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RTOG 9913 Protocol Information

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A Phase III Comparison of Biafiner to Declared Institutional Preference for Radiation Induced Skin Toxicity In Patients Undergoing Radiation Therapy for Advanced Squamous Cell Carcinomas of the Head and Neck
Protocol Documents
Current Version Date: 10/9/2000
Principal Investigator: Elizabeth Elliott, MRT(T)
Primary Objective:
  • To reduce radiation-induced acute skin toxicities in patients treated for head and neck cancers.
  • To determine whether Biafine®, used as a prophylactic agent is effective in reducing the proportion of  head and neck cancer patients that experience grade 2 or higher radiation-induced acute skin toxicity observed during therapy as measured by the CTC version 2.0 and the ONS Toxicity Scoring when compared to standard best supportive care.
Patient Population:
  • Patients with biopsy proven clinical stage III or IV, squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx for either radical radiation alone or post-operative treatment following primary surgical resection
  • Radiation doses equal to or greater than 50 Gy will be given
  • Zubrod Performance equal 0 and 1
  • No rash, ulceration or open wound in treatment field
  • No tumor involvement of the skin
  • No known skin allergy or sensitivity to Biafine®
  • No previous radiation therapy to the head and neck
  • No inflammatory or connective tissue disorders of the skin
  • No mental incompetence, including psychological or addictive disorders which would preclude completion of questionnaires
  • Amifostine use is not permitted
  • Patients on other RTOG studies are excluded
  • Signed study-specific consent form prior to randomization

 

Target Accrual: 498
Current Accrual: 547
Status: Terminated
Date: 1/16/2008
Participating Sites:
Advocate Lutheran General Hospital Park Ridge IL
Albany Medical Center Albany NY
Allan Blair Cancer Centre Regina, SK
Alta Bates Summit Medical Center-Herrick Campus Berkeley CA
Arizona Oncology Services Foundation Scottsdale AZ
Atlanta Regional CCOP Atlanta GA
Aurora Saint Luke's Medical Center Milwaukee WI
Baptist Cancer Institute Jacksonville FL
Baptist Health Madisonville/Merle Mahr Cancer Center Madisonville KY
Bay Area Tumor Institute Oakland CA
Bay Medical Center Panama City FL
Brooke Army Medical Center Fort Sam Houston TX
California Pacific Medical Center-Pacific Campus San Francisco CA
Cancer Center of Santa Barbara Santa Barbara CA
Cape Cod Hospital Hyannis MA
Central Illinois CCOP Decatur IL
Central Maryland Radiation Oncology in Howard County Columbia MD
Centre Hospitalier de l`Universite de Montreal-Notre Dame Montreal Quebec
Champlain Valley Physicians Hospital Medical Center Plattsburgh NY
Christiana Care Health System-Christiana Hospital Newark DE
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ) Quebec
CHUM - Centre Hospitalier de l'Universite de Montreal Montreal
Clarkson Hospital Omaha NE
Cleveland Clinic Akron General Akron OH
Cleveland Clinic Foundation Cleveland OH
Columbia Saint Mary's Water Tower Medical Commons Milwaukee WI
Community Medical Center Toms River NJ
Community Memorial Hospital Menomonee Falls WI
Cottonwood Hospital Medical Center Murray UT
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
Elliot Hospital Manchester NH
Enloe Medical Center Chico CA
Faxton-Saint Luke's Healthcare Utica NY
Finley Hospital Dubuque IA
Fox Chase Cancer Center Philadelphia PA
Froedtert and the Medical College of Wisconsin Milwaukee WI
Glendale Memorial Hospital and Health Center Glendale CA
Greenville Health System Cancer Institute-Eastside Greenville SC
Gulf Coast Cancer Treatment Center Panama City FL
Halifax Health Medical Center-Centers for Oncology Daytona Beach FL
Harbor Hospital Center Baltimore MD
Holmes Regional Medical Center Melbourne FL
Indiana University Health Bloomington Bloomington IN
Inspira Medical Center Vineland Vineland NJ
Jackson-Madison County General Hospital Jackson TN
John F Kennedy Medical Center Edison NJ
Juravinski Cancer Centre at Hamilton Health Sciences Hamilton, Ontario
Kalamazoo CCOP-West Michigan Cancer Center Kalamazoo MI
Kansas City CCOP Prairie Village KS
Kingston Health Sciences Centre Kingston, Ontario
LDS Hospital Salt Lake City UT
Lehigh Valley Hospital-Cedar Crest Allentown PA
Liberty Hospital Liberty MO
London Regional Cancer Program London Ontario
Louisiana State University Health Science Center New Orleans LA
M D Anderson Cancer Center Houston TX
Marshfield Clinic Marshfield WI
Mary Bird Perkins Cancer Center Baton Rouge LA
Massachusetts General Hospital Cancer Center Boston MA
Mayo Clinic Rochester MN
McGill University Department of Oncology Montreal
McLaren Cancer Institute-Flint Flint MI
Mercy Catholic Medical Center - Fitzgerald Darby PA
Metro-Minnesota CCOP St. Louis Park MN
Michigan Cancer Research Consortium Community Clinical Oncology Program Ann Arbor MI
Mills-Peninsula Medical Center San Mateo CA
Missouri Valley Cancer Consortium Omaha NE
Mobile Infirmary Medical Center Mobile AL
Moffitt Cancer Center Tampa FL
Monmouth Medical Center Long Branch NJ
Montefiore Medical Center - Moses Campus Bronx NY
Montgomery Cancer Center, LLC Montgomery AL
Mount Sinai Medical Center Miami Beach FL
Nebraska Methodist Hospital Omaha NE
North Shore-LIJ Health System CCOP Manhasset NY
Northridge Hospital Medical Center Northridge CA
Northwest Community Clinical Oncology Program Tacoma WA
Northwest Community Hospital Arlington Heights IL
Northwestern University Chicago IL
Ochsner Medical Center Jefferson New Orleans LA
Ohio State University Comprehensive Cancer Center Columbus OH
Oncology Institute of Greater Lafayette Lafayette IN
Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield Springfield MO
Pocono Medical Center East Strousburg PA
Pomona Valley Hospital Medical Center Pomona CA
Providence Alaska Medical Center Anchorage AK
Radiation Medical Group, Inc. San Diego CA
Radiological Associates of Sacramento Sacramento CA
Regional Hospital of Scranton Scranton PA
Richard L. Roudebush VA Medical Center Indianapolis IN
Romagosa Radiation Oncology Center Lafayette LA
Saint John Medical Center Tulsa OK
Saint Joseph Mercy Hospital Ann Arbor MI
Saint Louis University Hospital St. Louis MO
Saint Luke's University Hospital-Bethlehem Campus Bethlehem PA
Saint Mary's Hospital and Regional Medical Center Grand Junction CO
Saint Peter's University Hospital New Brunswick NJ
Saint Vincent Hospital Cancer Center Green Bay Green Bay WI
Santa Rosa Memorial Hospital CCOP Santa Rosa CA
Sarasota Radiation & Medical Oncology Center Sarasota FL
Saskatoon Cancer Centre Saskatoon, Saskatchew
Sentara Martha Jefferson Hospital Charlottesville VA
Southeast Cancer Control Consortium CCOP Winston Salem NC
Southwestern Vermont Medical Center Bennington VT
St Joseph's Hospital Medical Center Stockton CA
Stanford Cancer Institute Palo Alto Palo Alto CA
State University of New York Downstate Medical Center Brooklyn NY
Sutter Health Western Division Cancer Research Group Novato CA
The Research Institute of the McGill University Health Centr Montreal
Toledo Community Hospital Oncology Program CCOP Toledo OH
Trinity Cancer Care Center Minot ND
UCLA / Jonsson Comprehensive Cancer Center Los Angeles CA
UCSF Medical Center-Mount Zion San Francisco CA
UF Cancer Center at Orlando Health Orlando FL
Union Hospital Terre Haute IN
University Hospitals Parma Medical Center Parma OH
University of Alabama at Birmingham Cancer Center Birmingham AL
University of California Davis Comprehensive Cancer Center Sacramento CA
University of California San Diego LaJolla CA
University of Colorado Hospital Aurora CO
University of Florida Health Science Center - Gainesville Gainesville FL
University of Florida Health Science Center - Jacksonville Jacksonville FL
University of Maryland/Greenebaum Cancer Center Baltimore MD
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami FL
University of Missouri - Ellis Fischel Columbia MO
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 Texas Medical Branch Galveston TX
University of Vermont Medical Center Burlington VT
University of Wisconsin Hospital and Clinics Madison WI
UPMC-Mercy Hospital Pittsburgh PA
UPMC-Presbyterian Hospital Pittsburgh PA
Valley Hospital Paramus NJ
Vassar Brothers Medical Center Poughkeepsie NY
Veterans Administration Long Beach Medical Center Long Beach CA
Veterans Affairs Medical Center - Miami, Florida Miami FL
Virtua Memorial Mount Holly NJ
Wake Forest University Health Sciences Winston-Salem NC
Wayne State University/Karmanos Cancer Institute Detroit MI
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
Wilford Hall Medical Center Lackland AFB TX
Wyoming Valley Health Care System - Hospital Wilkes-Barre PA
Updated: 4/13/2011

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