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

Status: Active, not recruiting
Location: See all (185) locations...
Intervention Type: Radiation, Biological, Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 120
Healthy Volunteers: No
View:

• Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls).

• Patients must be positive for p16, determined by central review prior to randomization.

• Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations. Tonsillectomy or local excision of the primary without removal of nodal disease is permitted, as is excision removing gross nodal disease but with intact primary site. Limited neck dissections retrieving ≤ 4 nodes are permitted and considered as non-therapeutic nodal excisions. Fine needle aspirations of the neck are insufficient due to limited tissue for retrospective central review. Biopsy specimens from the primary or nodes measuring at least 3-5 mm are required.

• Clinical stage T1-2, N2a-N3 or T3-4, any N (AJCC, 7th ed.; see Appendix III), including no distant metastases, based upon the following minimum diagnostic workup:

• General history and physical examination by a radiation oncologist and medical oncologist within 8 weeks prior to registration;

• Examination by an ear, nose, and throat (ENT) or head and neck surgeon, including laryngopharyngoscopy (mirror and/or fiberoptic and/or direct procedure) within 8 weeks prior to registration;

• One of the following combinations of imaging is required within 8 weeks prior to registration:

• A computerized tomography (CT) scan of the neck (with contrast) and a chest CT scan (with or without contrast);

• or a magnetic resonance imaging (MRI) scan of the neck (with contrast) and a chest CT scan (with or without contrast);

• or a CT scan of neck (with contrast) and a positron emission tomography (PET)/CT of neck and chest (with or without contrast);

• or an MRI of the neck (with contrast) and a PET/CT of neck and chest (with or without contrast).

• Note: A CT scan of neck and/or a PET/CT performed for radiation planning and read by a radiologist may serve as both staging and planning tools.

• Zubrod Performance Status 0-1 within 2 weeks prior to registration

• Age ≥ 18;

• Complete blood count (CBC)/differential obtained within 2 weeks prior to registration on study, with adequate bone marrow function, defined as follows:

• Absolute neutrophil count (ANC) > 1,500 cells/mm3;

• Platelets > 100,000 cells/mm3;

• Hemoglobin (Hgb) > 8.0 g/dl; Note: The use of transfusion or other intervention to achieve Hgb > 8.0 g/dl is acceptable.

• Adequate hepatic function, defined as follows:

• Bilirubin < 2 mg/dl within 2 weeks prior to registration;

• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x the upper limit of normal within 2 weeks prior to registration;

• Adequate renal function, defined as follows:

• • Serum creatinine < 1.5 mg/dl within 2 weeks prior to registration or creatinine clearance (CCr) ≥ 50 ml/min within 2 weeks prior to registration determined by 24-hour collection or estimated by Cockcroft-Gault formula:

• CCr male = [(140 - age) x (wt in kg)] [(Serum Cr mg/dl) x (72)] CCr female = 0.85 x (CCr male)

• Patients must provide their smoking history (for stratification) via the computer-assisted self interview (CASI) head and neck risk factor survey tool.

• Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential;

• Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study and until at least 60 days following the last study treatment.

• Patients who are human immunodeficiency virus (HIV) positive but have no prior acquired immune deficiency syndrome (AIDS) -defining illness and have CD4 cells of at least 350/mm3 are eligible. Patient HIV status must be known prior to registration. Patients must not be sero-positive for Hepatitis B (Hepatitis B surface antigen positive or anti-hepatitis B core antigen positive) or sero-positive for Hepatitis C (anti-Hepatitis C antibody positive). However, patients who are immune to hepatitis B (anti-Hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B). HIV-positive patients must not have multi-drug resistant HIV infection or other concurrent AIDS-defining conditions.

• Patient must provide study specific informed consent prior to study entry, including consent for mandatory submission of tissue for required, central p16 review and consent to participate in the computer-assisted self interview (CASI) survey questions regarding smoking history.

Locations
United States
Alaska
Providence Cancer Center
Anchorage
California
Auburn Radiation Oncology
Auburn
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
Burbank
Radiation Oncology Centers - Cameron Park
Cameron Park
Mercy Cancer Center at Mercy San Juan Medical Center
Carmichael
Enloe Cancer Center at Enloe Medical Center
Chico
City of Hope Comprehensive Cancer Center
Duarte
Rebecca and John Moores UCSD Cancer Center
La Jolla
Kaiser Permanente - Division of Research - Oakland
Oakland
Rohnert Park Cancer Center
Rohnert Park
Radiation Oncology Center - Roseville
Roseville
Mercy General Hospital
Sacramento
Radiological Associates of Sacramento Medical Group, Incorporated
Sacramento
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco
Santa Clara
Kaiser Permanente Medical Center - South San Francisco
South San Francisco
Solano Radiation Oncology Center
Vacaville
Colorado
Rocky Mountain Cancer Centers - Aurora
Aurora
Boulder Community Hospital
Boulder
Penrose Cancer Center at Penrose Hospital
Colorado Springs
Porter Adventist Hospital
Denver
Swedish Medical Center
Englewood
McKee Medical Center
Loveland
North Suburban Medical Center
Thornton
Connecticut
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
New Britain
Delaware
CCOP - Christiana Care Health Services
Newark
Florida
North Broward Medical Center
Deerfield Beach
Baptist Cancer Institute - Jacksonville
Jacksonville
Baptist Medical Center South
Jacksonville
Integrated Community Oncology Network at Southside Cancer Center
Jacksonville
Integrated Community Oncology Network
Jacksonville Beach
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami
Integrated Community Oncology Network - Orange Park
Orange Park
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando
M.D. Anderson Cancer Center at Orlando
Orlando
Florida Cancer Center - Palatka
Palatka
Sacred Heart Cancer Center at Sacred Heart Hospital
Pensacola
Flagler Cancer Center
Saint Augustine
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa
Georgia
Georgia Cancer Center for Excellence at Grady Memorial Hospital
Atlanta
Winship Cancer Institute of Emory University
Atlanta
Northeast Georgia Medical Center
Gainesville
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
Savannah
Iowa
McFarland Clinic, PC
Ames
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines
Siouxland Hematology-Oncology Associates, LLP
Sioux City
Illinois
Northwest Community Hospital
Arlington Heights
Creticos Cancer Center at Advocate Illinois Masonic Medical Center
Chicago
John H. Stroger, Jr. Hospital of Cook County
Chicago
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago
University of Chicago Cancer Research Center
Chicago
Decatur Memorial Hospital Cancer Care Institute
Decatur
Evanston Hospital
Evanston
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood
Cancer Institute at St. John's Hospital
Springfield
Regional Cancer Center at Memorial Medical Center
Springfield
Indiana
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove
Elkhart General Hospital
Elkhart
Parkview Regional Cancer Center at Parkview Health
Fort Wayne
Center for Cancer Care at Goshen General Hospital
Goshen
Community Regional Cancer Care at Community Hospital East
Indianapolis
Community Regional Cancer Care at Community Hospital North
Indianapolis
Michiana Hematology-Oncology, PC - South Bend
Mishawaka
Cancer Center at Ball Memorial Hospital
Muncie
Memorial Hospital of South Bend
South Bend
Kansas
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City
Kansas City Cancer Centers - Southwest
Overland Park
CCOP - Kansas City
Prairie Village
Kentucky
Lucille P. Markey Cancer Center at University of Kentucky
Lexington
James Graham Brown Cancer Center at University of Louisville
Louisville
Louisiana
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge
CCOP - Ochsner
New Orleans
Massachusetts
Lahey Clinic Medical Center - Burlington
Burlington
NSMC Cancer Center - Peabody
Danvers
Hudner Oncology Center at Saint Anne's Hospital - Fall River
Fall River
Maryland
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore
St. Agnes Hospital Cancer Center
Baltimore
Maine
Maine Center for Cancer Medicine and Blood Disorders - Scarborough
Scarborough
Michigan
Saint Joseph Mercy Cancer Center
Ann Arbor
Battle Creek Health System Cancer Care Center
Battle Creek
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit
Genesys Hurley Cancer Institute
Flint
Butterworth Hospital at Spectrum Health
Grand Rapids
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids
Minnesota
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids
Fairview Southdale Hospital
Edina
Mercy and Unity Cancer Center at Unity Hospital
Fridley
Park Nicollet Cancer Center
Saint Louis Park
Regions Hospital Cancer Care Center
Saint Paul
Missouri
Cancer Institute of Cape Girardeau, LLC
Cape Girardeau
Kansas City Cancer Centers - North
Kansas City
Kansas City Cancer Centers - South
Kansas City
Barnes-Jewish West County Hospital
Saint Louis
CCOP - St. Louis-Cape Girardeau
Saint Louis
David C. Pratt Cancer Center at St. John's Mercy
Saint Louis
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis
Hulston Cancer Center at Cox Medical Center South
Springfield
Mississippi
Regional Cancer Center at Singing River Hospital
Pascagoula
Montana
Billings Clinic - Downtown
Billings
North Carolina
Mission Hospitals - Memorial Campus
Asheville
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
Greensboro
Kinston Medical Specialists
Kinston
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
Pinehurst
Nebraska
Methodist Estabrook Cancer Center
Omaha
Nebraska Medical Center
Omaha
New Hampshire
Payson Center for Cancer Care at Concord Hospital
Concord
Seacoast Cancer Center at Wentworth - Douglass Hospital
Dover
Kingsbury Center for Cancer Care at Cheshire Medical Center
Keene
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon
New Jersey
Monmouth Medical Center
Long Branch
Frederick R. and Betty M. Smith Cancer Treatment Center
Sparta
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees
New Mexico
University of New Mexico Cancer Center
Albuquerque
Nevada
Renown Institute for Cancer at Renown Regional Medical Center
Reno
New York
Lourdes Regional Cancer Center
Binghamton
Highland Hospital of Rochester
Rochester
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester
Ohio
Summa Center for Cancer Care at Akron City Hospital
Akron
Barberton Citizens Hospital
Barberton
Charles M. Barrett Cancer Center at University Hospital
Cincinnati
Case Comprehensive Cancer Center
Cleveland
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland
Cleveland Clinic Taussig Cancer Center
Cleveland
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus
Northwest Ohio Oncology Center
Maumee
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights
Lake/University Ireland Cancer Center
Mentor
Southwest General Health Center
Middleburg Heights
St. Charles Mercy Hospital
Oregon
Flower Hospital Cancer Center
Sylvania
St. Anne Mercy Hospital
Toledo
Precision Radiotherapy at University Pointe
West Chester
UHHS Westlake Medical Center
Westlake
Cancer Treatment Center
Wooster
Oklahoma
Oklahoma University Cancer Institute
Oklahoma City
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa
Oregon
Clackamas Radiation Oncology Center
Clackamas
Dubs Cancer Center at Rogue Valley Medical Center
Medford
Providence Cancer Center at PMCC
Medford
Knight Cancer Institute at Oregon Health and Science University
Portland
Providence Cancer Center at Providence Portland Medical Center
Portland
Providence St. Vincent Medical Center
Portland
Pennsylvania
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington
Dale and Frances Hughes Cancer Center at Pocono Medical Center
East Stroudsburg
Adams Cancer Center
Gettysburg
Cherry Tree Cancer Center
Hanover
St. Mary Regional Cancer Center
Langhorne
Fox Chase Cancer Center - Philadelphia
Philadelphia
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading
York Cancer Center at Apple Hill Medical Center
York
South Carolina
Hollings Cancer Center at Medical University of South Carolina
Charleston
Cancer Centers of the Carolinas - Faris Road
Greenville
CCOP - Greenville
Greenville
Cancer Centers of the Carolinas - Spartanburg
Spartanburg
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg
South Dakota
Rapid City Regional Hospital
Rapid City
Tennessee
Vanderbilt-Ingram Cancer Center
Nashville
Texas
University of Texas Medical Branch
Galveston
M. D. Anderson Cancer Center at University of Texas
Houston
Utah
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Murray
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
Ogden
Utah Valley Regional Medical Center - Provo
Provo
Huntsman Cancer Institute at University of Utah
Salt Lake City
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City
Virginia
Sentara Cancer Institute at Sentara Norfolk General Hospital
Norfolk
Coastal Cancer Center at Sentara Virginia Beach General Hospital
Virginia Beach
Washington
St. Joseph Cancer Center
Bellingham
CCOP - Virginia Mason Research Center
Seattle
Northwest Cancer Specialists at Vancouver Cancer Center
Vancouver
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima
Wisconsin
Theda Care Cancer Institute
Appleton
St. Mary's Hospital Medical Center - Green Bay
Green Bay
St. Vincent Hospital Regional Cancer Center
Green Bay
Gundersen Lutheran Center for Cancer and Blood
La Crosse
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette
Medical College of Wisconsin Cancer Center
Milwaukee
Veterans Affairs Medical Center - Milwaukee
Milwaukee
University of Wisconcin Cancer Center at Aspirus Wausau Hospital
Wausau
West Virginia
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
Huntington
Schiffler Cancer Center at Wheeling Hospital
Wheeling
Other Locations
Canada
McGill Cancer Centre at McGill University
Montreal
CancerCare Manitoba
Winnipeg
Time Frame
Start Date: June 2011
Estimated Completion Date: July 12, 2018
Participants
Target number of participants: 987
Treatments
Active Comparator: IMRT + Cisplatin
Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin
Active Comparator: IMRT + Cetuximab
Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab
Authors
Maura Gillison, Andy M. Trotti
Sponsors
Leads: Radiation Therapy Oncology Group
Collaborators: NRG Oncology, National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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