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

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00566852
• Other study ID #: RTOG-0614
• Secondary ID: CDR0000577872NCI
• Status: Active, not recruiting
• Phase: Phase 3
• First received: December 1, 2007
• Last updated: March 26, 2015
• Start date: March 2008

Study information

• Verified date: March 2015
• Source: Radiation Therapy Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Memantine may be able to decrease side effects caused by whole-brain radiation therapy. It is not yet known if memantine is effective in preventing side effects caused by whole-brain radiation therapy.

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.

Description:

OBJECTIVES:

Primary

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

Secondary

• Determine whether the addition of memantine hydrochloride preserves cognitive function, specifically memory, as measured by the HVLT-delayed recall at 8 weeks, 16 weeks, and 12 months from the start of drug treatment.

• Determine whether the addition of memantine hydrochloride increases time to neurocognitive failure as measured by cognitive decline on a battery of tests including the HVLT for free recall, delayed recall, and delayed recognition; the Controlled Word Association Test (COWAT); the Trail Making Test Parts A and B (TMT); the Medical Outcomes Scale-Cognitive Functioning Subscale (MOS); and the Mini-Mental Status Examination (MMSE).

• Evaluate the potential benefit of memantine hydrochloride in change and overall quality of life, as measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br) subscale.

• Determine whether the addition of memantine hydrochloride increases progression-free survival.

• Determine whether the addition of memantine hydrochloride increases overall survival.

• Compare adverse events between the treatment arms according to the CTCAE v3.0 criteria.

• Collect serum, plasma, buffy coat cells, urine, and CSF for future translational research analyses.

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

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

• Arm II: Patients undergo WBRT as in arm I. Patients also receive oral placebo once daily beginning on day 1 of WBRT and continuing for 24 weeks.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 554
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

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

• If the original histologic proof of malignancy is > 5 years, then pathological (i.e., more recent) confirmation is required (e.g., from a systemic metastasis or brain metastasis)

• Brain metastases must be visible on contrast-enhanced MRI or a contrast enhanced CT scan (for patients unable to undergo MRI within the past 28 days)

• Patients unable to undergo MRI imaging because of non-compatible devices are eligible, provided the contrast-enhanced CT scans are obtained and are of sufficient quality

• Patients who had undergone radiosurgery or surgical resection and are planning adjuvant whole-brain radiotherapy do not have to have visible disease but do need a baseline MRI

• Must have stable systemic disease (i.e. no evidence of systemic disease progression within the past 3 months)

• Patients with brain metastases at initial presentation are eligible and do not need to demonstrate 3 months of stable scans

PATIENT CHARACTERISTICS:

Inclusion

• Karnofsky performance status 70-100%

• Serum creatinine = 3 mg/dL and creatinine clearance = 30 mL/min

• Total bilirubin = 2.5 mg/dL

• BUN < 20 mg/dL

• Mini-mental status exam score = 18

• Negative serum pregnancy test

• Fertile patients must practice adequate contraception

Exclusion

• Severe, active co-morbidity, defined as follows:

• Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months

• Transmural myocardial infarction within the last 6 months

• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration

• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration

• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

• Pregnant or lactating women

• Prior allergic reaction to memantine hydrochloride

• Current alcohol or drug abuse

• Intractable seizures while on adequate anticonvulsant therapy (i.e., more than one seizure per month for the past 2 months)

PRIOR CONCURRENT THERAPY:

Inclusion

• At least 14 days but no more than 56 days since prior therapy for brain metastasis, including radiosurgery and surgical resection

• No systemic chemotherapy for 14 days prior, during, or for 14 days after completion of whole-brain radiotherapy (WBRT)

Exclusion

• Prior cranial radiotherapy

• Patients may have received up to 3 prior WBRT treatments and still be registered and randomized on the protocol provided WBRT parameters meet protocol requirements

• Chronic short-acting benzodiazepine use

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cognitive/Functional Effects
• Metastatic Cancer
• Neoplasm Metastasis
• Neurotoxicity
• Neurotoxicity Syndromes
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Drug:
• memantine hydrochloride
Given orally

Other:
• placebo
Given orally

Radiation:
• radiation therapy
Patients undergo whole-brain radiotherapy (WBRT) 5 days a week for 3 weeks.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Radiation Therapy Oncology Group	National Cancer Institute (NCI), NRG Oncology

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive function, specifically memory, 24 weeks from the start of drug treatment as measured by the Hopkins Verbal Learning Test-Revised for delayed recall (HVLT-R-delayed recall)		Baseline to 24 weeks from the start of drug treatment	No
Secondary	Cognitive function, specifically memory, 8 weeks, 16 weeks, and 12 months from the start of treatment as measured by the HVLT-R-delayed recall		Baseline to 12 months from the start of drug treatment	No
Secondary	Neurocognitive failure as measured by a battery of tests		Baseline to 12 months from the start of drug treatment	No
Secondary	Quality-of-life as measured by the Functional Assessment of Cancer Therapy Brain subscale (FACT-Br)		Baseline to 12 months from the start of drug treatment	No
Secondary	Progression-free survival		From randomization to date of progression, death or last follow-up. Analysis occurs at the same time as the primary outcome.	No
Secondary	Overall survival		From randomization to date of death or last follow-up. Analysis occurs at the same time as the primary outcome.	No