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RTOG 9806 Protocol Information

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A Phase II Study of Conventional Radiation Therapy Plus Thalidomide for Supratentorial Glioblastoma
Protocol Documents
Current Version Date: 3/24/2010
Principal Investigator: W.K. Alfred Yung, M.D.
Primary Objective:

To determine if thalidomide given orally once daily starting with conventional RT can improve the median survival time and time to progression of adults with supratentorial glioblastoma.

Patient Population:
  • Histopathologically-confirmed glioblastoma multiforme
  • The tumor must be supratentorial in location
  • Age ≥ 18
  • KPS ≥ 60
  • No prior radiation therapy to head or neck area, chemotherapy or radiosensitizer
  • Absolute neutrophil count ≥ 1500, platelets ≥ 100,000, BUN ≤ 25, Creatinine ≤ 1.5, Bilirubin ≤1.5 mg/dL, Hgb ≥ 10 gm, SGPT or SGOT 2 x normal range
  • No malignancy (within the past five years) except non-melanomatous skin cancer or carcinoma in-situ of the cervix
  • If present, sensory neuropathy must be grade 1.
  • Signed study -specific consent form

Required Sample Size: Arm 1, 36  Arm 2, 84

Target Accrual:
Current Accrual: 128
Status: Terminated
Date: 6/30/2010
Participating Sites:
21st Century Oncology Ft. Myers FL
Advocate Lutheran General Hospital Park Ridge IL
Arizona Oncology Services Foundation Scottsdale AZ
Baptist Cancer Institute Jacksonville FL
Baptist Health Paducah Paducah KY
Baptist Hospital of East Tennessee Knoxville TN
Bayfront Cancer Care Center St. Petersburg FL
California Cancer Center - North Fresno Fresno CA
Cancer Center of Santa Barbara Santa Barbara CA
Case Western Reserve University Cleveland OH
Central Illinois CCOP Decatur IL
Centre Hospitalier de l`Universite de Montreal-Notre Dame Montreal Quebec
Christiana Care Health System-Christiana Hospital Newark DE
CHUM - Centre Hospitalier de l'Universite de Montreal Montreal
City of Hope Comprehensive Cancer Center Duarte CA
Cleveland Clinic Akron General Akron OH
Cleveland Clinic Foundation Cleveland OH
Columbia Saint Mary's Water Tower Medical Commons Milwaukee WI
Columbus CCOP Columbus OH
Community Medical Center Toms River NJ
Community Memorial Hospital Menomonee Falls WI
Covenant Medical Center-Lakeside Lubbock TX
Cross Cancer Institute Edmonton, Alberta
Dartmouth-Hitchcock Medical Center/Norris Cotton Cancer Center Lebanon NH
Dayton CCOP Kettering OH
Dixie Medical Center Regional Cancer Center East St. George UT
Einstein Medical Center Philadelphia Philadelphia PA
Elizabeth General Medical Center Elizabeth NJ
Finley Hospital Dubuque IA
Froedtert and the Medical College of Wisconsin Milwaukee WI
Geisinger Medical Center Danville PA
Good Samaritan Hospital Corvallis OR
Greenville Health System Cancer Institute-Eastside Greenville SC
Gundersen Lutheran Medical Center La Crosse WI
Huntsville Hospital Huntsville AL
Indiana University Health Methodist Hospital Indianapolis IN
Ingalls Memorial Hospital Harvey IL
Jackson-Madison County General Hospital Jackson TN
John F Kennedy Medical Center Edison NJ
Joint Center For Radiation Therapy Boston MA
Juravinski Cancer Centre at Hamilton Health Sciences Hamilton, Ontario
Kalamazoo CCOP-West Michigan Cancer Center Kalamazoo MI
Kansas City CCOP Prairie Village KS
Laura and Isaac Perlmutter Cancer Center at NYU Langone New York NY
LDS Hospital Salt Lake City UT
Liberty Hospital Liberty MO
Loyola University Medical Center Maywood IL
M D Anderson Cancer Center Houston TX
Mainline Health CCOP Wynnewood PA
Massachusetts General Hospital Cancer Center Boston MA
McGill University Department of Oncology Montreal
Mesa Lutheran Hospital Mesa AZ
Methodist Medical Center of Illinois Peoria IL
Metro-Minnesota CCOP St. Louis Park MN
Michigan Cancer Research Consortium Community Clinical Oncology Program Ann Arbor MI
Mobile Infirmary Medical Center Mobile AL
Montefiore Medical Center - Moses Campus Bronx NY
Montgomery Cancer Center, LLC Montgomery AL
Mount Sinai Union Square New York NY
Nebraska Methodist Hospital Omaha NE
New York-Presbyterian/Brooklyn Methodist Hospital Brooklyn NY
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima WA
Northridge Hospital Medical Center Northridge CA
Northwest Community Clinical Oncology Program Tacoma WA
Northwestern University Chicago IL
Ochsner Medical Center Jefferson New Orleans LA
Ohio State University Comprehensive Cancer Center Columbus OH
Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield Springfield MO
Pomona Valley Hospital Medical Center Pomona CA
Radiation Oncology Affiliates of Maryland Baltimore MD
Radiological Associates of Sacramento Sacramento CA
Regional Hospital of Scranton Scranton PA
Saint Agnes Medical Center Fresno CA
Saint Joseph Mercy Hospital Ann Arbor MI
Saint Joseph Regional Medical Center-Mishawaka Mishawaka IN
Saint Luke's University Hospital-Bethlehem Campus Bethlehem PA
Saint Mary's of Michigan Saginaw MI
Saint Vincent Hospital Cancer Center Green Bay Green Bay WI
Santa Rosa Memorial Hospital CCOP Santa Rosa CA
Southeast Cancer Control Consortium CCOP Winston Salem NC
Southwestern Vermont Medical Center Bennington VT
Summa Akron City Hospital/Cooper Cancer Center Akron OH
Swedish Medical Center-First Hill Seattle WA
The Cancer Center for Southern Kentucky Bowling Green KY
The Research Institute of the McGill University Health Centr Montreal
Thomas Jefferson University Hospital Philadelphia PA
Trinity Cancer Care Center Minot ND
UCHealth Memorial Hospital Central Colorado Springs CO
UCLA / Jonsson Comprehensive Cancer Center Los Angeles CA
UF Cancer Center at Orlando Health Orlando FL
University of Alabama at Birmingham Cancer Center Birmingham AL
University of Kentucky/Markey Cancer Center Lexington KY
University of Pennsylvania Medical Center Philadelphia PA
University of Pennsylvania/Abramson Cancer Center Philadelphia PA
University of Rochester Rochester NY
University of South Alabama Mobile AL
University of Virginia Cancer Center Charlottesville VA
UP Health System Marquette Marquette MI
Upstate Carolina CCOP Spartanburg SC
Vassar Brothers Medical Center Poughkeepsie NY
Wake Forest University Health Sciences Winston-Salem NC
Washington Cancer Institute Washington DC
Washington University School of Medicine St. Louis MO
WellSpan Health-York Hospital York PA
West Penn Hospital Pittsburgh PA
Western Oncology Research Consortium Portland OR
Wheaton Franciscan Cancer Care-All Saints Racine WI
Wheeling Hospital/Schiffler Cancer Center Wheeling WV
Wyoming Valley Health Care System - Hospital Wilkes-Barre PA
Updated: 4/13/2011

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