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RTOG 9901 Protocol Information

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A Phase III Study to Test the Efficacy and Safety of GM-CSF to Reduce the Severity and Duration of Mucosal Injury and Pain (Mucositis) Associated With Curative Radiation Therapy in Head and Neck Cancer Patients
Protocol Documents
Current Version Date: 4/30/2001
Principal Investigator: Francis LeVeque, D.D.S.
Primary Objective:

To reduce the severity of mucosal injury in the oral cavity and oropharynx as measured by an objective site-specific grading tool and standard National Cancer Institute Common Toxicity Criteria (NCI-CTC).

Patient Population:
  • Confirmed histopathologic diagnosis of head and neck carcinoma excluding T1-T2 glottic tumors, as long as treatment includes ≥ 50% of oral pharynx, oral cavity, or both. Neck metastases from an unknown primary are eligible if the dose to ≥ 50% of the salivary gland is ≥ 50 Gy.
  • Karnofsky Performance Score ≥ 60
  • No prior radiotherapy to the head and neck
  • Planned irradiation to total dose 60-70 Gy at 1.8-2.0 Gy/day, five days a week for 6-7 weeks.
  • Pregnant or lactating females are not eligible
  • No T1 or T2 glottic tumors
  • No history of allergy or idiosyncratic response to GM -CSF
  • No residual oral/oropharyngeal mucosal injury from chemotherapy
  • Not using any of these oral care medications during RT: Amifostine (Ethyol), Chlorhexidine Gluconate (Peridex), Sucralfate tablets or slurry (Carafate), Benzydamine HCL rinses, or selective decontamination of the oral cavity (i.e., IB-367)
  • Cannot be enrolled on other RTOG head and neck studies
  • Other than concurrent cisplatin, no other chemotherapy agent is allowed
  • Not HIV positive
  • Signed study-specific consent form prior to randomization

 

Target Accrual: 126
Current Accrual: 130
Status: Terminated
Date: 1/16/2008
Participating Sites:
Adena Regional Medical Center Chillicothe OH
Allegiance Health Jackson MI
Arizona Oncology Services Foundation Scottsdale AZ
Atlanta Regional CCOP Atlanta GA
Aurora Saint Luke's Medical Center Milwaukee WI
Baton Rouge General Medical Center Baton Rouge LA
Bay Area Tumor Institute Oakland CA
Bay Medical Center Panama City FL
California Cancer Center CGOP Fresno CA
Central Illinois CCOP Decatur IL
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke, Quebec
Champlain Valley Physicians Hospital Medical Center Plattsburgh NY
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ) Quebec
Columbia Saint Mary's Water Tower Medical Commons Milwaukee WI
Columbus CCOP Columbus OH
Community Medical Center Toms River NJ
Cottonwood Hospital Medical Center Murray UT
Dayton CCOP Kettering OH
Deaconess Medical Center Spokane WA
Dixie Medical Center Regional Cancer Center East St. George UT
Doctors Hospital Columbus OH
Don & Sybil Harrington Cancer Center Amarillo TX
East Bay Radiation Oncology Center Castro Valley CA
Einstein Medical Center Philadelphia Philadelphia PA
Elliot Hospital Manchester NH
Enloe Medical Center Chico CA
Finley Hospital Dubuque IA
Genesys Hurley Cancer Institute Flint MI
Grady Memorial Hospital Delaware OH
Grant Medical Center Columbus OH
Gulf Coast Cancer Treatment Center Panama City FL
Gundersen Lutheran Medical Center La Crosse WI
Halifax Hospital ROC Daytona Beach FL
Harbor Hospital Center Baltimore MD
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
LDS Hospital Salt Lake City UT
Lehigh Valley Hospital-Cedar Crest Allentown PA
Liberty Hospital Liberty MO
Licking Memorial Hospital Newark OH
Louisiana State University Health Science Center New Orleans LA
Lutheran General Hospital Park Ridge IL
Mainline Health CCOP Wynnewood PA
Margaret R Pardee Memorial Hospital Hendersonville NC
Marietta Memorial Hospital Marietta OH
Mary Bird Perkins Cancer Center Baton Rouge LA
McGill University Department of Oncology Montreal
McLaren Cancer Institute - Flint Flint MI
Mercy Catholic Medical Center - Fitzgerald Darby PA
Mercy Hospital Pittsburgh PA
Mercy Hospital Springfield Springfield MO
Methodist Cancer Center Omaha NE
Metro-Minnesota CCOP St. Louis Park MN
Michigan Cancer Research Consortium Community Clinical Oncology Program Ann Arbor MI
Montefiore Medical Center - Moses Campus Bronx NY
Mount Carmel Health Center West Columbus OH
Mount Sinai Medical Center Miami Beach FL
New York-Presbyterian/Brooklyn Methodist Hospital Brooklyn NY
North Shore-LIJ Health System CCOP Manhasset NY
Northern Indiana Cancer Research Consortium South Bend IN
Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield Springfield MO
Penn State University and The Milton S. Hershey Medical Ctr Hershey PA
Pomona Valley Hospital Medical Center Pomona CA
Providence Holy Cross Medical Center Mission Hills CA
Radiation Oncology Associates of Albuquerque Albuquerque NM
Radiological Associates of Sacramento Sacramento CA
Rapid City Regional Hospital Rapid City SD
Richard L. Roudebush VA Medical Center Indianapolis IN
Saint John Hospital and Medical Center Grosse Pointe Woods MI
Saint John Macomb-Oakland Hospital Warren MI
Saint Joseph Mercy Hospital Ann Arbor MI
Saint Luke's University Hospital-Bethlehem Campus Bethlehem PA
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
Springfield Regional Medical Center Springfield OH
St Anne's Hospital Fall River MA
St Joseph's Hospital Medical Center Stockton CA
St. Vincent Anderson Regional Hospital, Inc. Anderson IN
State University of New York Downstate Medical Center Brooklyn NY
The Christ Hospital Cincinnati OH
Toledo Community Hospital Oncology Program CCOP Toledo OH
Trinity Cancer Care Center Minot ND
Union Hospital Terre Haute IN
University of Alabama at Birmingham Cancer Center Birmingham AL
University of California Davis Comprehensive Cancer Center Sacramento CA
University of Cincinnati/Barrett Cancer Center Cincinnati OH
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami FL
University of Michigan Comprehensive Cancer Center Ann Arbor MI
University of Missouri - Ellis Fischel Columbia MO
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
University of Texas Medical Branch Galveston TX
Valley Medical Oncology Consultants Pleasanton CA
Veterans Administration Hospital-East Orange Campus East Orange NJ
Veterans Administration Long Beach Medical Center Long Beach CA
Virtua Memorial Mount Holly NJ
Wake Forest University Health Sciences Winston-Salem NC
Warren Radiation Therapy Center Warren NJ
Wayne State University/Karmanos Cancer Institute Detroit MI
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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