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RTOG 0435 Protocol Information

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A Randomized, Phase III, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Palifermin (NSC# 740548) for the Reduction of Oral Mucositis in Patients with Locally Advanced Head and Neck Cancer Receiving Radiation Therapy with Con
Protocol Documents
Current Version Date: 5/23/2007
Principal Investigator: David I. Rosenthal, MD
Primary Objective:

To determine the burden of acute mucositis (defined to be 105 days [15 weeks] or less from the start of treatment) in patients receiving palifermin/placebo during concurrent chemoradiation for HNSCC

Patient Population:

Patients with selected Stage III or IVA-B squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx (excluding T1N1M0) who are receiving concurrent radiotherapy and chemotherapy

Target Accrual: 298
Current Accrual: 21
Status: Terminated
Date: 2/19/2009
Participating Sites:
ACR Clinical Research Center Philadelphia PA
Allegheny General Hospital Pittsburgh PA
Allegheny Valley Hospital Natrona Heights PA
Alta Bates Summit Medical Center - Summit Campus Oakland CA
Ascension Saint John Hospital Grosse Pointe Woods MI
Bay Area Medical Center Marinette WI
Bay Area Tumor Institute Oakland CA
Borgess Medical Center Kalamazoo MI
Boston Medical Center Boston MA
Bronson Methodist Hospital Kalamazoo MI
Cancer Treatment Center Wooster OH
Cape Cod Hospital Hyannis MA
Christiana Care Health System-Christiana Hospital Newark DE
City of Hope Comprehensive Cancer Center Duarte CA
Cleveland Clinic Akron General Akron OH
Coborn Cancer Center at Saint Cloud Hospital St. Cloud MN
Community Medical Center Toms River NJ
Cooper Health System-Voorhees Voorhees NJ
Cooper Hospital University Medical Center Camden NJ
Covenant Medical Center-Lakeside Lubbock TX
CoxHealth South Hospital Springfield MO
Cross Cancer Institute Edmonton, Alberta
Crozer-Chester Medical Center Upland PA
Dickinson County Healthcare System Iron Mountain MI
Dixie Medical Center Regional Cancer Center East St. George UT
Doctors Medical Center- JC Robinson Regional Cancer Center San Pablo CA
Duke University Medical Center Durham NC
Duke Women's Cancer Care Raleigh Raleigh NC
East Carolina University Greenville NC
East Bay Radiation Oncology Center Castro Valley CA
Enloe Medical Center Chico CA
Fox Chase Cancer Center Philadelphia PA
Franciscan St. James Health-Olympia Fields Campus Olympia Fields IL
Froedtert and the Medical College of Wisconsin Milwaukee WI
Genesys Hurley Cancer Institute Flint MI
Great Falls Clinic Great Falls MT
Green Bay Oncology at Saint Vincent Hospital Green Bay WI
Hematology Oncology Associates of Central New York-East Syracuse East Syracuse NY
Highland Hospital Rochester NY
Holy Cross Hospital Fort Lauderdale FL
Image-Guided Therapy QA Center (ITC) St. Louis MO
Inspira Medical Center Vineland Vineland NJ
Intercommunity Cancer Center Monroeville PA
Intermountain Medical Center Murray UT
IU Health Ball Memorial Hospital Muncie IN
Johnson City Medical Center Johnson City TN
Jupiter Medical Center Jupiter FL
Kalamazoo CCOP-West Michigan Cancer Center Kalamazoo MI
Kansas City CCOP Prairie Village KS
LDS Hospital Salt Lake City UT
Liberty Hospital Liberty MO
M D Anderson Cancer Center Houston TX
Margaret R Pardee Memorial Hospital Hendersonville NC
Mayo Clinic Rochester MN
Mayo Clinic in Arizona Scottsdale AZ
McGill University Department of Oncology Montreal
McKay-Dee Hospital Center Ogden UT
Mercy General Radiation Oncology Center Sacramento CA
Mercy Hospital Saint Louis St Louis MO
Mercy Hospital Springfield Springfield MO
Mercy San Juan Medical Center Carmichael CA
Michigan Cancer Research Consortium Community Clinical Oncology Program Ann Arbor MI
Mobile Infirmary Medical Center Mobile AL
Moffitt Cancer Center Tampa FL
Monmouth Medical Center Long Branch NJ
Montana Cancer Consortium CCOP Billings MT
Mount Nittany Medical Center State College PA
Mount Sinai Medical Center Miami Beach FL
Northern Rockies Radiation Oncology Center Billings MT
Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield Springfield MO
Penn State Milton S Hershey Medical Center Hershey PA
Poudre Valley Hospital Radiation Oncology Fort Collins CO
Providence St. Joseph Medical Center - Disney Family CA Ctr Burbank CA
Radiological Associates of Sacramento Sacramento CA
Radiological Physics Center (RPC) Houston TX
Rapid City Regional Hospital Rapid City SD
Rex Cancer Center Raleigh NC
Saint Agnes Hospital Baltimore MD
Saint John Macomb-Oakland Hospital Warren MI
Saint Joseph Mercy Hospital Ann Arbor MI
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
Sharon Regional Cancer Center Hermitage PA
Singing River Hospital Pascagoula MS
Somerset Oncology Center Somerset PA
Southeast Missouri Hospital Cape Girardeau MO
Southwest VA Regional Cancer Center Norton VA
St. Anthony's Health Alton IL
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
The James Graham Brown Cancer Center at University of Louisville Louisville KY
Torrance Memorial Medical Center Torrance CA
UH Seidman Cancer Center at Salem Regional Medical Center Salem OH
University of California Davis Comprehensive Cancer Center Sacramento CA
University of Maryland/Greenebaum Cancer Center Baltimore MD
University of Oklahoma Health Sciences Center Oklahoma City OK
University of Rochester Rochester NY
UP Health System Marquette Marquette MI
USC / Norris Comprehensive Cancer Center Los Angeles CA
Utah Cancer Specialists-Salt Lake City Salt Lake City UT
Utah Valley Regional Medical Center Provo UT
Valley Medical Oncology Consultants Pleasanton CA
Wayne State University/Karmanos Cancer Institute Detroit MI
Welch Cancer Center Sheridan WY
Wellmont Holston Valley Hospital and Medical Center Kingsport TN
Wheaton Franciscan Cancer Care-All Saints Racine WI
Wheeling Hospital/Schiffler Cancer Center Wheeling WV
William Beaumont Hospital-Royal Oak Royal Oak MI
Zablocki VA Medical Center-Wood Milwaukee WI
Updated: 4/8/2011

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