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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: 1/26/2016
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: Terminated
Date: 12/15/2016
Participating Sites:
21st Century Oncology-Orange Park Orange Park FL
21st Century Oncology-Palatka Palatka FL
Abbott-Northwestern Hospital Minneapolis MN
Abington Memorial Hospital Abington PA
ACR Clinical Research Center Philadelphia PA
Allan Blair Cancer Centre Regina, SK
Allegiance Health Jackson MI
Alta Bates Summit Medical Center-Herrick Campus Berkeley CA
AnMed Health Cancer Center 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
Baptist Cancer Institute Jacksonville FL
Baptist Medical Center South Jacksonville FL
Baton Rouge General Medical Center Baton Rouge LA
Bay Area Medical Center Marinette WI
Bay Area Tumor Institute Oakland CA
Beaumont Hospital - Dearborn Dearborn MI
Boca Raton Regional Hospital Boca Raton FL
Borgess Medical Center Kalamazoo MI
Boston Medical Center Boston MA
Brigham and Women's Hospital Boston MA
Bronson Methodist Hospital Kalamazoo MI
Bryn Mawr Hospital Bryn Mawr PA
California Cancer Center - North Fresno Fresno CA
California Pacific Medical Center-Pacific Campus San Francisco CA
Cancer Care Manitoba Foundation Winnipeg, Manitoba
Carolinas Medical Center/Levine Cancer Institute Charlotte NC
CaroMont Regional Medical Center Gastonia NC
Centre Hospitalier de l`Universite de Montreal-Notre Dame Montreal Quebec
Christiana Care Health System-Christiana Hospital Newark DE
Cleveland Clinic Akron General Akron OH
Coborn Cancer Center at Saint Cloud Hospital St. Cloud MN
Community Howard Regional Health Kokomo IN
Community Medical Center Toms River NJ
Cone Health Cancer Center Greensboro NC
Cooper Hospital University Medical Center Camden NJ
Cottonwood Hospital Medical Center Murray UT
CoxHealth South Hospital Springfield MO
Cross Cancer Institute Edmonton, Alberta
Danville Regional Medical Center Danville VA
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
Duke University Medical Center Durham NC
East Carolina University Greenville NC
East Bay Radiation Oncology Center Castro Valley CA
Einstein Medical Center Philadelphia Philadelphia PA
Elkhart General Hospital Elkhart IN
Emory University Hospital Midtown Atlanta GA
Emory University Hospital/Winship Cancer Institute Atlanta GA
Fairview Ridges Hospital Burnsville MN
Fairview-Southdale Hospital Edina MN
Finley Hospital Dubuque IA
Fox Chase Cancer Center Philadelphia PA
Froedtert and the Medical College of Wisconsin Milwaukee WI
Froedtert Memorial Lutheran Hospital Milwaukee WI
Genesys Hurley Cancer Institute Flint MI
Grady Health System Atlanta GA
Grand Rapids Clinical Oncology Program Grand Rapids MI
Green Bay Oncology at Saint Vincent Hospital Green Bay WI
Green Bay Oncology Limited at Saint Mary's Hospital Green Bay WI
Greenville Health System Cancer Institute-Andrews Greenville SC
Greenville Health System Cancer Institute-Eastside Greenville SC
Gulf Coast Cancer Treatment Center Panama City FL
Gundersen Lutheran Medical Center La Crosse WI
Guthrie Medical Group PC-Robert Packer Hospital Sayre PA
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 Fort Lauderdale FL
Hunter Holmes McGuire Veterans Administration Medical Center Richmond VA
Huntsman Cancer Institute/University of Utah Salt Lake City UT
Hurley Medical Center Flint MI
Image-Guided Therapy QA Center (ITC) St. Louis MO
Ingalls Memorial Hospital Harvey IL
Inspira Medical Center Vineland Vineland NJ
Integrated Community Oncology Network-Flager Cancer Center St Augustine FL
Integrated Community Oncology Network-Florida Cancer Center Beaches Jacksonville Beach FL
Integrated Community Oncology Network-Southside Cancer Center Jacksonville FL
Iredell Memorial Hospital Statesville NC
IU Health La Porte Hospital La Porte IN
Jameson Health System North Campus New Castle PA
John B Amos Cancer Center Columbus GA
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore MD
Jupiter Medical Center Jupiter FL
Kalamazoo CCOP-West Michigan Cancer Center Kalamazoo MI
Kansas City CCOP Prairie Village KS
Lakeland Medical Center Saint Joseph St Joseph MI
Lankenau Medical Center Wynnewood PA
LDS Hospital Salt Lake City UT
Lexington Clinic Cancer Center Lexington KY
Liberty Hospital Liberty MO
Loma Linda University Medical Center Loma Linda CA
Louisiana State University Health Science Center New Orleans LA
Loyola University Medical Center Maywood IL
M D Anderson Cancer Center Houston TX
Mainline Health CCOP Wynnewood PA
Mary Bird Perkins Cancer Center Baton Rouge LA
Massachusetts General Hospital Cancer Center Boston MA
Mayo Clinic Rochester MN
Mayo Clinic in Arizona Scottsdale AZ
Mayo Clinic in Florida Jacksonville FL
McGill University Department of Oncology Montreal
McKay-Dee Hospital Center Ogden UT
McLaren Northern Michigan Petoskey MI
Medical University of South Carolina Charleston SC
Memorial Health University Medical Center Savannah GA
Memorial Hospital South Bend IN
Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood FL
Memorial Sloan Kettering Cancer Center New York NY
Mercy Catholic Medical Center - Fitzgerald Darby PA
Mercy General Radiation Oncology Center Sacramento CA
Mercy Health Saint Mary's Grand Rapids MI
Mercy Hospital Coon Rapids MN
Mercy Hospital Saint Louis St Louis MO
Mercy Hospital Springfield Springfield MO
Mercy San Juan Medical Center Carmichael CA
Methodist Hospital Philadelphia 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
Minnesota Oncology Hematology PA-Maplewood Maplewood MN
Mission Hospital-Memorial Campus Asheville NC
Mobile Infirmary Medical Center Mobile AL
Moffitt Cancer Center Tampa FL
Moorehead Memorial Hospital Eden NC
Mount Nittany Medical Center - Penn State Cancer Institute State College PA
Mount Sinai Medical Center Miami Beach FL
Munson Medical Center Traverse City MI
Nebraska Methodist Hospital Omaha NE
North Memorial Medical Health Center Robbinsdale MN
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima WA
Northeast Georgia Medical Center-Gainesville Gainesville GA
Northern Indiana Cancer Research Consortium South Bend IN
Northwestern Ontario Regional Cancer Centre Thunder Bay, Ontario
Novant Health Forsyth Medical Center Winston Salem NC
Ochsner Baptist Medical Center New Orleans LA
Ochsner Medical Center Jefferson New Orleans LA
Ohio State University Comprehensive Cancer Center Columbus OH
Orange Regional Medical Center Middletown NY
Oregon Health and Science University Portland OR
Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield Springfield MO
Paoli Memorial Hospital Paoli PA
PeaceHealth Saint Joseph Medical Center Bellingham WA
Penn State Milton S Hershey Medical Center Hershey PA
Pocono Medical 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 Hospital St. Paul MN
Research Medical Center Kansas City MO
Rex Cancer Center Raleigh NC
Rice Memorial Hospital Willmar MN
Ridgeview Medical Center Waconia MN
Roswell Park Cancer Institute Buffalo NY
Rush University Medical Center Chicago IL
Rutherford Hospital Rutherfordton NC
Saint John Hospital and Medical Center Grosse Pointe Woods MI
Saint John Macomb-Oakland Hospital Warren MI
Saint John Medical Center Tulsa OK
Saint John's Hospital - Healtheast Maplewood MN
Saint Joseph Mercy Hospital Ann Arbor MI
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 Hospital and Regional Medical Center Grand Junction CO
Saint Mary's of Michigan Saginaw MI
Saint Peter's University Hospital New Brunswick NJ
Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay WI
Saint Vincent Hospital Cancer Center Green Bay Green Bay WI
Scott and White Memorial Hospital Temple TX
Scottsdale Radiation Oncology Centers-Osborn Center Scottsdale AZ
Scottsdale Radiation Oncology Centers-Shea Center Scottsdale AZ
Southeast Missouri Hospital Cape Girardeau MO
Southwest VA Regional Cancer Center Norton VA
Sparrow Hospital Lansing MI
Spartanburg Medical Center Spartanburg SC
St Anne's Hospital Fall River MA
St Johns Hospital, Cancer Institute Springfield IL
St Joseph Hospital Mishawaka IN
St. Anthony's Health Alton IL
State University of New York Downstate Medical Center Brooklyn NY
State University of New York Upstate Medical University Syracuse NY
Summa Akron City Hospital/Cooper Cancer Center Akron OH
Sutter Cancer Centers Radiation Oncology Services-Auburn Auburn CA
Sutter Cancer Centers Radiation Oncology Services-Cameron Park Cameron Park CA
Sutter Cancer Centers Radiation Oncology Services-Roseville Roseville CA
Sutter Cancer Centers Radiation Oncology Services-Vacaville Vacaville CA
Sutter Health Western Division Cancer Research Group Novato CA
Sutter Medical Center Sacramento Sacramento CA
Tallahassee Memorial HealthCare Tallahassee FL
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
Torrance Memorial Medical Center Torrance CA
Tulane University Medical Center New Orleans LA
UF Cancer Center at Orlando Health Orlando FL
Union Hospital Terre Haute IN
United Hospital St. Paul MN
United Hospital St. Paul MN
Unity Hospital Fridley MN
University Hospital of Brooklyn at Long Island College Hospital Brooklyn NY
University Medical Center New Orleans New Orleans LA
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 Colorado Hospital Aurora CO
University of Florida Health Science Center - Gainesville Gainesville FL
University of Florida Health Science Center - Jacksonville Jacksonville FL
University of Kentucky/Markey Cancer Center Lexington KY
University of Maryland/Greenebaum Cancer Center Baltimore MD
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami FL
University of Minnesota/Masonic Cancer Center Minneapolis MN
University of Missouri - Ellis Fischel Columbia MO
University of Texas Southwestern Medical School Dallas TX
University of Washington Medical Center Seattle WA
University of Wisconsin Hospital and Clinics Madison WI
UP Health System Marquette Marquette MI
UPMC Cancer Center-John P. Murtha Pavilion Johnstown PA
UPMC Cancer Center-Natrona Heights Natrona Heights 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-Magee Womens Hospital Pittsburgh PA
UPMC-Mercy Hospital Pittsburgh PA
UPMC-Passavant Hospital Pittsburgh PA
UPMC-Presbyterian Hospital Pittsburgh PA
UPMC-Saint Margaret Pittsburgh PA
UPMC-Shadyside Hospital Pittsburgh PA
UPMC-The Washington Hospital Washington PA
Upstate Carolina CCOP Spartanburg SC
UT Southwestern/Simmons Cancer Center-Dallas Dallas TX
Utah Cancer Specialists-Salt Lake City 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/Massey Cancer Center Richmond VA
Virginia Mason CCOP Seattle WA
Virginia Mason Medical Center Seattle WA
Virtua Memorial Mount Holly NJ
Virtua Voorhees Voorhees NJ
Washington University School of Medicine St. Louis MO
Wayne Memorial Hospital Goldsboro NC
Wellmont Holston Valley Hospital and Medical Center Kingsport TN
WellSpan Health-York Hospital York PA
West Penn Hospital Pittsburgh PA
Wheaton Franciscan Cancer Care-All Saints Racine WI
Wheeling Hospital/Schiffler Cancer Center Wheeling WV
Yale-New Haven Hospital Saint Raphael Campus New Haven CT
Updated: 12/15/2016

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