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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
Allan Blair Cancer Centre Regina, SK
Arizona Oncology Services Foundation Scottsdale AZ
Auburn Radiation Oncology Center Auburn CA
Bay Area Medical Center Marinette WI
Brigham and Women's Hospital/Dana Farber Cancer Institute Boston MA
CentraCare Health System/Coborn Cancer Center St. Cloud MN
Christiana Care Health Services, Inc. CCOP Newark DE
Fairview Ridges Hospital Burnsville MN
Fairview Southdale Hospital Edina MN
Florida Radiation Oncology Group - Baptist Regional Jacksonville FL
Forsyth Regional Medical Center Winston Salem NC
Fox Chase Cancer Center Philadelphia PA
Fox Chase Virtua Health Cancer Treatment Center Voorhees NJ
Grand Rapids Clinical Oncology Program (GRCOP) Grand Rapids MI
H. Lee Moffitt Cancer Center & Research Institute Tampa FL
Holy Cross Hospital Inc. Fort Lauderdale FL
Jupiter Medical Center Jupiter FL
Marshall Radiation Oncology Center Cameron Park CA
Massachusetts General Hospital Boston MA
Mayo Clinic Rochester MN
Mayo Clinic in Arizona Scottsdale AZ
Mayo Clinic in Florida Jacksonville FL
Medical College of Wisconsin Milwaukee WI
Medical University of South Carolina Charleston SC
Mercy General Radiation Oncology Center Sacramento CA
Mercy Hospital Coon Rapids MN
Mercy San Juan Radiation Oncology Center Carmichael CA
Methodist Cancer Center Omaha NE
Metro-MN CCOP St. Louis Park MN
Mount Sinai Comprehensive Cancer Center CCOP Miami Beach FL
North Memorial Medical Center Robbinsdale MN
Ohio State University Medical Center Columbus OH
PeaceHealth St. Joseph Cancer Center Bellingham WA
Radiological Associates of Sacramento Sacramento CA
Rice Memorial Hospital Willmar MN
Ridgeview Medical Center Waconia MN
Roseville Radiation Oncology Center Roseville CA
Roswell Park Cancer Institute Buffalo NY
Saint John's Hospital - HealthEast Maplewood MN
Saint Mary's Health Care/Hospital Grand Rapids MI
Solano Radiation Oncology Center Vacaville CA
Southwest Virginia Regional Cancer Center Norton VA
St. Mary's Hospital Medical Center Green Bay WI
St. Vincent Regional Cancer Center CCOP Green Bay WI
Thomas Jefferson University Hospital Philadelphia PA
United Hospital St. Paul MN
Unity Hospital Fridley MN
University of California Davis Medical Center Sacramento CA
University of Colorado Denver Aurora CO
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
Virginia Mason CCOP Seattle WA
Virtua-Memorial Hospital Burlington County, Inc. Mount Holly NJ
Washington University St. Louis MO
Wellmont Holston Valley Medical Center Kingsport TN
Updated: 4/16/2014

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