Phase III Trial of Radiotherapy Plus Cetuximab Versus Chemoradiotherapy in HPV-Associated Oropharynx Cancer
OBJECTIVES:
Primary
- To determine whether substitution of cisplatin with cetuximab will result in comparable
5-year overall survival.
Secondary
- To monitor and compare progression-free survival for "safety".
- To compare patterns of failure (locoregional vs distant).
- To compare acute toxicity profiles (and overall toxicity burden).
- To compare overall quality of life (QOL) short-term (< 6 months) and long-term (2
years).
- To compare QOL Swallowing Domains short-term and long-term.
- To compare clinician-reported versus patient-reported CTCAE toxicity events.
- To explore differences in the cost effectiveness of cetuximab as compared to cisplatin.
- To explore differences in work status and time to return to work.
- To compare patient-reported changes in hearing.
- To compare CTCAE v. 4 late toxicity at 1, 2, and 5 years.
- To evaluate the effect of tobacco exposure (and other exposures) as measured by
standardized computer-assisted self interview (CASI) on overall survival and
progression-free survival.
- To pilot CASI collection of patient reported outcomes in a cooperative group setting.
- To determine whether specific molecular profiles are associated with overall or
progression-free survival.
- To investigate associations between changes in serum biomarkers or HPV-specific
cellular immune responses measured at baseline and three months with overall or
progression-free survival.
OUTLINE: This is a multicenter study. Patients are stratified according to T stage (T1-2 vs
T 3-4), N stage (N0-2a vs N2b-3), Zubrod performance status (0 vs 1), and smoking history (≤
10 pack-years vs > 10 pack-years). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo image-guided intensity-modulated radiation therapy (IMRT) once
daily on days 1-4 and twice daily on day 5 weekly for 6 weeks. Patients also receive
high-dose cisplatin IV over 1-2 hours on days 1 and 22.
- Arm II: Beginning 1 week prior to IMRT, patients receive cetuximab IV over 2 hours.
Patients then receive cetuximab IV over 1 hour once weekly for 7 weeks. Patients
undergo IMRT as in arm I.
Tumor tissue and blood samples are collected at baseline and may also be collected at 3- and
6-month follow-up visits for correlative studies.
Patients may complete quality-of-life questionnaires and risk factors for head and neck
cancer surveys at baseline, periodically during study, and at follow-up for 1 year.
After completion of study therapy, patients are followed up at 1-3 months, every 3 months
for 2 years, every 6 months for 3 years, and then annually thereafter.
Interventional
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
5-year overall survival
No
Andy M. Trotti, MD
Principal Investigator
H. Lee Moffitt Cancer Center and Research Institute
Unspecified
CDR0000695731
NCT01302834
June 2011
Name | Location |
---|---|
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
Boulder Community Hospital | Boulder, Colorado 80301-9019 |
Penrose Cancer Center at Penrose Hospital | Colorado Springs, Colorado 80933 |
Porter Adventist Hospital | Denver, Colorado 80210 |
Swedish Medical Center | Englewood, Colorado 80110 |
North Suburban Medical Center | Thornton, Colorado 80229 |
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus | New Britain, Connecticut 06050 |
Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa 51101 |
Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
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 |
Park Nicollet Cancer Center | St. Louis Park, Minnesota 55416 |
Regions Hospital Cancer Care Center | St. Paul, Minnesota 55101 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa, Oklahoma 74136 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison, Wisconsin 53792-6164 |
Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
CCOP - Ochsner | New Orleans, Louisiana 70121 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
Northwest Community Hospital | Arlington Heights, Illinois 60005 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
CCOP - Greenville | Greenville, South Carolina 29615 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
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 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
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 |
Monmouth Medical Center | Long Branch, New Jersey 07740-6395 |
Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
James Graham Brown Cancer Center at University of Louisville | Louisville, Kentucky 40202 |
Maine Center for Cancer Medicine and Blood Disorders - Scarborough | Scarborough, Maine 04074 |
Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
Lake/University Ireland Cancer Center | Mentor, Ohio 44060 |
Florida Hospital Cancer Institute at Florida Hospital Orlando | Orlando, Florida 32803-1273 |
Sacred Heart Cancer Center at Sacred Heart Hospital | Pensacola, Florida 32504 |
Winship Cancer Institute of Emory University | Atlanta, Georgia 30322 |
Mission Hospitals - Memorial Campus | Asheville, North Carolina 28801 |
Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital | Huntington, West Virginia 25701 |
St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
Lahey Clinic Medical Center - Burlington | Burlington, Massachusetts 01805 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
St. Mary's Hospital Medical Center - Green Bay | Green Bay, Wisconsin 54303 |
Bay Area Cancer Care Center at Bay Area Medical Center | Marinette, Wisconsin 54143 |
Lourdes Regional Cancer Center | Binghamton, New York 13905 |
McKee Medical Center | Loveland, Colorado 80539 |
Baptist Cancer Institute - Jacksonville | Jacksonville, Florida 32207 |
Battle Creek Health System Cancer Care Center | Battle Creek, Michigan 49017 |
David C. Pratt Cancer Center at St. John's Mercy | St. Louis, Missouri 63141 |
Utah Cancer Specialists at UCS Cancer Center | Salt Lake City, Utah 84106 |
Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco, California 94115 |
M.D. Anderson Cancer Center at Orlando | Orlando, Florida 32806 |
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia 31403-3089 |
Lucille P. Markey Cancer Center at University of Kentucky | Lexington, Kentucky 40536-0093 |
Butterworth Hospital at Spectrum Health | Grand Rapids, Michigan 49503-2560 |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
Knight Cancer Institute at Oregon Health and Science University | Portland, Oregon 97239-3098 |
M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
Gundersen Lutheran Center for Cancer and Blood | La Crosse, Wisconsin 54601 |
Methodist Estabrook Cancer Center | Omaha, Nebraska 68114-4199 |
Huntsman Cancer Institute at University of Utah | Salt Lake City, Utah 84112 |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois 62526 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
Cleveland Clinic Cancer Center at Fairview Hospital | Cleveland, Ohio 44111 |
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 |
Kaiser Permanente Medical Center - South San Francisco | South San Francisco, California 94080 |
St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove, Indiana 46107 |
Mary Bird Perkins Cancer Center - Baton Rouge | Baton Rouge, Louisiana 70809 |
Kingsbury Center for Cancer Care at Cheshire Medical Center | Keene, New Hampshire 03431 |
Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
Highland Hospital of Rochester | Rochester, New York 14620 |
Northwest Ohio Oncology Center | Maumee, Ohio 43537 |
St. Charles Mercy Hospital | Oregon, Ohio 43616 |
Providence Cancer Center at Providence Portland Medical Center | Portland, Oregon 97213-2967 |
Providence St. Vincent Medical Center | Portland, Oregon 97225 |
St. Mary Regional Cancer Center | Langhorne, Pennsylvania 19047 |
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital | Yakima, Washington 98902 |
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Tampa, Florida 33612 |
Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
Creticos Cancer Center at Advocate Illinois Masonic Medical Center | Chicago, Illinois 60657 |
Cancer Center at Ball Memorial Hospital | Muncie, Indiana 47303 |
Regional Cancer Center at Singing River Hospital | Pascagoula, Mississippi 39581 |
Moses Cone Regional Cancer Center at Wesley Long Community Hospital | Greensboro, North Carolina 27401 |
Cancer Treatment Center | Wooster, Ohio 44691 |
University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami, Florida 33136 |
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler | Savannah, Georgia 31405 |
Evanston Hospital | Evanston, Illinois 60201-1781 |
Michiana Hematology-Oncology, PC - South Bend | Mishawaka, Indiana 46545-1470 |
McFarland Clinic, PC | Ames, Iowa 50010 |
Billings Clinic - Downtown | Billings, Montana 59107-7000 |
Frederick R. and Betty M. Smith Cancer Treatment Center | Sparta, New Jersey 07871 |
Summa Center for Cancer Care at Akron City Hospital | Akron, Ohio 44309-2090 |
Barberton Citizens Hospital | Barberton, Ohio 44203 |
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus, Ohio 43210-1240 |
Flower Hospital Cancer Center | Sylvania, Ohio 43560 |
St. Anne Mercy Hospital | Toledo, Ohio 43623 |
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
York Cancer Center at Apple Hill Medical Center | York, Pennsylvania 17405 |
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center | Murray, Utah 84157 |
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center | Ogden, Utah 84403 |
St. Joseph Cancer Center | Bellingham, Washington 98225 |
Schiffler Cancer Center at Wheeling Hospital | Wheeling, West Virginia 26003 |
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center | Pinehurst, North Carolina 28374 |
Regional Cancer Center at Memorial Medical Center | Springfield, Illinois 62781-0001 |
John H. Stroger, Jr. Hospital of Cook County | Chicago, Illinois 60612-9985 |
Enloe Cancer Center at Enloe Medical Center | Chico, California 95926 |
Radiological Associates of Sacramento Medical Group, Incorporated | Sacramento, California 95815 |
Parkview Regional Cancer Center at Parkview Health | Fort Wayne, Indiana 46805 |
Dubs Cancer Center at Rogue Valley Medical Center | Medford, Oregon 97504 |
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Theda Care Cancer Institute | Appleton, Wisconsin 54911 |
Kinston Medical Specialists | Kinston, North Carolina 28501 |
Cancer Centers of the Carolinas - Faris Road | Greenville, South Carolina 29605 |
Cancer Centers of the Carolinas - Spartanburg | Spartanburg, South Carolina 29307 |
Cancer Institute at St. John's Hospital | Springfield, Illinois 62701 |
Sentara Cancer Institute at Sentara Norfolk General Hospital | Norfolk, Virginia 23507 |
Providence Cancer Center | Anchorage, Alaska 99508 |
Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
University of Wisconcin Cancer Center at Aspirus Wausau Hospital | Wausau, Wisconsin 54401 |
Solano Radiation Oncology Center | Vacaville, California 95687 |
Integrated Community Oncology Network | Jacksonville Beach, Florida 32250 |
Baptist Medical Center South | Jascksonville, Florida 32258 |
Florida Cancer Center - Palatka | Palatka, Florida 32177 |
Flagler Cancer Center | Saint Augustine, Florida 32086 |
Mercy General Hospital | Sacramento, California 95819 |
Fountain Valley, California 92708 | |
Dale and Frances Hughes Cancer Center at Pocono Medical Center | East Stroudsburg, Pennsylvania 18301 |
Center for Cancer Care at Goshen General Hospital | Goshen, Indiana 46526 |
Cancer Institute of Cape Girardeau, LLC | Cape Girardeau, Missouri 63703 |
Providence Cancer Center at PMCC | Medford, Oregon 97504 |
Veterans Affairs Medical Center - Milwaukee | Milwaukee, Wisconsin 53295 |
Precision Radiotherapy at University Pointe | West Chester, Ohio 45069 |
Integrated Community Oncology Network - Orange Park | Orange Park, Florida 32073 |
Hudner Oncology Center at Saint Anne's Hospital - Fall River | Fall River, Massachusetts 02721 |
NSMC Cancer Center - Peabody | Peabody, Massachusetts 01960 |
Georgia Cancer Center for Excellence at Grady Memorial Hospital | Atlanta, Georgia 30303 |
Auburn Radiation Oncology | Auburn, California 95603 |
Radiation Oncology Centers - Cameron Park | Cameron Park, California 95682 |
Radiation Oncology Center - Roseville | Roseville, California 95661 |
Northwest Cancer Specialists at Vancouver Cancer Center | Vancouver, Washington 98684 |
Mercy Cancer Center at Mercy San Juan Medical Center | Carmichael, California 95608 |
Kaiser Permanente - Division of Research - Oakland | Oakland, California 94611 |
Rohnert Park Cancer Center | Rohnert Park, California 94928 |
CCOP - Kansas City | Prairie Village, Kansas 66208 |
St. Agnes Hospital Cancer Center | Baltimore, Maryland 21229 |
Barnes-Jewish West County Hospital | Saint Louis, Missouri 63141 |
Renown Institute for Cancer at Renown Regional Medical Center | Reno, Nevada 89502 |
Community Regional Cancer Care at Community Hospital North | Indianapolis, Indiana 46256 |
Community Regional Cancer Care at Community Hospital East | Indianapolis, Indiana 46219 |
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center | Burbank, California 91505 |
Integrated Community Oncology Network at Southside Cancer Center | Jacksonville, Florida 32207 |
Southwest General Health Center | Middleburgh Heights, Ohio 44130 |
UHHS Westlake Medical Center | Westlaker, Ohio 44145 |
Kansas City Cancer Centers - Southwest | Overland Park, Kansas 66210 |
Clackamas Radiation Oncology Center | Clackamas, Oregon 97015 |
North Broward Medical Center | Dearfield Beach, Florida 33064-3596 |
Kansas City Cancer Centers - North | Kansas City, Missouri 64154 |
Payson Center for Cancer Care at Concord Hospital | Concord, New Hampshire 03301 |
Seacoast Cancer Center at Wentworth - Douglass Hospital | Dover, New Hampshire 03820 |
Nebraska Medical Center | Omaha, Nebraska 68198 |
Rocky Mountain Cancer Centers - Aurora | Aurora, Colorado 80012 |
Kansas City Cancer Centers - South | Kansas City, Missouri 64131 |
Adams Cancer Center | Gettysburg, Pennsylvania 17325 |
Cherry Tree Cancer Center | Hanover, Pennsylvania 17331 |
Coastal Cancer Center at Sentara Virginia Beach General Hospital | Virginia Beach, Virginia 23454 |