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RTOG 9713 Protocol Information

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Phase III Randomized Study Comparing Best Supportive Care to Biafine® as a Prophylactic Agent for Radiation-Induced Skin Toxicity for Women Undergoing Breast Irradiation
Protocol Documents
Current Version Date: 4/17/1998
Principal Investigator: Jackie Fisher, R.N., B.S.N.
Primary Objective:

To determine whether Biafine is most effective in preventing and reducing radiation-induced dermatitis in selected women undergoing breast irradiation.

Patient Population:
  • Histologically confirmed diagnosis of breast carcinoma
  • No rash, ulceration, bleeding, or unhealed scar in treatment area
  • Minimal dose - 50.0 Gy including boost
  • KPS >/= 70
  • No medical contraindication (allergy or sensitivity) to Biafine or to the planned supportive care.
  • No prior RT, chemotherapy, or mastectomy
  • No concurrent chemotherapy (hormones allowed).
  • Ability to follow and comply with treatment regime.
  • No skin involvement by tumor
  • Use of bolus is prohibited
  • No history of, or current, connective tissue disorders.
  • Study-specific consent form
Target Accrual: 136
Current Accrual: 185
Status: Terminated
Date: 10/18/2002
Participating Sites:
Advocate Lutheran General Hospital Park Ridge IL
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
Baptist Health Paducah Paducah KY
Baptist Hospital of East Tennessee Knoxville TN
Bayfront Cancer Care Center St. Petersburg FL
Cape Cod Hospital Hyannis MA
Carle Cancer Center Urbana IL
Champlain Valley Physicians Hospital Medical Center Plattsburgh NY
Christiana Care Health System-Christiana Hospital Newark DE
Cleveland Clinic Foundation Cleveland OH
Columbus CCOP Columbus OH
Community Memorial Hospital Menomonee Falls WI
Dartmouth-Hitchcock Medical Center/Norris Cotton Cancer Center Lebanon NH
Dayton CCOP Kettering OH
Delaware County Memorial Hospital Drexel Hill PA
Dixie Medical Center Regional Cancer Center East St. George UT
Drexel University School of Medicine Philadelphia PA
East Jefferson General Hospital Metairie LA
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
Good Samaritan Hospital Corvallis OR
Grand View Hospital Sellersville PA
Greater Baltimore Medical Center Baltimore MD
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
Huntsville Hospital Huntsville AL
Indiana University Health Ball Memorial Hospital, Inc. Muncie IN
Inspira Medical Center Vineland Vineland NJ
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore MD
Kalamazoo CCOP-West Michigan Cancer Center Kalamazoo MI
Kansas City CCOP Prairie Village KS
Keesler Medical Center Keesler AFB MS
Laura and Isaac Perlmutter Cancer Center at NYU Langone New York NY
LDS Hospital Salt Lake City UT
Mainline Health CCOP Wynnewood PA
Mary Bird Perkins Cancer Center Baton Rouge LA
Mercy Regional Cancer Center Redding CA
Methodist Medical Center of Illinois Peoria IL
Miami Cancer Institute Miami FL
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
Morton Plant Hospital Clearwater FL
Mount Sinai Medical Center Miami Beach FL
Nebraska Methodist Hospital Omaha NE
New York Medical College Valhalla NY
North Shore-LIJ Health System CCOP Manhasset NY
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima WA
Northern Indiana Cancer Research Consortium South Bend IN
Pomona Valley Hospital Medical Center Pomona CA
Providence Alaska Medical Center Anchorage AK
Radiation Oncology Associates of Albuquerque Albuquerque NM
Regional Hospital of Scranton Scranton PA
Romagosa Radiation Oncology Center Lafayette LA
Saint Agnes Medical Center Fresno CA
Saint Francis Medical Center Trenton NJ
Saint Mary's of Michigan Saginaw MI
Saint Vincent Anderson Regional Hospital/Cancer Center Anderson IN
Saint Vincent Hospital Cancer Center Green Bay Green Bay WI
Sanford Roger Maris Cancer Center Fargo ND
Sentara Martha Jefferson Hospital Charlottesville VA
South Georgia Medical Center/Pearlman Cancer Center Valdosta GA
Southeast Cancer Control Consortium CCOP Winston Salem NC
Southwestern Vermont Medical Center Bennington VT
St Joseph's Hospital Milwaukee WI
State University of New York Downstate Medical Center Brooklyn NY
Summa Akron City Hospital/Cooper Cancer Center Akron OH
Sutter Health Western Division Cancer Research Group Novato CA
The Cancer Center for Southern Kentucky Bowling Green KY
The Christ Hospital Cincinnati OH
Thomas Jefferson University Hospital Philadelphia PA
Toledo Community Hospital Oncology Program CCOP Toledo OH
Trinity Cancer Care Center Minot ND
UCLA / Jonsson Comprehensive Cancer Center Los Angeles CA
UF Cancer Center at Orlando Health Orlando FL
UNC Lineberger Comprehensive Cancer Center Chapel Hill NC
University of Alabama at Birmingham Cancer Center Birmingham AL
University of Florida Health Science Center - Gainesville Gainesville FL
University of Kentucky/Markey Cancer Center Lexington KY
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami FL
University of New Mexico Cancer Center Albuquerque NM
University of Pennsylvania Medical Center Philadelphia PA
University of Rochester Rochester NY
University of South Alabama Mobile AL
Upstate Carolina CCOP Spartanburg SC
Vassar Brothers Medical Center Poughkeepsie NY
Virginia Commonwealth University/Massey Cancer Center Richmond VA
Virtua Memorial Mount Holly NJ
Wake Forest University Health Sciences Winston-Salem NC
West Penn Hospital Pittsburgh PA
Wheeling Hospital/Schiffler Cancer Center Wheeling WV
Wyoming Valley Health Care System - Hospital Wilkes-Barre PA
Updated: 4/13/2011

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