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COMPLETED
NCT01302834
PHASE3

Radiation Therapy With Cisplatin or Cetuximab in Treating Patients With Oropharyngeal Cancer

Sponsor: Radiation Therapy Oncology Group

View on ClinicalTrials.gov

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether radiation therapy is more effective with cisplatin or cetuximab in treating oropharyngeal cancer. PURPOSE: This phase III trial is studying radiation therapy with cisplatin or cetuximab to see how well it works in treating patients with oropharyngeal cancer.

Official title: Phase III Trial of Radiotherapy Plus Cetuximab Versus Chemoradiotherapy in HPV-Associated Oropharynx Cancer

Key Details

Gender

All

Age Range

18 Years - 120 Years

Study Type

INTERVENTIONAL

Enrollment

987

Start Date

2011-06

Completion Date

2025-09-04

Last Updated

2026-07-20

Healthy Volunteers

No

Interventions

BIOLOGICAL

cetuximab

400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks

DRUG

cisplatin

100 mg/m2 IV on days 1 and 22 of IMRT

RADIATION

IMRT

35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.

Locations (185)

Providence Cancer Center

Anchorage, Alaska, United States

Auburn Radiation Oncology

Auburn, California, United States

Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center

Burbank, California, United States

Radiation Oncology Centers - Cameron Park

Cameron Park, California, United States

Mercy Cancer Center at Mercy San Juan Medical Center

Carmichael, California, United States

Enloe Cancer Center at Enloe Medical Center

Chico, California, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, United States

Kaiser Permanente - Division of Research - Oakland

Oakland, California, United States

Rohnert Park Cancer Center

Rohnert Park, California, United States

Radiation Oncology Center - Roseville

Roseville, California, United States

Radiological Associates of Sacramento Medical Group, Incorporated

Sacramento, California, United States

Mercy General Hospital

Sacramento, California, United States

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Santa Clara, California, United States

Kaiser Permanente Medical Center - South San Francisco

South San Francisco, California, United States

Solano Radiation Oncology Center

Vacaville, California, United States

Rocky Mountain Cancer Centers - Aurora

Aurora, Colorado, United States

Boulder Community Hospital

Boulder, Colorado, United States

Penrose Cancer Center at Penrose Hospital

Colorado Springs, Colorado, United States

Porter Adventist Hospital

Denver, Colorado, United States

Swedish Medical Center

Englewood, Colorado, United States

McKee Medical Center

Loveland, Colorado, United States

North Suburban Medical Center

Thornton, Colorado, United States

George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus

New Britain, Connecticut, United States

CCOP - Christiana Care Health Services

Newark, Delaware, United States

North Broward Medical Center

Dearfield Beach, Florida, United States

Baptist Cancer Institute - Jacksonville

Jacksonville, Florida, United States

Integrated Community Oncology Network at Southside Cancer Center

Jacksonville, Florida, United States

Integrated Community Oncology Network

Jacksonville Beach, Florida, United States

Baptist Medical Center South

Jascksonville, Florida, United States

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, United States

Integrated Community Oncology Network - Orange Park

Orange Park, Florida, United States

Florida Hospital Cancer Institute at Florida Hospital Orlando

Orlando, Florida, United States

M.D. Anderson Cancer Center at Orlando

Orlando, Florida, United States

Florida Cancer Center - Palatka

Palatka, Florida, United States

Sacred Heart Cancer Center at Sacred Heart Hospital

Pensacola, Florida, United States

Flagler Cancer Center

Saint Augustine, Florida, United States

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Tampa, Florida, United States

Georgia Cancer Center for Excellence at Grady Memorial Hospital

Atlanta, Georgia, United States

Winship Cancer Institute of Emory University

Atlanta, Georgia, United States

Northeast Georgia Medical Center

Gainesville, Georgia, United States

Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

Savannah, Georgia, United States

Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler

Savannah, Georgia, United States

Northwest Community Hospital

Arlington Heights, Illinois, United States

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, United States

John H. Stroger, Jr. Hospital of Cook County

Chicago, Illinois, United States

University of Chicago Cancer Research Center

Chicago, Illinois, United States

Creticos Cancer Center at Advocate Illinois Masonic Medical Center

Chicago, Illinois, United States

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, United States

Evanston Hospital

Evanston, Illinois, United States

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, United States

Cancer Institute at St. John's Hospital

Springfield, Illinois, United States

Regional Cancer Center at Memorial Medical Center

Springfield, Illinois, United States

St. Francis Hospital and Health Centers - Beech Grove Campus

Beech Grove, Indiana, United States

Elkhart General Hospital

Elkhart, Indiana, United States

Parkview Regional Cancer Center at Parkview Health

Fort Wayne, Indiana, United States

Center for Cancer Care at Goshen General Hospital

Goshen, Indiana, United States

Community Regional Cancer Care at Community Hospital East

Indianapolis, Indiana, United States

Community Regional Cancer Care at Community Hospital North

Indianapolis, Indiana, United States

Michiana Hematology-Oncology, PC - South Bend

Mishawaka, Indiana, United States

Cancer Center at Ball Memorial Hospital

Muncie, Indiana, United States

Memorial Hospital of South Bend

South Bend, Indiana, United States

McFarland Clinic, PC

Ames, Iowa, United States

John Stoddard Cancer Center at Iowa Methodist Medical Center

Des Moines, Iowa, United States

Siouxland Hematology-Oncology Associates, LLP

Sioux City, Iowa, United States

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

Kansas City, Kansas, United States

Kansas City Cancer Centers - Southwest

Overland Park, Kansas, United States

CCOP - Kansas City

Prairie Village, Kansas, United States

Lucille P. Markey Cancer Center at University of Kentucky

Lexington, Kentucky, United States

James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, United States

Mary Bird Perkins Cancer Center - Baton Rouge

Baton Rouge, Louisiana, United States

CCOP - Ochsner

New Orleans, Louisiana, United States

Maine Center for Cancer Medicine and Blood Disorders - Scarborough

Scarborough, Maine, United States

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, United States

St. Agnes Hospital Cancer Center

Baltimore, Maryland, United States

Lahey Clinic Medical Center - Burlington

Burlington, Massachusetts, United States

NSMC Cancer Center - Peabody

Danvers, Massachusetts, United States

Hudner Oncology Center at Saint Anne's Hospital - Fall River

Fall River, Massachusetts, United States

Saint Joseph Mercy Cancer Center

Ann Arbor, Michigan, United States

Battle Creek Health System Cancer Care Center

Battle Creek, Michigan, United States

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, United States

Genesys Hurley Cancer Institute

Flint, Michigan, United States

Butterworth Hospital at Spectrum Health

Grand Rapids, Michigan, United States

Lacks Cancer Center at Saint Mary's Health Care

Grand Rapids, Michigan, United States

Mercy and Unity Cancer Center at Mercy Hospital

Coon Rapids, Minnesota, United States

Fairview Southdale Hospital

Edina, Minnesota, United States

Mercy and Unity Cancer Center at Unity Hospital

Fridley, Minnesota, United States

Park Nicollet Cancer Center

Saint Louis Park, Minnesota, United States

Regions Hospital Cancer Care Center

Saint Paul, Minnesota, United States

Regional Cancer Center at Singing River Hospital

Pascagoula, Mississippi, United States

Cancer Institute of Cape Girardeau, LLC

Cape Girardeau, Missouri, United States

Kansas City Cancer Centers - South

Kansas City, Missouri, United States

Kansas City Cancer Centers - North

Kansas City, Missouri, United States

Hulston Cancer Center at Cox Medical Center South

Springfield, Missouri, United States

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, United States

Barnes-Jewish West County Hospital

St Louis, Missouri, United States

CCOP - St. Louis-Cape Girardeau

St Louis, Missouri, United States

David C. Pratt Cancer Center at St. John's Mercy

St Louis, Missouri, United States

Billings Clinic - Downtown

Billings, Montana, United States

Methodist Estabrook Cancer Center

Omaha, Nebraska, United States

Nebraska Medical Center

Omaha, Nebraska, United States

Renown Institute for Cancer at Renown Regional Medical Center

Reno, Nevada, United States

Payson Center for Cancer Care at Concord Hospital

Concord, New Hampshire, United States

Seacoast Cancer Center at Wentworth - Douglass Hospital

Dover, New Hampshire, United States

Kingsbury Center for Cancer Care at Cheshire Medical Center

Keene, New Hampshire, United States

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Monmouth Medical Center

Long Branch, New Jersey, United States

Frederick R. and Betty M. Smith Cancer Treatment Center

Sparta, New Jersey, United States

Cancer Institute of New Jersey at Cooper - Voorhees

Voorhees Township, New Jersey, United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Lourdes Regional Cancer Center

Binghamton, New York, United States

Highland Hospital of Rochester

Rochester, New York, United States

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, United States

Mission Hospitals - Memorial Campus

Asheville, North Carolina, United States

Blumenthal Cancer Center at Carolinas Medical Center

Charlotte, North Carolina, United States

Moses Cone Regional Cancer Center at Wesley Long Community Hospital

Greensboro, North Carolina, United States

Kinston Medical Specialists

Kinston, North Carolina, United States

FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center

Pinehurst, North Carolina, United States

Summa Center for Cancer Care at Akron City Hospital

Akron, Ohio, United States

Barberton Citizens Hospital

Barberton, Ohio, United States

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, United States

Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Cleveland Clinic Cancer Center at Fairview Hospital

Cleveland, Ohio, United States

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Northwest Ohio Oncology Center

Maumee, Ohio, United States

Hillcrest Cancer Center at Hillcrest Hospital

Mayfield Heights, Ohio, United States

Lake/University Ireland Cancer Center

Mentor, Ohio, United States

Southwest General Health Center

Middleburg Heights, Ohio, United States

St. Charles Mercy Hospital

Oregon, Ohio, United States

Flower Hospital Cancer Center

Sylvania, Ohio, United States

St. Anne Mercy Hospital

Toledo, Ohio, United States

Precision Radiotherapy at University Pointe

West Chester, Ohio, United States

UHHS Westlake Medical Center

Westlake, Ohio, United States

Cancer Treatment Center

Wooster, Ohio, United States

Oklahoma University Cancer Institute

Oklahoma City, Oklahoma, United States

Natalie Warren Bryant Cancer Center at St. Francis Hospital

Tulsa, Oklahoma, United States

Clackamas Radiation Oncology Center

Clackamas, Oregon, United States

Dubs Cancer Center at Rogue Valley Medical Center

Medford, Oregon, United States

Providence Cancer Center at PMCC

Medford, Oregon, United States

Providence Cancer Center at Providence Portland Medical Center

Portland, Oregon, United States

Providence St. Vincent Medical Center

Portland, Oregon, United States

Knight Cancer Institute at Oregon Health and Science University

Portland, Oregon, United States

Rosenfeld Cancer Center at Abington Memorial Hospital

Abington, Pennsylvania, United States

Dale and Frances Hughes Cancer Center at Pocono Medical Center

East Stroudsburg, Pennsylvania, United States

Adams Cancer Center

Gettysburg, Pennsylvania, United States

Cherry Tree Cancer Center

Hanover, Pennsylvania, United States

St. Mary Regional Cancer Center

Langhorne, Pennsylvania, United States

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, United States

McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

Reading, Pennsylvania, United States

York Cancer Center at Apple Hill Medical Center

York, Pennsylvania, United States

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, United States

Cancer Centers of the Carolinas - Faris Road

Greenville, South Carolina, United States

CCOP - Greenville

Greenville, South Carolina, United States

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, United States

Cancer Centers of the Carolinas - Spartanburg

Spartanburg, South Carolina, United States

Rapid City Regional Hospital

Rapid City, South Dakota, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

University of Texas Medical Branch

Galveston, Texas, United States

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, United States

Jon and Karen Huntsman Cancer Center at Intermountain Medical Center

Murray, Utah, United States

Val and Ann Browning Cancer Center at McKay-Dee Hospital Center

Ogden, Utah, United States

Utah Valley Regional Medical Center - Provo

Provo, Utah, United States

Utah Cancer Specialists at UCS Cancer Center

Salt Lake City, Utah, United States

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, United States

Sentara Cancer Institute at Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Coastal Cancer Center at Sentara Virginia Beach General Hospital

Virginia Beach, Virginia, United States

St. Joseph Cancer Center

Bellingham, Washington, United States

CCOP - Virginia Mason Research Center

Seattle, Washington, United States

Northwest Cancer Specialists at Vancouver Cancer Center

Vancouver, Washington, United States

North Star Lodge Cancer Center at Yakima Valley Memorial Hospital

Yakima, Washington, United States

Edwards Comprehensive Cancer Center at Cabell Huntington Hospital

Huntington, West Virginia, United States

Schiffler Cancer Center at Wheeling Hospital

Wheeling, West Virginia, United States

Theda Care Cancer Institute

Appleton, Wisconsin, United States

St. Mary's Hospital Medical Center - Green Bay

Green Bay, Wisconsin, United States

St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, United States

Gundersen Lutheran Center for Cancer and Blood

La Crosse, Wisconsin, United States

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Madison, Wisconsin, United States

Bay Area Cancer Care Center at Bay Area Medical Center

Marinette, Wisconsin, United States

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, United States

Veterans Affairs Medical Center - Milwaukee

Milwaukee, Wisconsin, United States

University of Wisconcin Cancer Center at Aspirus Wausau Hospital

Wausau, Wisconsin, United States

CancerCare Manitoba

Winnipeg, Manitoba, Canada

McGill Cancer Centre at McGill University

Montreal, Quebec, Canada