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

Primary Purpose

Cognitive/Functional Effects, Metastatic Cancer, Neurotoxicity

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Memantine
Placebo
Whole brain radiation therapy
Sponsored by
Radiation Therapy Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cognitive/Functional Effects focused on measuring cognitive/functional effects, neurotoxicity, tumors metastatic to brain, unspecified adult solid tumor, protocol specific

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MBCCOP - Gulf Coast
  • Providence Cancer Center at Providence Hospital
  • Arizona Oncology Services Foundation
  • Mayo Clinic Scottsdale
  • Arizona Oncology - Tucson
  • Arizona Cancer Center at University of Arizona Health Sciences Center
  • Auburn Radiation Oncology
  • Providence Saint Joseph Medical Center - Burbank
  • Radiation Oncology Centers - Cameron Park
  • Mercy Cancer Center at Mercy San Juan Medical Center
  • Enloe Cancer Center at Enloe Medical Center
  • Cancer Care Center at John Muir Health - Concord Campus
  • City of Hope Comprehensive Cancer Center
  • Glendale Adventist Medical Center
  • Rebecca and John Moores UCSD Cancer Center
  • Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
  • USC/Norris Comprehensive Cancer Center and Hospital
  • St. Joseph Hospital Regional Cancer Center - Orange
  • Radiation Oncology Center - Roseville
  • Radiological Associates of Sacramento Medical Group, Incorporated
  • University of California Davis Cancer Center
  • Mercy General Hospital
  • Stanford Cancer Center
  • Emanuel Regional Cancer Services at Emanuel Medical Center
  • Solano Radiation Oncology Center
  • John Muir/Mt. Diablo Comprehensive Cancer Center
  • Rocky Mountain Cancer Centers - Aurora
  • Rocky Mountain Cancer Centers - Colorado Springs
  • Poudre Valley Radiation Oncology
  • Yale Cancer Center
  • CCOP - Christiana Care Health Services
  • Washington Cancer Institute at Washington Hospital Center
  • University of Florida Shands Cancer Center
  • Integrated Community Oncology Network
  • Baptist Cancer Institute - Jacksonville
  • Integrated Community Oncology Network at Southside Cancer Center
  • Baptist Medical Center South
  • Integrated Community Oncology Network - Orange Park
  • Florida Institute of Research, Medicine and Surgery Cancer Center
  • Florida Cancer Center - Palatka
  • Flagler Cancer Center
  • Winship Cancer Institute of Emory University
  • John B. Amos Cancer Center
  • Veterans Affairs Medical Center - Atlanta (Decatur)
  • Northeast Georgia Medical Center
  • Northwest Community Hospital
  • John H. Stroger, Jr. Hospital of Cook County
  • Cancer Institute at St. John's Hospital
  • CCOP - Carle Cancer Center
  • Saint John's Cancer Center at Saint John's Medical Center
  • Bloomington Hospital Regional Cancer Institute
  • Radiation Oncology Associates Southwest
  • Parkview Regional Cancer Center at Parkview Health
  • Center for Cancer Care at Goshen General Hospital
  • Indiana University Melvin and Bren Simon Cancer Center
  • Methodist Cancer Center at Methodist Hospital
  • Central Indiana Cancer Centers - East
  • Community Regional Cancer Care at Community Hospital East
  • Community Regional Cancer Care at Community Hospital North
  • Cancer Center at Ball Memorial Hospital
  • CCOP - Northern Indiana CR Consortium
  • Holden Comprehensive Cancer Center at University of Iowa
  • Kansas City Cancer Centers - Southwest
  • Lucille P. Markey Cancer Center at University of Kentucky
  • Norton Suburban Hospital
  • Greenebaum Cancer Center at University of Maryland Medical Center
  • St. Agnes Hospital Cancer Center
  • Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
  • Good Samaritan Hospital of Maryland
  • Central Maryland Oncology Center
  • Tate Cancer Center at Baltimore Washington Medical Center
  • Cancer Institute at St. Joseph Medical Center
  • Boston University Cancer Research Center
  • Charach Cancer Center at Huron Valley - Sinai Hospital
  • Barbara Ann Karmanos Cancer Institute
  • Josephine Ford Cancer Center at Henry Ford Hospital
  • Great Lakes Cancer Institute at McLaren Regional Medical Center
  • CCOP - Grand Rapids
  • St. Mary Mercy Hospital
  • William Beaumont Hospital - Royal Oak Campus
  • Albert Lea Cancer Center at Albert Lea Medical Center
  • Fairview Ridges Hospital
  • Mercy and Unity Cancer Center at Mercy Hospital
  • Fairview Southdale Hospital
  • Mercy and Unity Cancer Center at Unity Hospital
  • Immanuel St. Joseph's
  • Minnesota Oncology Hematology, PA - Maplewood
  • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
  • Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
  • Mayo Clinic Cancer Center
  • CentraCare Clinic - River Campus
  • CCOP - Metro-Minnesota
  • United Hospital
  • Ridgeview Medical Center
  • Regional Cancer Center at Singing River Hospital
  • Kansas City Cancer Centers - South
  • Kansas City Cancer Centers - North
  • CCOP - St. Louis-Cape Girardeau
  • Hulston Cancer Center at Cox Medical Center South
  • CCOP - Montana Cancer Consortium
  • Northern Rockies Radiation Oncology Center
  • Billings Clinic - Downtown
  • Methodist Estabrook Cancer Center
  • Nebraska Medical Center
  • CCOP - Nevada Cancer Research Foundation
  • Renown Institute for Cancer at Renown Regional Medical Center
  • Payson Center for Cancer Care at Concord Hospital
  • Elliot Regional Cancer Center at Elliot Hospital
  • Ocean Medical Center at Meridian Health
  • Cancer Institute of New Jersey at Cooper University Hospital - Camden
  • Trinitas Comprehensive Cancer Center at Trinitas Hospital
  • Princeton Radiation Oncology Center
  • Saint Peter's University Hospital
  • University Medical Center at Princeton
  • J. Phillip Citta Regional Cancer Center at Community Medical Center
  • Cancer Institute of New Jersey at Cooper - Voorhees
  • Lovelace Medical Center - Downtown
  • Radiation Oncology Associates, PA
  • University of New Mexico Cancer Center
  • New York Oncology Hematology, PC at Albany Regional Cancer Care
  • Veterans Affairs Medical Center - Albany
  • New York Methodist Hospital
  • Roswell Park Cancer Institute
  • Sands Cancer Center
  • CCOP - North Shore University Hospital
  • Long Island Jewish Medical Center
  • Highland Hospital of Rochester
  • Lipson Cancer and Blood Center at Rochester General Hospital
  • University Radiation Oncology at Parkridge Hospital
  • James P. Wilmot Cancer Center at University of Rochester Medical Center
  • Mission Hospitals - Memorial Campus
  • New Hanover Radiation Oncology, PA
  • Trinity CancerCare Center
  • McDowell Cancer Center at Akron General Medical Center
  • Summa Center for Cancer Care at Akron City Hospital
  • Barberton Citizens Hospital
  • Charles M. Barrett Cancer Center at University Hospital
  • Cleveland Clinic Cancer Center at Fairview Hospital
  • Cleveland Clinic Taussig Cancer Center
  • Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
  • Cleveland Clinic Cancer Center
  • Northwest Ohio Oncology Center
  • Hillcrest Cancer Center at Hillcrest Hospital
  • St. Charles Mercy Hospital
  • Cancer Care Center, Incorporated
  • North Coast Cancer Care, Incorporated
  • Flower Hospital Cancer Center
  • Medical University of Ohio Cancer Center
  • CCOP - Toledo Community Hospital
  • St. Anne Mercy Hospital
  • Precision Radiotherapy at University Pointe
  • Cancer Treatment Center
  • Cleveland Clinic - Wooster
  • Oklahoma University Cancer Institute
  • Willamette Valley Cancer Center - Eugene
  • Three Rivers Community Hospital
  • Dubs Cancer Center at Rogue Valley Medical Center
  • Providence Cancer Center at PMCC
  • Rosenfeld Cancer Center at Abington Memorial Hospital
  • UPMC Cancer Center at Beaver Medical Center
  • St. Luke's Cancer Network at St. Luke's Hospital
  • Bryn Mawr Hospital
  • UPMC Cancer Center at Jefferson Regional Medical Center
  • Cancer Center at Clarion Hospital
  • Geisinger Cancer Institute at Geisinger Health
  • Delaware County Regional Cancer Center at Delaware County Memorial Hospital
  • Northeast Radiation Oncology Center
  • Adams Cancer Center
  • UPMC Cancer Center - Arnold Palmer Pavilion
  • Cherry Tree Cancer Center
  • Penn State Cancer Institute at Milton S. Hershey Medical Center
  • UPMC Cancer Center at the John P. Murtha Pavilion
  • UPMC Cancer Center at UPMC McKeesport
  • UPMC - Moon
  • UPMC Cancer Center - Natrona Heights
  • Jameson Memorial Hospital - North Campus
  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
  • Fox Chase Cancer Center - Philadelphia
  • Albert Einstein Cancer Center
  • UPMC - Shadyside
  • UPMC Cancer Center at Magee-Womens Hospital
  • UPMC Cancer Center at UPMC St. Margaret
  • UPMC Cancer Center at UPMC Passavant
  • UPMC Cancer Center - Upper St. Clair
  • UPMC Cancer Center at UPMC Northwest
  • UPMC Cancer Center - Uniontown
  • Washington Hospital Cancer Center
  • Lankenau Cancer Center at Lankenau Hospital
  • York Cancer Center at Apple Hill Medical Center
  • Hollings Cancer Center at Medical University of South Carolina
  • CCOP - Upstate Carolina
  • Rapid City Regional Hospital
  • Texas Oncology, PA at Texas Cancer Center - Arlington South
  • Texas Oncology, PA at Harris Center HEB
  • Medical City Dallas Hospital
  • Texas Oncology, PA at Texas Cancer Center Dallas Southwest
  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
  • Texas Oncology, PA at Texas Cancer Center - Denton South
  • Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital
  • Longview Cancer Center
  • West Texas Cancer Center
  • Cancer Care Centers of South Texas - Northeast
  • University of Texas Health Science Center at San Antonio
  • Texas Oncology, PA at Texas Cancer Center - Sherman
  • Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land
  • Tyler Cancer Center
  • Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
  • Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
  • Dixie Regional Medical Center - East Campus
  • Utah Cancer Specialists at UCS Cancer Center
  • Huntsman Cancer Institute at University of Utah
  • Fletcher Allen Health Care - University Health Center Campus
  • University of Virginia Cancer Center
  • Sentara Cancer Institute at Sentara Norfolk General Hospital
  • CCOP - Virginia Mason Research Center
  • Cancer Care Northwest - Spokane South
  • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
  • Schiffler Cancer Center at Wheeling Hospital
  • Theda Care Cancer Institute
  • St. Vincent Hospital Regional Cancer Center
  • Franciscan Skemp Healthcare - La Crosse Campus
  • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
  • Bay Area Cancer Care Center at Bay Area Medical Center
  • Community Memorial Hospital Cancer Care Center
  • Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
  • Medical College of Wisconsin Cancer Center
  • All Saints Cancer Center at Wheaton Franciscan Healthcare
  • University of Wisconcin Cancer Center at Aspirus Wausau Hospital
  • West Allis Memorial Hospital
  • Nova Scotia Cancer Centre
  • London Regional Cancer Program at London Health Sciences Centre
  • Maisonneuve-Rosemont Hospital
  • Hopital Notre-Dame du CHUM
  • McGill Cancer Centre at McGill University
  • Centre Hospitalier Universitaire de Quebec

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

WBRT+Memantine

WBRT+Placebo

Arm Description

Whole brain radiation therapy (WBRT) and memantine

Whole brain radiation therapy (WBRT) and placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
December 1, 2007
Last Updated
July 21, 2017
Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI), NRG Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT00566852
Brief Title
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

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI), NRG Oncology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
554 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WBRT+Memantine
Arm Type
Experimental
Arm Description
Whole brain radiation therapy (WBRT) and memantine
Arm Title
WBRT+Placebo
Arm Type
Active Comparator
Arm Description
Whole brain radiation therapy (WBRT) and placebo
Intervention Type
Drug
Intervention Name(s)
Memantine
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Whole brain radiation therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in the Hopkins Verbal Learning Test - Revised for Delayed Recall (HVLT-R-delayed Recall) at 24 Weeks
Description
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.
Time Frame
Baseline and 24 weeks from the start of drug treatment
Secondary Outcome Measure Information:
Title
Change in the Hopkins Verbal Learning Test - Revised for Delayed Recall (HVLT-R-delayed Recall) at 8, 16, and 52 Weeks
Description
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.
Time Frame
Baseline, 8, 16, and 52 weeks from the start of drug treatment
Title
Median Time to Neurocognitive Failure
Description
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.
Time Frame
Baseline to 12 months from the start of drug treatment
Title
Change in Functional Assessment of Cancer Therapy With Brain Subscale (FACT-Br) at 24 Weeks
Description
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.
Time Frame
Baseline and 24 weeks from start of treatment
Title
Median Progression-free Survival Time
Description
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.
Time Frame
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.
Title
Overall Survival
Description
Failure for overall survival is death from any cause. Median survival was estimated using the Kaplan-Meier method.
Time Frame
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.

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
23956241
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.
Results Reference
derived
Links:
URL
http://neuro-oncology.oxfordjournals.org/content/15/10/1429.full
Description
Manuscript for primary analysis results

Learn more about this trial

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

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