state: South Carolina
city: Rapid City
country: United States
facility: Rapid City Regional Hospital
state: South Dakota
city: Arlington
country: United States
facility: Texas Oncology, PA at Texas Cancer Center - Arlington South
state: Texas
city: Bedford
country: United States
facility: Texas Oncology, PA at Harris Center HEB
state: Texas
city: Dallas
country: United States
facility: Medical City Dallas Hospital
state: Texas
city: Dallas
country: United States
facility: Texas Oncology, PA at Texas Cancer Center Dallas Southwest
state: Texas
city: Dallas
country: United States
facility: Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
state: Texas
city: Denton
country: United States
facility: Texas Oncology, PA at Texas Cancer Center - Denton South
state: Texas
city: Fort Worth
country: United States
facility: Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital
state: Texas
city: Longview
country: United States
facility: Longview Cancer Center
state: Texas
city: Odessa
country: United States
facility: West Texas Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Cancer Care Centers of South Texas - Northeast
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: Sherman
country: United States
facility: Texas Oncology, PA at Texas Cancer Center - Sherman
state: Texas
city: Sugar Land
country: United States
facility: Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land
state: Texas
city: Tyler
country: United States
facility: Tyler Cancer Center
state: Texas
city: Murray
country: United States
facility: Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
state: Utah
city: Ogden
country: United States
facility: Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
state: Utah
city: Saint George
country: United States
facility: Dixie Regional Medical Center - East Campus
state: Utah
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists at UCS Cancer Center
state: Utah
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute at University of Utah
state: Utah
city: Burlington
country: United States
facility: Fletcher Allen Health Care - University Health Center Campus
state: Vermont
city: Charlottesville
country: United States
facility: University of Virginia Cancer Center
state: Virginia
city: Norfolk
country: United States
facility: Sentara Cancer Institute at Sentara Norfolk General Hospital
state: Virginia
city: Seattle
country: United States
facility: CCOP - Virginia Mason Research Center
state: Washington
city: Spokane
country: United States
facility: Cancer Care Northwest - Spokane South
state: Washington
city: Yakima
country: United States
facility: North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
state: Washington
city: Wheeling
country: United States
facility: Schiffler Cancer Center at Wheeling Hospital
state: West Virginia
city: Appleton
country: United States
facility: Theda Care Cancer Institute
state: Wisconsin
city: Green Bay
country: United States
facility: St. Vincent Hospital Regional Cancer Center
state: Wisconsin
city: La Crosse
country: United States
facility: Franciscan Skemp Healthcare - La Crosse Campus
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
state: Wisconsin
city: Marinette
country: United States
facility: Bay Area Cancer Care Center at Bay Area Medical Center
state: Wisconsin
city: Menomonee Falls
country: United States
facility: Community Memorial Hospital Cancer Care Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin Cancer Center
state: Wisconsin
city: Racine
country: United States
facility: All Saints Cancer Center at Wheaton Franciscan Healthcare
state: Wisconsin
city: Wausau
country: United States
facility: University of Wisconcin Cancer Center at Aspirus Wausau Hospital
state: Wisconsin
city: West Allis
country: United States
facility: West Allis Memorial Hospital
state: Wisconsin
city: Halifax
country: Canada
facility: Nova Scotia Cancer Centre
state: Nova Scotia
city: London
country: Canada
facility: London Regional Cancer Program at London Health Sciences Centre
state: Ontario
city: Montreal
country: Canada
facility: Maisonneuve-Rosemont Hospital
state: Quebec
city: Montreal
country: Canada
facility: Hopital Notre-Dame du CHUM
state: Quebec
city: Montreal
country: Canada
facility: McGill Cancer Centre at McGill University
state: Quebec
city: Quebec City
country: Canada
facility: Centre Hospitalier Universitaire de Quebec
state: Quebec
Study officials:
affiliation: Mayo Clinic
name: Paul D. Brown, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: M.D. Anderson Cancer Center
name: Christina A. Meyers, PhD
role: STUDY_CHAIR
affiliation: Bon Secours Cancer Institute at St. Mary's Hospital
name: Sherry Fox, RN, PhD
role: STUDY_CHAIR
affiliation: University of Wisconsin, Madison
name: Deepak Khuntia, MD
role: STUDY_CHAIR
References:
citation: 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.