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RTOG 0024 Protocol Information

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Phase II Trial of Early Postoperative Paclitaxel Followed By Paclitaxel and Cisplatin Concurrent With Radiation Therapy for Resected, High-Risk Squamous Carcinoma of the Head and Neck
Protocol Documents
Current Version Date: 3/1/2004
Principal Investigator: David I. Rosenthal, M.D
Primary Objective:

To determine the feasibility of this treatment regimen, specifically the percentage of patients who can complete the combined treatment program.

Patient Population:

 

  • Any stage III or IV squamous carcinoma of the head and neck with gross total resection requiring postoperative XRT for high-risk factors OR planned surgery
  • No evidence of distant metastases
  • Zubrod Score 0 and 1
  • WBC>/=3,000; platelets >/=100,000
  • Creatinine, total bilirubin and AST or ALT</=1.5 X institutional upper limit of normal
  • Adequate nutritional status, as determined by the treating physicians in conjunction with consultation with clinical nutritionists as indicated
  • No prior chemotherapy or head and neck irradiation
  • No prior malignancy unless disease free for >/= 3 years
  • No active cardiac disease
  • No history of severe COPD requiring >/=3 hospitalizations over past year
  • No pregnant or nursing women due to the embryotoxic effects of chemotherapy
  • No pre-existing >/=grade 2 peripheral neurotoxicity
Target Accrual: 60
Current Accrual: 70
Status: Terminated
Date: 6/30/2010
Participating Sites:
Akron General Medical Center Akron OH
Allegheny General Hospital Pittsburgh PA
Arizona Oncology Services Foundation Scottsdale AZ
Baptist Hospital of East Tennessee Knoxville TN
Bay Area Medical Center Marinette WI
Bay Area Tumor Institute Oakland CA
Bay Medical Center Panama City FL
Cape Cod Hospital Hyannis MA
Caritas Regional Cancer Center Louisville KY
Case Western Reserve University Cleveland OH
Christiana Care Health System-Christiana Hospital Newark DE
Community Medical Center Toms River NJ
Community Memorial Hospital Menomonee Falls WI
Dartmouth Hitchcock Medical Center Lebanon NH
Dixie Medical Center Regional Cancer Center East St. George UT
Einstein Medical Center Philadelphia Philadelphia PA
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
Green Bay Oncology at Saint Vincent Hospital Green Bay WI
Gulf Coast Cancer Treatment Center Panama City FL
Gundersen Lutheran Medical Center La Crosse WI
Hunter Holmes McGuire Veterans Administration Medical Center Richmond VA
Indiana University Health Ball Memorial Hospital, Inc. Muncie IN
Ingalls Memorial Hospital Harvey IL
Inspira Medical Center Vineland Vineland NJ
Intermountain Medical Center Murray UT
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore MD
Kalamazoo CCOP-West Michigan Cancer Center Kalamazoo MI
Kansas City CCOP Prairie Village KS
Kentucky Clinic Berea Berea KY
LDS Hospital Salt Lake City UT
Liberty Hospital Liberty MO
Louisiana State University Health Science Center New Orleans LA
M D Anderson Cancer Center Houston TX
Mary Bird Perkins Cancer Center Baton Rouge LA
McKay-Dee Hospital Center Ogden UT
Mercy Catholic Medical Center - Fitzgerald Darby PA
Mercy Hospital Pittsburgh PA
Mercy Hospital Springfield Springfield MO
Methodist Cancer Center Omaha NE
Methodist Hospital Philadelphia PA
Methodist Medical Center of Illinois Peoria IL
Michigan Cancer Research Consortium Community Clinical Oncology Program Ann Arbor MI
Missouri Valley Cancer Consortium Omaha NE
Moffitt Cancer Center Tampa FL
Monmouth Medical Center Long Branch NJ
Mount Sinai Medical Center Miami Beach FL
Natalie Warren Bryant Cancer Center at Saint Francis Tulsa OK
Nevada Cancer Research Foundation CCOP Las Vegas NV
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
Rapid City Regional Hospital Rapid City SD
Regional Hospital of Scranton Scranton PA
Riddle Memorial Hospital Media PA
Roswell Park Cancer Institute Buffalo NY
Saint Joseph Mercy Hospital Ann Arbor MI
Saint Luke's University Hospital-Bethlehem Campus Bethlehem PA
Saint Mary's Hospital and Regional Medical Center Grand Junction CO
Saint Vincent Hospital Cancer Center Green Bay Green Bay WI
Sandra L Maxwell Cancer Center Cedar City UT
Santa Rosa Memorial Hospital CCOP Santa Rosa CA
Southeast Cancer Control Consortium CCOP Winston Salem NC
St. Claire Cancer Treatment Center Morehead KY
State University of New York Downstate Medical Center Brooklyn NY
Summa Akron City Hospital/Cooper Cancer Center Akron OH
The James Graham Brown Cancer Center at University of Louisville Louisville KY
The Toledo Hospital/Toledo Children's Hospital Toledo OH
Thomas Jefferson University Hospital Philadelphia PA
Toledo Community Hospital Oncology Program CCOP Toledo OH
Trinity Cancer Care Center Minot ND
Tulane University Medical Center New Orleans LA
UCSF Medical Center-Mount Zion San Francisco CA
University of Alabama at Birmingham Cancer Center Birmingham AL
University of California Davis Comprehensive Cancer Center Sacramento CA
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 Missouri - Ellis Fischel Columbia MO
University of Pennsylvania Medical Center Philadelphia PA
University of Pennsylvania/Abramson Cancer Center Philadelphia PA
University of Texas Medical Branch Galveston TX
University of Utah Health Science Center Salt Lake City UT
Upstate Carolina CCOP Spartanburg SC
Utah Cancer Specialists-Salt Lake City Salt Lake City UT
Utah Valley Regional Medical Center Provo UT
Veteran's Administration Medical Center - Lexington Lexington KY
Virginia Commonwealth University/Massey Cancer Center Richmond VA
Virginia Mason CCOP Seattle WA
Virginia Mason Medical Center Seattle WA
Virtua Memorial Mount Holly NJ
Wake Forest University Health Sciences Winston-Salem NC
Warren Radiation Therapy Center Warren NJ
Washington University School of Medicine St. Louis MO
WellSpan Health-York Hospital York PA
West Penn Hospital Pittsburgh PA
Wheeling Hospital/Schiffler Cancer Center Wheeling WV
Wyoming Valley Health Care System - Hospital Wilkes-Barre PA
Zablocki VA Medical Center-Wood Milwaukee WI
Updated: 4/8/2011

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