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RTOG 0234 Protocol Information

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A Phase II Randomized Trial of Surgery Followed by Chemoradiotherapy Plus C225 (Cetuximab) for Advanced Squamous Cell Carcinoma of the Head and Neck
Protocol Documents
Current Version Date: 4/3/2014
Principal Investigator: Paul M. Harari, MD
Primary Objective:

To evaluate, using a random assignment phase II design, two treatment regimens that utilize the EGFR inhibitor C225 in combination with chemoradiation in high-risk postoperative head and neck patients. This trial is designed to determine if either regimen is promising enough to be pursued in a subsequent phase III study. This decision will be primarily based on whether there is improvement in disease-free survival relative to the RTOG database of similar patients treated with chemoradiation in the completed intergroup trial RTOG 9501.

Patient Population:

Pathologic stage III or IV (note that the preoperative clinical stage may be I-IV if nodes are not appreciated) squamous carcinoma of the head and neck (site of tumor origin oral cavity, oropharynx, larynx, or hypopharynx) following gross total resection and requiring postoperative XRT for high-risk features

Target Accrual: 230
Current Accrual: 238
Status: Closed to Accrual
Date: 12/1/2006
Participating Sites:
Abbott Northwestern Hospital Minneapolis MN
Abington Memorial Hospital Abington PA
ACR Clinical Research Center Philadelphia PA
Akron City Hospital Akron OH
Akron General Medical Center Akron OH
Albert Einstein Medical Center Philadelphia PA
Allan Blair Cancer Centre Regina, SK
Allegiance Health/W.A. Foote Memorial Hospital Jackson MI
Alta Bates Hospital Comprehensive Cancer Center Berkeley CA
Anderson Memorial Hospital Anderson SC
Anne Arundel Medical Center Annapolis MD
Annie Penn Memorial Hospital Reidsville NC
Arizona Oncology Services Foundation Scottsdale AZ
Arlington Cancer Center Arlington TX
AtlantiCare Regional Medical Center Pomona NJ
Auburn Radiation Oncology Center Auburn CA
Baptist Cancer Institute Jacksonville FL
Baton Rouge General Medical Center Baton Rouge LA
Bay Area Medical Center Marinette WI
Bay Area Tumor Institute CCOP Oakland CA
Boca Raton Community Hospital-Lynn Regional Cancer Center Boca Raton FL
Borgess Medical Center Kalamazoo MI
Boston Medical Center MBCCOP Boston MA
Brigham and Women's Hospital/Dana Farber Cancer Institute Boston MA
Bronson Methodist Hospital Kalamazoo MI
Brooklyn MB-CCOP/SUNY Downstate Brooklyn NY
Bryn Mawr Hospital Bryn Mawr PA
California Cancer Center CGOP Fresno CA
California Pacific Medical Center San Francisco CA
Cancer Care Manitoba Foundation Winnipeg, Manitoba
Cancer Research for the Ozarks CCOP Springfield MO
Carolinas Medical Center/Levine Cancer Institute Charlotte NC
CentraCare Health System/Coborn Cancer Center St. Cloud MN
Centre Hospitalier de l`Université de Montréal-Notre Dame Montreal Quebec
Christiana Care Health Services, Inc. CCOP Newark DE
Community Howard Regional Health Kokomo IN
Community Medical Center Toms River NJ
Cone Health Cancer Center Greensboro NC
Cooper Health System Camden NJ
Cottonwood Hospital Murray UT
Cox Health System Springfield MO
Cross Cancer Institute Edmonton, Alberta
Danville Regional Medical Center Danville VA
Dartmouth Hitchcock Medical Center Lebanon NH
Dayton CCOP Kettering OH
Delaware County Memorial Hospital Drexel Hill PA
Dixie Medical Cancer Center East St. George UT
Duke University Medical Center Durham NC
East Bay Radiation Oncology Center Castro Valley CA
East Carolina Medical School Greenville NC
Elkhart General Hospital Elkhart IN
Ellis Fischel Cancer Center, University of Missouri Columbia MO
Emory University Atlanta GA
Emory University Hospital Midtown Atlanta GA
Fairview Ridges Hospital Burnsville MN
Fairview Southdale Hospital Edina MN
Fairview-University Medical Center Minneapolis MN
Forsyth Regional Medical Center Winston Salem NC
Fox Chase Cancer Center Philadelphia PA
Fox Chase Virtua Health Cancer Treatment Center Voorhees NJ
Froedtert Memorial Lutheran Hospital Milwaukee WI
Gaston Memorial Hospital Gastonia NC
Genesys Regional Medical Center Flint MI
Grady Memorial Hospital Atlanta GA
Grand Rapids Clinical Oncology Program (GRCOP) Grand Rapids MI
Green Bay Oncology - St. Mary's Hospital Green Bay WI
Green Bay Oncology at St. Vincent Hospital Green Bay WI
Greenville Health System Cancer Institute-Andrews Greenville SC
Greenville Health System Cancer Institute-International Greenville SC
Gulf Coast Cancer Treatment Center Panama City FL
Gunderson Clinic La Crosse WI
Guthrie Foundation (Robert Packer Hospital/Guthrie Clinic) Sayre PA
H. Lee Moffitt Cancer Center & Research Institute Tampa FL
Hartford Hospital Hartford CT
Hennepin County Medical Center Minneapolis MN
Henry Ford Hospital Detroit MI
Hillcrest Hospital Cancer Center Mayfield Heights OH
Holy Cross Hospital Inc. Fort Lauderdale FL
Hunter Holmes McGuire Veterans Hospital Richmond VA
Hurley Cancer Center Flint MI
ICON – Baptist Medical Center South Jacksonville FL
ICON – Cancer Center of Putnam Palatka FL
ICON – Flagler Cancer Center St Augustine FL
ICON – Florida Cancer Center - Beaches Jacksonville Beach FL
ICON – Orange Park Cancer Center Orange Park FL
ICON – Southside Cancer Center Jacksonville FL
Image-Guided Therapy QA Center (ITC) St. Louis MO
Ingalls Memorial Hospital Harvey IL
Interim LSU Public Hospital (ILH-NO) New Orleans LA
Iredell Memorial Hospital Statesville NC
Johns Hopkins Hospital Baltimore MD
Jupiter Medical Center Jupiter FL
Kalamazoo CCOP-West Michigan Cancer Center Kalamazoo MI
Kansas City CCOP Prairie Village KS
La Porte Hospital La Porte IN
Lakeland Hospital St Joseph MI
Lankenau Hospital Wynnewood PA
LDS Hospital Salt Lake City UT
Lexington Clinic Cancer Center Lexington KY
Liberty Hospital Liberty MO
Loma Linda University Cancer Institute Loma Linda CA
Loyola University Chicago Maywood IL
LSU Health Science Center-New Orleans MB-CCOP New Orleans LA
Main Line CCOP Wynnewood PA
Maplewood Cancer Center Maplewood MN
Marquette General Hospital Marquette MI
Marshall Radiation Oncology Center Cameron Park CA
Mary Bird Perkins Cancer Center Baton Rouge LA
Massachusetts General Hospital Boston MA
Mayo Clinic Rochester MN
Mayo Clinic in Arizona Scottsdale AZ
Mayo Clinic in Florida Jacksonville FL
McGill University Montreal
McKay-Dee Hospital Ogden UT
McLaren Northern Michigan Petoskey MI
MD Anderson Cancer Center Orlando Orlando FL
Medical College of Wisconsin Milwaukee WI
Medical University of South Carolina Charleston SC
Memorial Cancer Institute Hollywood FL
Memorial Hospital South Bend IN
Memorial Hospital Hollywood FL
Memorial Medical Center Savannah GA
Memorial Mission-St. Joseph`s Asheville NC
Memorial Sloan-Kettering Cancer Center New York NY
Mercy Catholic Medical Center - Fitzgerald Darby PA
Mercy General Radiation Oncology Center Sacramento CA
Mercy Hospital Coon Rapids MN
Mercy Hospital Pittsburgh PA
Mercy Hospital St. Louis St Louis MO
Mercy San Juan Radiation Oncology Center Carmichael CA
Mercy-Springfield Springfield MO
Methodist Cancer Center Omaha NE
Methodist Hospital Philadelphia PA
Metro-MN CCOP St. Louis Park MN
Michigan Cancer Research Consortium CCOP Ann Arbor MI
Mills-Peninsula Health Services San Mateo CA
Mobile Infirmary Medical Center Mobile AL
Moorehead Memorial Hospital Eden NC
Mount Nittany Medical Center - Penn State Cancer Institute State College PA
Mount Sinai Comprehensive Cancer Center CCOP Miami Beach FL
Munson Medical Center Traverse City MI
North Memorial Medical Center Robbinsdale MN
Northeast Georgia Medical Center Gainesville GA
Northern Indiana Cancer Research Consortium CCOP South Bend IN
Northwestern Ontario Regional Cancer Centre Thunder Bay, Ontario
Oakwood Healthcare Inc Dearborn MI
Ochsner Baptist Medical Center New Orleans LA
Ochsner Clinic CCOP New Orleans LA
Ohio State University Medical Center Columbus OH
Orange Regional Medical Center Middletown NY
Oregon Health & Science University Portland OR
Paoli Memorial Hospital Paoli PA
PeaceHealth St. Joseph Cancer Center Bellingham WA
Penn State University and The Milton S. Hershey Medical Ctr Hershey PA
Pocono Cancer Center East Strousburg PA
Pomona Valley Hospital Medical Center Pomona CA
Providence Holy Cross Medical Center Mission Hills CA
Providence St. Joseph Medical Center - Disney Family CA Ctr Burbank CA
Radiological Associates of Sacramento Sacramento CA
Radiological Physics Center (RPC) Houston TX
Randolph Hospital Ashboro NC
Rapid City Regional Hospital Rapid City SD
Reading Hospital Reading PA
Regions Radiation Therapy St. Paul MN
Research Medical Center Kansas City MO
Rex Cancer Center Raleigh NC
Rice Memorial Hospital Willmar MN
Ridgeview Medical Center Waconia MN
Roseville Radiation Oncology Center Roseville CA
Roswell Park Cancer Institute Buffalo NY
Rush University Medical Center Chicago IL
Rutherford Hospital Inc. Rutherfordton NC
Saint John's Hospital - HealthEast Maplewood MN
Saint Joseph Regional Medical Center South Bend In
Saint Joseph Regional Medical Center - Mishawaka Mishawaka IN
Saint Louis-Cape Girardeau CCOP Saint Louis MO
Saint Mary's Health Care/Hospital Grand Rapids MI
Scott and White Memorial Hospital Temple TX
Scottsdale Radiation Oncology Centers-Osborn Center Scottsdale AZ
Scottsdale Radiation Oncology Centers-Shea Center Scottsdale AZ
Solano Radiation Oncology Center Vacaville CA
South Jersey Hospital Systems Vineland NJ
Southeast Missouri Hospital Cape Girardeau MO
Southwest Virginia Regional Cancer Center Norton VA
Sparrow Regional Cancer Center Lansing MI
Spartanburg Regional Medical Center Spartanburg SC
St Anne's Hospital Fall River MA
St Johns Hospital, Cancer Institute Springfield IL
St Joseph Hospital Mishawaka IN
St Mary's Hospital & Medical Center Grand Junction CO
St. Anthony's Health Alton IL
St. John Health System, Inc. Tulsa OK
St. Johns Hospital & Medical Center Grosse Pointe Woods MI
St. Joseph Mercy Hospital Ann Arbor MI
St. Mary`s Medical Center Saginaw MI
St. Mary's Hospital Medical Center Green Bay WI
St. Peter's Medical Center New Brunswick NJ
St. Vincent Regional Cancer Center CCOP Green Bay WI
SUNY Upstate Medical University Syracuse NY
Sutter Health Western Division Cancer Research Group Novato CA
Tallahassee Memorial Hospital Tallahassee FL
The Cancer Center for Southern Kentucky Bowling Green KY
The Medical Center, Inc., John B. Amos Cancer Center Columbus GA
The Schiffler Cancer Center Wheeling WV
The Wendt Regional Cancer Center of the Finley Hospital Dubuque IA
Thomas Jefferson University Hospital Philadelphia PA
Torrance Memorial Medical Center Torrance CA
Tulane University Medical Center New Orleans LA
Union Hospital Terre Haute IN
United Hospital St. Paul MN
United Hospital St. Paul MN
Unity Hospital Fridley MN
Univ. Hospital of Brooklyn at Long Island College Hospital Brooklyn NY
University of Alabama at Birmingham Medical Center Birmingham AL
University of California Davis Medical Center Sacramento CA
University of Cincinnati Cincinnati OH
University of Colorado Denver Aurora CO
University of Florida College of Medicine Gainesville FL
University of Florida Health Science Center Jacksonville FL
University of Kentucky Hospital Lexington KY
University of Maryland Medical Systems Baltimore MD
University of Miami Miller School of Medicine Miami FL
University of Texas Southwestern Medical School Dallas TX
University of Texas Southwestern Medical School Dallas TX
University of Texas-MD Anderson Cancer Center Houston TX
University of Utah Health Science Center Salt Lake City UT
University of Washington Medical Center Seattle WA
University of Wisconsin Hospital Madison WI
UPMC Cancer Center-John P. Murtha Pavilion Johnstown PA
UPMC Cancer Center-Natrona Heights Natrona Heights PA
UPMC- Passavant Hospital Pittsburgh PA
UPMC-Arnold Palmer Pavilion Greensburg PA
UPMC-Heritage Valley Health System-Medical Center, (Beaver) Beaver PA
UPMC-HVHS Cancer Center (Moon) Coraopolis PA
UPMC-Jameson Memorial Hospital New Castle PA
UPMC-Magee Women's Hospital Pittsburgh PA
UPMC-Presbyterian Hospital Pittsburgh PA
UPMC-Shadyside Hospital Pittsburgh PA
UPMC-St. Margaret Pittsburgh PA
UPMC-The Washington Hospital Washington PA
Upstate Carolina CCOP - Gibbs Regional Cancer Center Spartanburg SC
Utah Cancer Specialists Salt Lake City UT
Utah Valley Regional Medical Center Provo UT
Valley Medical Oncology Consultants Pleasanton CA
Veterans Administration Hospital-East Orange Campus East Orange NJ
Virginia Commonwealth University Richmond VA
Virginia Mason CCOP Seattle WA
Virtua-Memorial Hospital Burlington County, Inc. Mount Holly NJ
Washington University St. Louis MO
Wayne Memorial Hospital Goldsboro NC
Webber Cancer Center Warren MI
Wellmont Holston Valley Medical Center Kingsport TN
Western Pennsylvania Hospital Pittsburgh PA
Wheaton Franciscan Cancer Care-All Saints Racine WI
Yakima Valley Memorial Hospital Yakima WA
Yale-New Haven Hospital Saint Raphael Campus New Haven CT
York Cancer Center York PA
Updated: 4/16/2014

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