A Phase II Randomized Trial Of Surgery Followed By Chemoradiotherapy Plus Cetuximab For Advanced Squamous Cell Carcinoma Of The Head and Neck
OBJECTIVES:
Primary
- Compare disease-free survival of patients with resected stage III or IV squamous cell
carcinoma or lymphoepithelioma of the head and neck treated with adjuvant cetuximab in
combination with chemoradiotherapy comprising docetaxel vs cisplatin.
Secondary
- Compare the safety and efficacy of these regimens in these patients.
- Compare locoregional control and overall survival rates in patients treated with these
regimens.
- Correlate epidermal growth factor receptor (total and phosphorylated), pMAPK, pAKT,
Stat-3, Ki-67, cyclo-oxygenase-2, and cyclin B1 expression with outcome in patients
treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
Zubrod performance status (0 vs 1), risk category (positive margins vs high risk [i.e., ≥ 2
positive nodes or extracapsular nodal extension]) and use of intensity-modulated
radiotherapy (no vs yes). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive cetuximab IV over 2 hours on day 1 (week 1). Patients then
receive cetuximab IV over 1 hour and cisplatin IV over 1 hour before radiotherapy on
days 8, 15, 22, 29, 36, and 43 (weeks 2-7). Patients undergo radiotherapy once daily, 5
days a week, beginning on day 8 for a total of 6 weeks (weeks 2-7).
- Arm II: Patients receive cetuximab and undergo radiotherapy as in arm I. Patients also
receive docetaxel IV over 30 minutes before radiotherapy on days 8, 15, 22, 29, 36, and
43 (weeks 2-7).
Treatment in both arms continues in the absence of disease progression or unacceptable
toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 4 years, and
then annually thereafter.
PROJECTED ACCRUAL: A total of 230 patients (115 per treatment arm) will be accrued for this
study within approximately 29 months.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Disease-free survival
No
Paul M. Harari, MD
Study Chair
University of Wisconsin, Madison
United States: Federal Government
CDR0000360850
NCT00084318
April 2004
Name | Location |
---|---|
Akron City Hospital | Akron, Ohio 44304 |
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Mayo Clinic Scottsdale | Scottsdale, Arizona 85259 |
Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
Hurley Medical Center | Flint, Michigan 48503 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Veterans Affairs Medical Center - East Orange | East Orange, New Jersey 07018-1095 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
Fairview Southdale Hospital | Edina, Minnesota 55435 |
Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse, Wisconsin 54601 |
Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294-3300 |
Providence Saint Joseph Medical Center - Burbank | Burbank, California 91505 |
CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
CCOP - MainLine Health | Wynnewood, Pennsylvania 19096 |
CCOP - Greenville | Greenville, South Carolina 29615 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver, Colorado 80010 |
University of Miami Sylvester Comprehensive Cancer Center | Miami, Florida 33136 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | Columbus, Ohio 43210-1240 |
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
CCOP - Scott and White Hospital | Temple, Texas 76508 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
CCOP - Virginia Mason Research Center | Seattle, Washington 98101 |
Utah Valley Regional Medical Center - Provo | Provo, Utah 84604 |
Veterans Affairs Medical Center - Richmond | Richmond, Virginia 23249 |
University of California Davis Cancer Center | Sacramento, California 95817 |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
Mobile Infirmary Medical Center | Mobile, Alabama 36640-0460 |
Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington, Kentucky 40536-0084 |
Cancer Research Center at Boston Medical Center | Boston, Massachusetts 02118 |
Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
Thompson Cancer Survival Center | Knoxville, Tennessee 37916 |
Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
McDowell Cancer Center at Akron General Medical Center | Akron, Ohio 44307 |
M.D. Anderson Cancer Center at University of Texas | Houston, Texas 77030 |
Latter Day Saints Hospital | Salt Lake City, Utah 84143 |
Loma Linda University Cancer Institute at Loma Linda University Medical Center | Loma Linda, California 92354 |
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia 31403-3089 |
SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
Mission Hospitals - Memorial Campus | Asheville, North Carolina 28801 |
Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
Saint Peter's University Hospital | New Brunswick, New Jersey 08901-1780 |
Mount Nittany Medical Center | State College, Pennsylvania 16803 |
St. Mary's Hospital Medical Center - Green Bay | Green Bay, Wisconsin 54303 |
Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay, Wisconsin 54303 |
Bay Area Cancer Care Center at Bay Area Medical Center | Marinette, Wisconsin 54143 |
Torrance Memorial Medical Center | Torrance, California 90505 |
Tallahassee Memorial Hospital | Tallahassee, Florida 32308 |
Baptist Cancer Institute - Jacksonville | Jacksonville, Florida 32207 |
Saint Anthony's Hospital at Saint Anthony's Health Center | Alton, Illinois 62002 |
Good Samaritan Regional Health Center | Mt. Vernon, Illinois 62864 |
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital | Gape Girardeau, Missouri 63701 |
David C. Pratt Cancer Center at St. John's Mercy | St. Louis, Missouri 63141 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
Cottonwood Hospital Medical Center | Murray, Utah 84107 |
McKay-Dee Hospital Center | Ogden, Utah 84403 |
Utah Cancer Specialists at UCS Cancer Center | Salt Lake City, Utah 84106 |
University Cancer Center at University of Washington Medical Center | Seattle, Washington 98195 |
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph | Saint Joseph, Michigan 49085 |
Virginia Commonwealth University Massey Cancer Center | Richmond, Virginia 23298-0037 |
Huntsman Cancer Institute at University of Utah | Salt Lake City, Utah 84112 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton, New Jersey 08053 |
Fox Chase Virtua Health Cancer Program at Virtua West Jersey | Voorhees, New Jersey 08043 |
Hillcrest Cancer Center at Hillcrest Hospital | Mayfield Heights, Ohio 44124 |
Rosenfeld Cancer Center at Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Fox Chase Cancer Center - Philadelphia | Philadelphia, Pennsylvania 19111-2497 |
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital | Fort Lauderdale, Florida 33308 |
Ella Milbank Foshay Cancer Center at Jupiter Medical Center | Jupiter, Florida 33458 |
Ingalls Cancer Care Center at Ingalls Memorial Hospital | Harvey, Illinois 60426 |
Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital | Ann Arbor, Michigan 48106-0995 |
Upper Michigan Cancer Center at Marquette General Hospital | Marquette, Michigan 49855 |
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital | Minneapolis, Minnesota 55407 |
Hubert H. Humphrey Cancer Center at North Memorial Medical Center | Robbinsdale, Minnesota 55422-2900 |
Coborn Cancer Center | Saint Cloud, Minnesota 56303 |
CentraCare Clinic - River Campus | St. Cloud, Minnesota 56303 |
Park Nicollet Health Services | St. Louis Park, Minnesota 55416 |
Saint Francis Medical Center | Cape Girardeau, Missouri 63701 |
Iredell Memorial Hospital | Statesville, North Carolina 28677 |
Forsyth Regional Cancer Center at Forsyth Medical Center | Winston-Salem, North Carolina 27103 |
Bryn Mawr Hospital | Bryn Mawr, Pennsylvania 19010 |
Lankenau Cancer Center at Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
Bon Secours St. Francis Health System | Greenville, South Carolina 29601 |
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center | Kingsport, Tennessee 37662 |
Dixie Regional Medical Center - East Campus | Saint George, Utah 84770 |
Danville Regional Medical Center | Danville, Virginia 24541 |
Green Bay Oncology, Limited at St. Vincent Hospital | Green Bay, Wisconsin 54301-3526 |
Providence Holy Cross Cancer Center | Mission Hills, California 91346-9600 |
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Tampa, Florida 33612 |
Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
Wendt Regional Cancer Center at Finley Hospital | Dubuque, Iowa 52001 |
Tulane Cancer Center | New Orleans, Louisiana 70112 |
Regional Cancer Center at Singing River Hospital | Pascagoula, Mississippi 39581 |
All Saints Cancer Center at All Saints Healthcare | Racine, Wisconsin 53405 |
John B. Amos Cancer Center | Columbus, Georgia 31904 |
Leo W. Jenkins Cancer Center at ECU Medical School | Greenville, North Carolina 27834 |
Guthrie Cancer Center at Guthrie Clinic Sayre | Sayre, Pennsylvania 18840 |
York Cancer Center at Apple Hill Medical Center | York, Pennsylvania 17405 |
St. Joseph Cancer Center | Bellingham, Washington 98225 |
Schiffler Cancer Center at Wheeling Hospital | Wheeling, West Virginia 26003 |
University of Minnesota Medical Center & Children's Hospital - Fairview | Minneapolis, Minnesota 55455 |
Methodist Cancer Center at Methodist Hospital - Omaha | Omaha, Nebraska 68114 |
Oregon Health & Science University Cancer Institute | Portland, Oregon 97239-3098 |
Arizona Oncology Services Foundation | Phoenix, Arizona 85013 |
Radiological Associates of Sacramento Medical Group, Incorporated | Sacramento, California 95815 |
Hospital of Saint Raphael | New Haven, Connecticut 06511 |
Good Samaritan Cancer Center at Good Samaritan Hospital | Kearney, Nebraska 68848-1990 |
Long Island College Hospital | Brooklyn, New York 11201 |
Mercy Cancer Institute at Mercy Hospital | Pittsburgh, Pennsylvania 15219 |
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Dana-Farber/Brigham and Women's Cancer Center | Boston, Massachusetts 02115 |
Cancer Institute at St. John's Hospital | Springfield, Illinois 62701 |
Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
Solano Radiation Oncology Center | Vacaville, California 95687 |
Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center | Boca Raton, Florida 33486 |
Mercy General Hospital | Sacramento, California 95819 |
Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea | Scottsdale, Arizona 85260 |
Virginia G. Piper Cancer Center at Scottsdale Healthcare - Osborn | Scottsdale, Arizona 85251 |
Cancer Center of Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |
Dale and Frances Hughes Cancer Center at Pocono Medical Center | East Stroudsburg, Pennsylvania 18301 |
J. Phillip Citta Regional Cancer Center at Community Medical Center | Toms River, New Jersey 08755 |
Cancer Institute of New Jersey at Cooper University Hospital - Camden | Camden, New Jersey 08103 |
Hudner Oncology Center at Saint Anne's Hospital - Fall River | Fall River, Massachusetts 02721 |
Auburn Radiation Oncology | Auburn, California 95603 |
Radiation Oncology Centers - Cameron Park | Cameron Park, California 95682 |
Radiation Oncology Center - Roseville | Roseville, California 95661 |
Mercy Cancer Center at Mercy San Juan Medical Center | Carmichael, California 95608 |
M.D. Anderson Cancer Center Orlando | Orlando, Florida 32806 |
John D. Cronin Cancer Center | Lexington, Kentucky 40504 |