Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With Stage III or Stage IV Head and Neck Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00265941
First received: December 14, 2005
Last updated: September 8, 2011
Last verified: September 2009
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. 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. Cisplatin may also make tumor cells more sensitive to radiation therapy. 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. Giving radiation therapy and cisplatin together with cetuximab may kill more tumor cells. It is not yet known whether radiation therapy and cisplatin are more effective with or without cetuximab in treating head and neck cancer.

PURPOSE: This randomized phase III trial is studying radiation therapy, cisplatin, and cetuximab to see how well they work compared to radiation therapy and cisplatin in treating patients with stage III or stage IV head and neck cancer.


Condition Intervention Phase
Head and Neck Cancer
Biological: cetuximab
Drug: cisplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase III Trial of Concurrent Accelerated Radiation and Cisplatin Versus Concurrent Accelerated Radiation, Cisplatin, and Cetuximab (C225) [Followed by Surgery for Selected Patients] for Stage III and IV Head and Neck Carcinomas

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Disease-free survival (DFS) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival (OS) [ Designated as safety issue: No ]
  • Local-regional control (LRC) [ Designated as safety issue: No ]
  • Mucositis toxicity ≥ grade 3 [ Designated as safety issue: Yes ]
  • Other toxicity ≥ grade 3 [ Designated as safety issue: Yes ]
  • Protocol treatment delivery [ Designated as safety issue: No ]
  • Death ≤ 30 days after discontinuation of protocol treatment [ Designated as safety issue: Yes ]
  • Quality of life as measured by Performance Status Scale for Head and Neck Cancer and the European Quality of Life questionnaire (EQ-5D) [ Designated as safety issue: No ]
  • Quality of life as measured by Functional Assessment of Cancer Therapy-General version [ Designated as safety issue: No ]
  • Correlation of expression of epidermal growth factor receptor or its down-stream molecules (e.g., MAPK, AKT, Stat-3, PKC) with DFS, OS, and LRC [ Designated as safety issue: No ]
  • Correlation of pre-treatment positron emission tomography (PET)/CT scan findings with DFS, OS, and LRC [ Designated as safety issue: No ]
  • Correlation of post-treatment PET/CT scan findings with pathologic nodal complete response and nodal relapse rate at 2 years in clinical N2-3 patients [ Designated as safety issue: No ]

Estimated Enrollment: 720
Study Start Date: November 2005
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I
Patients receive cisplatin IV over 1 hour on days 1 and 22 (weeks 1 and 4) during radiotherapy.
Drug: cisplatin
Given IV
Experimental: Arm II
Patients receive cetuximab IV over 1-2 hours once in weeks 0-7 and cisplatin as in arm I.
Biological: cetuximab
Given IV
Drug: cisplatin
Given IV

Detailed Description:

OBJECTIVES:

Primary

  • Evaluate whether the addition of cetuximab to a concurrent radiation-cisplatin regimen will improve disease-free survival in patients with stage III or IV squamous cell carcinoma of the oropharynx, hypopharynx, or larynx.

Secondary

  • Determine the impact of the addition of cetuximab to a concurrent radiation-cisplatin regimen on overall survival, local-regional control, acute and late toxic effects, quality of life, and health utilities in these patients.
  • Correlate the expression of EGFR and its down-stream molecules with outcome in patients participating in this component of the trial.
  • Correlate pre-treatment PET scan findings with disease-free survival, overall survival, and local-regional control in patients participating in this component of the trial.
  • Correlate post-treatment PET scan findings with nodal response and nodal relapse in patients participating in this component of the trial.

OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified according to primary site (larynx vs non-larynx), nodal stage (N0 vs N1, N2a, N2b vs N2c, N3), Zubrod performance status (0 vs 1), use of intensity modulated radiotherapy (IMRT) (no vs yes), and pre-treatment PET/CT scan (no vs yes). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo either 3D-conformal radiotherapy or IMRT once or twice a day, 5 or 6 days a week, for 6 weeks. Patients also receive cisplatin IV over 1 hour on days 1 and 22 (weeks 1 and 4) during radiotherapy.
  • Arm II: Patients receive cetuximab IV over 1-2 hours once in weeks 0-7. Beginning in week 1, patients also undergo radiotherapy and receive cisplatin as in arm I.

In both arms, patients with persistent nodal disease (any stage) (i.e., a residual palpable or radiographic abnormality) undergo neck dissection* approximately 9-10 weeks after completion of treatment.

NOTE: *A neck dissection is optional for patients with multiple lymph nodes or lymph nodes > 3 cm in diameter who achieve a complete clinical and radiographic response in the neck.

Quality of life is assessed at baseline, once during the last 2 weeks of treatment, at 3 and 12 months from the start of treatment, and then annually for 4 years.

After completion of study treatment, patients are followed periodically for 5 years and then annually thereafter.

PROJECTED ACCRUAL: Approximately 720 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven (from primary lesion and/or lymph nodes) squamous cell carcinoma of the oropharynx, hypopharynx, or larynx

    • Stage III or IV disease (T2, N2-3, M0; T3-4, any N, M0)

      • No distant metastases
    • The following primary tumor sites are excluded:

      • Oral cavity
      • Nasopharynx
      • Sinuses
      • Salivary glands

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1
  • Absolute neutrophil count (ANC) ≥ 1,800/mm^3
  • Platelets ≥ 100,000/mm^3
  • Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention to achieve Hgb ≥ 8.0 g/dL is acceptable)
  • Bilirubin ≤ 1.5 mg/dL (Gilbert's disease as the sole cause of elevated bilirubin may be allowed at the discretion of the principal investigator)
  • AST or ALT ≤ 2 times the upper limit of normal
  • Serum creatinine ≤ 1.5 mg/dL
  • Creatinine clearance ≥ 50 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • 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 (until at least 60 days following the last study treatment)
  • No prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
  • No unstable angina and/or congestive heart failure requiring hospitalization in past 6 months
  • Left ventricular ejection fraction ≥ 45%
  • No transmural myocardial infarction within the last 6 months
  • No acute bacterial or fungal infection requiring intravenous antibiotics
  • No chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy
  • No acquired immune deficiency syndrome (AIDS)

    • HIV testing is not required for entry into this protocol
    • Protocol-specific requirements may also exclude immuno-compromised patients
  • No prior allergic reaction to the study drug(s)
  • No other uncontrolled condition, which in the opinion of the investigator, would interfere in the safe and timely completion of study procedures
  • No comorbidity of uncontrolled diabetes (i.e., symptomatic hyperglycemia)
  • No other severe active comorbidity

PRIOR CONCURRENT THERAPY:

  • No prior systemic chemotherapy for the study cancer

    • Prior chemotherapy for a different cancer is allowed
  • No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • No initial surgical treatment (excluding diagnostic biopsy of the primary site or nodal sampling of neck disease)
  • No radical or modified neck dissection
  • No prior therapy that specifically and directly targets the EGFR pathway
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00265941

  Hide Study Locations
Locations
United States, Alabama
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
Birmingham, Alabama, United States, 35294
United States, Alaska
Providence Cancer Center
Anchorage, Alaska, United States, 99508
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Auburn Radiation Oncology
Auburn, California, United States, 95603
Alta Bates Summit Comprehensive Cancer Center
Berkeley, California, United States, 94704
Peninsula Medical Center
Burlingame, California, United States, 94010
Radiation Oncology Centers - Cameron Park
Cameron Park, California, United States, 95682
Mercy Cancer Center at Mercy San Juan Medical Center
Carmichael, California, United States, 95608
East Bay Radiation Oncology Center
Castro Valley, California, United States, 94546
Valley Medical Oncology Consultants - Castro Valley
Castro Valley, California, United States, 94546
Cancer Care Center at John Muir Health - Concord Campus
Concord, California, United States, 94524-4110
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Valley Medical Oncology
Fremont, California, United States, 94538
Virginia K. Crosson Cancer Center at St. Jude Medical Center
Fullerton, California, United States, 92835
Sutter Health - Western Division Cancer Research Group
Greenbrae, California, United States, 94904
Marin Cancer Institute at Marin General Hospital
Greenbrae, California, United States, 94904
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0658
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
Memorial Medical Center
Modesto, California, United States, 95355
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609
Larry G Strieff MD Medical Corporation
Oakland, California, United States, 94609
Tom K Lee, Incorporated
Oakland, California, United States, 94609
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, United States, 94609
Bay Area Breast Surgeons, Incorporated
Oakland, California, United States, 94609
Valley Medical Oncology Consultants - Pleasanton
Pleasanton, California, United States, 94588
Radiation Oncology Center - Roseville
Roseville, California, United States, 95661
Radiological Associates of Sacramento Medical Group, Incorporated
Sacramento, California, United States, 95815
Mercy General Hospital
Sacramento, California, United States, 95819
University of California Davis Cancer Center
Sacramento, California, United States, 95817
California Pacific Medical Center - California Campus
San Francisco, California, United States, 94118
San Francisco General Hospital Medical Center
San Francisco, California, United States, 94110
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
Doctors Medical Center - San Pablo Campus
San Pablo, California, United States, 94806
Stanford Cancer Center
Stanford, California, United States, 94305-5824
General Robert Huyser Cancer Center at David Grant Medical Center
Travis AFB, California, United States, 94535-1800
Solano Radiation Oncology Center
Vacaville, California, United States, 95687
Sutter Solano Medical Center
Vallejo, California, United States, 94589
John Muir/Mt. Diablo Comprehensive Cancer Center
Walnut Creek, California, United States, 94598
United States, Colorado
Aurora Presbyterian Hospital
Aurora, Colorado, United States, 80012
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States, 80045
Boulder Community Hospital
Boulder, Colorado, United States, 80301-9019
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States, 80933
St. Joseph Hospital
Denver, Colorado, United States, 80218
Veterans Affairs Medical Center - Denver
Denver, Colorado, United States, 80220
Presbyterian - St. Luke's Medical Center
Denver, Colorado, United States, 80218
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Swedish Medical Center
Englewood, Colorado, United States, 80110
Poudre Valley Radiation Oncology
Fort Collins, Colorado, United States, 80528
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
Grand Junction, Colorado, United States, 81502
North Colorado Medical Center
Greeley, Colorado, United States, 80631
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
Hope Cancer Care Center at Longmont United Hospital
Longmont, Colorado, United States, 80502
McKee Medical Center
Loveland, Colorado, United States, 80539
St. Mary - Corwin Regional Medical Center
Pueblo, Colorado, United States, 81004
North Suburban Medical Center
Thornton, Colorado, United States, 80229
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
United States, Delaware
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
Washington Cancer Institute at Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood, Florida, United States, 33021
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, United States, 32207
Integrated Community Oncology Network at Southside Cancer Center
Jacksonville, Florida, United States, 32207
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
Integrated Community Oncology Network
Jacksonville Beach, Florida, United States, 32250
Baptist Medical Center South
Jascksonville, Florida, United States, 32258
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
Jupiter, Florida, United States, 33458
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Integrated Community Oncology Network - Orange Park
Orange Park, Florida, United States, 32073
M.D. Anderson Cancer Center at Orlando
Orlando, Florida, United States, 32806
Florida Cancer Center - Palatka
Palatka, Florida, United States, 32177
Bay Medical
Panama City, Florida, United States, 32401
Flagler Cancer Center
Saint Augustine, Florida, United States, 32086
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States, 33612-9497
United States, Georgia
Winship Cancer Institute of Emory University
Altanta, Georgia, United States, 30322
CCOP - Atlanta Regional
Atlanta, Georgia, United States, 30342
Emory Crawford Long Hospital
Atlanta, Georgia, United States, 30308
Georgia Cancer Center for Excellence at Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, United States, 30342-1701
Northside Hospital Cancer Center
Atlanta, Georgia, United States, 30342-1611
Piedmont Hospital
Atlanta, Georgia, United States, 30309
Charles B. Eberhart Cancer Center at DeKalb Medical Center
Decatur, Georgia, United States, 30033
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, United States, 30033
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
Medical Center of Central Georgia
Macon, Georgia, United States, 31208
Kennestone Cancer Center at Wellstar Kennestone Hospital
Marietta, Georgia, United States, 30060
Southern Regional Medical Center
Riverdale, Georgia, United States, 30274-2600
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
Savannah, Georgia, United States, 31405
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States, 31403-3089
United States, Idaho
Mountain States Tumor Institute at St. Luke's Regional Medical Center
Boise, Idaho, United States, 83712
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
United States, Illinois
Saint Anthony's Hospital at Saint Anthony's Health Center
Alton, Illinois, United States, 62002
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60504
Good Shepherd Hospital
Barrington, Illinois, United States, 60010
St. Joseph Medical Center
Bloomington, Illinois, United States, 61701
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612-7243
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, United States, 60612-3785
Rush University Medical Center
Chicago, Illinois, United States, 60612
Creticos Cancer Center at Advocate Illinois Masonic Medical Center
Chicago, Illinois, United States, 60657
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Good Samaritan Cancer Care Center at Advocate Good Samaritan Hospital
Downers Grove, Illinois, United States, 60515-1500
InterCommunity Cancer Center of Western Illinois
Galesburg, Illinois, United States, 61401
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
Community Cancer Center
Normal, Illinois, United States, 61761
BroMenn Regional Medical Center
Normal, Illinois, United States, 61761
Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields
Olympia Fields, Illinois, United States, 60461
Advocate Lutheran General Cancer Care Center
Park Ridge, Illinois, United States, 60068-1174
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States, 61554
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States, 61615
OSF St. Francis Medical Center
Peoria, Illinois, United States, 61615-7827
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61615
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
Swedish-American Regional Cancer Center
Rockford, Illinois, United States, 61104-2315
Center for Cancer Care at OSF Saint Anthony Medical Center
Rockford, Illinois, United States, 61108
Valley Cancer Center
Spring Valley, Illinois, United States, 61362
Cancer Institute at St. John's Hospital
Springfield, Illinois, United States, 62702
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States, 61801
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
Saint John's Cancer Center at Saint John's Medical Center
Anderson, Indiana, United States, 46016
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States, 46107
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Parkview Regional Cancer Center at Parkview Health
Fort Wayne, Indiana, United States, 46805
Radiation Oncology Associates Southwest
Fort Wayne, Indiana, United States, 46804
Center for Cancer Care at Goshen General Hospital
Goshen, Indiana, United States, 46526
Methodist Cancer Center at Methodist Hospital
Indianapolis, Indiana, United States, 46202
Howard Community Hospital
Kokomo, Indiana, United States, 46904
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States, 46350
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States, 46360
Reid Hospital & Health Care Services
Richmond, Indiana, United States, 47374
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
United States, Iowa
McFarland Clinic, PC
Ames, Iowa, United States, 50010
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101
United States, Kansas
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
Menorah Medical Center
Overland Park, Kansas, United States, 66209
Shawnee Mission Medical Center
Shawnee Mission, Kansas, United States, 66204
Cotton-O'Neil Cancer Center
Topeka, Kansas, United States, 66606
United States, Kentucky
Lucille P. Markey Cancer Center at University of Kentucky
Lexington, Kentucky, United States, 40536-0093
James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States, 40292
United States, Louisiana
Tulane Cancer Center Office of Clinical Research
Alexandria, Louisiana, United States, 71315-3198
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge, Louisiana, United States, 70809
Pennington Cancer Center at Baton Rouge General
Baton Rouge, Louisiana, United States, 70806
Medical Center of Louisiana - New Orleans
New Orleans, Louisiana, United States, 70112
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Shreveport, Louisiana, United States, 71130-3932
United States, Maryland
St. Agnes Hospital Cancer Center
Baltimore, Maryland, United States, 21229
United States, Massachusetts
Boston University Cancer Research Center
Boston, Massachusetts, United States, 02118
Tufts-NEMC Cancer Center
Boston, Massachusetts, United States, 02111
Lahey Clinic Medical Center - Burlington
Burlington, Massachusetts, United States, 01805
NSMC Cancer Center - Peabody
Peabody, Massachusetts, United States, 01960
United States, Michigan
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, United States, 48106-0995
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States, 48123-2500
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, United States, 49431
Hurley Medical Center
Flint, Michigan, United States, 48503
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Great Lakes Cancer Institute at McLaren Regional Medical Center
Flint, Michigan, United States, 48532
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, United States, 49503
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
Dickinson County Healthcare System
Iron Mountain, Michigan, United States, 49801
Foote Memorial Hospital
Jackson, Michigan, United States, 49201
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
Sparrow Regional Cancer Center
Lansing, Michigan, United States, 48912-1811
St. Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, United States, 48060
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States, 48073
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, United States, 48601
Providence Cancer Institute at Providence Hospital - Southfield Campus
Southfield, Michigan, United States, 48075
Lakeland Regional Cancer Care Center - St. Joseph
St. Joseph, Michigan, United States, 49085
Munson Medical Center
Traverse City, Michigan, United States, 49684
St. John Macomb Hospital
Warren, Michigan, United States, 48093
United States, Minnesota
MeritCare Bemidji
Bemidji, Minnesota, United States, 56601
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
St. Luke's Hospital Cancer Care Center
Duluth, Minnesota, United States, 55805
CCOP - Duluth
Duluth, Minnesota, United States, 55805
Duluth Clinic Cancer Center - Duluth
Duluth, Minnesota, United States, 55805-1983
Miller - Dwan Medical Center
Duluth, Minnesota, United States, 55805
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota, United States, 55109
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States, 55422-2900
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, United States, 55416
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
United Hospital
Saint Paul, Minnesota, United States, 55102
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, United States, 55379
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
United States, Mississippi
University of Mississippi Cancer Clinic
Jackson, Mississippi, United States, 39216
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, United States, 39581
United States, Missouri
Cancer Institute of Cape Girardeau, LLC
Cape Girardeau, Missouri, United States, 63703
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
Cape Girardeau, Missouri, United States, 63701
Saint Francis Medical Center
Cape Girardeau, Missouri, United States, 63703
Independence Regional Health Center
Independence, Missouri, United States, 64050
St. Joseph Medical Center
Kansas City, Missouri, United States, 64114
Saint Luke's Cancer Institute at Saint Luke's Hospital
Kansas City, Missouri, United States, 64111
Truman Medical Center - Hospital Hill
Kansas City, Missouri, United States, 64108
Parvin Radiation Oncology
Kansas City, Missouri, United States, 64116
North Kansas City Hospital
Kansas City, Missouri, United States, 64116
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
Research Medical Center
Kansas City, Missouri, United States, 64132
Liberty Hospital
Liberty, Missouri, United States, 64068
Heartland Regional Medical Center
Saint Joseph, Missouri, United States, 64506
David C. Pratt Cancer Center at St. John's Mercy
Saint Louis, Missouri, United States, 63141
CCOP - St. Louis-Cape Girardeau
Saint Louis, Missouri, United States, 63141
Saint Louis University Cancer Center
Saint Louis, Missouri, United States, 63110
St. John's Regional Health Center
Springfield, Missouri, United States, 65804
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States, 65807
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65802
United States, Montana
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
Billings Clinic - Downtown
Billings, Montana, United States, 59107-7000
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
Great Falls, Montana, United States, 59405
Great Falls Clinic - Main Facility
Great Falls, Montana, United States, 59405
United States, Nebraska
Good Samaritan Cancer Center at Good Samaritan Hospital
Kearney, Nebraska, United States, 68848-1990
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
Creighton University Medical Center
Omaha, Nebraska, United States, 68131-2197
Alegant Health Cancer Center at Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
Immanuel Medical Center
Omaha, Nebraska, United States, 68122
Methodist Estabrook Cancer Center
Omaha, Nebraska, United States, 68114
United States, Nevada
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New Hampshire
Dartmouth - Hitchcock Concord
Concord, New Hampshire, United States, 03301
Kingsbury Center for Cancer Care at Cheshire Medical Center
Keene, New Hampshire, United States, 03431
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
Elliot Regional Cancer Center at Elliot Hospital
Manchester, New Hampshire, United States, 03103
United States, New Jersey
Ocean Medical Center at Meridian Health
Brick, New Jersey, United States, 08724
Princeton Radiation Oncology Center
Jamesburg, New Jersey, United States, 08831
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08901
University Medical Center at Princeton
Princeton, New Jersey, United States, 08540-3298
Frederick R. and Betty M. Smith Cancer Treatment Center
Sparta, New Jersey, United States, 07871
J. Phillip Citta Regional Cancer Center at Community Medical Center
Toms River, New Jersey, United States, 08755
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees, New Jersey, United States, 08043
United States, New Mexico
New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87109
United States, New York
Maimonides Cancer Center at Maimonides Medical Center
Brooklyn, New York, United States, 11219
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, United States, 13057
Charles R. Wood Cancer Center at Glens Falls Hospital
Glens Falls, New York, United States, 12801
St. Vincent's Comprehensive Cancer Center - Manhattan
New York, New York, United States, 10011
Highland Hospital of Rochester
Rochester, New York, United States, 14620
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States, 28801
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States, 28233-3549
Wayne Radiation Oncology
Goldsboro, North Carolina, United States, 27534
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
Leo W. Jenkins Cancer Center at ECU Medical School
Greenville, North Carolina, United States, 27834
Pardee Memorial Hospital
Hendersonville, North Carolina, United States, 28791
Cancer Centers of North Carolina - Raleigh
Raleigh, North Carolina, United States, 27607
Rex Cancer Center at Rex Hospital
Raleigh, North Carolina, United States, 27607
Wilmed Radiation Oncology Services
Wilson, North Carolina, United States, 27893
Forsyth Regional Cancer Center at Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
United States, North Dakota
CCOP - MeritCare Hospital
Fargo, North Dakota, United States, 58122
MeritCare Broadway
Fargo, North Dakota, United States, 58122
United States, Ohio
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, United States, 44309-2090
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States, 44307
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45267
CCOP - Columbus
Columbus, Ohio, United States, 43215
Grant Medical Center Cancer Care
Columbus, Ohio, United States, 43215
Doctors Hospital at Ohio Health
Columbus, Ohio, United States, 43228
Mount Carmel Health - West Hospital
Columbus, Ohio, United States, 43222
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States, 43214-3998
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States, 45409
CCOP - Dayton
Dayton, Ohio, United States, 45429
Grandview Hospital
Dayton, Ohio, United States, 45405
Good Samaritan Hospital
Dayton, Ohio, United States, 45406
Samaritan North Cancer Care Center
Dayton, Ohio, United States, 45415
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States, 45428
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Blanchard Valley Medical Associates
Findlay, Ohio, United States, 45840
Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States, 45429
St. Rita's Medical Center
Lima, Ohio, United States, 45801
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States, 43055
Mercy Medical Center
Springfield, Ohio, United States, 45504
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States, 45373-1300
Precision Radiotherapy at University Pointe
West Chester, Ohio, United States, 45069
Mount Carmel St. Ann's Cancer Center
Westerville, Ohio, United States, 43081
Cancer Treatment Center
Wooster, Ohio, United States, 44691
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States, 45385
United States, Oklahoma
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Bay Area Hospital
Coos Bay, Oregon, United States, 97420
Three Rivers Community Hospital
Grants Pass, Oregon, United States, 97527
Legacy Mount Hood Medical Center
Gresham, Oregon, United States, 97030
Dubs Cancer Center at Rogue Valley Medical Center
Medford, Oregon, United States, 97504
Providence Cancer Center at PMCC
Medford, Oregon, United States, 97504
Providence Milwaukie Hospital
Milwaukie, Oregon, United States, 97222
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States, 97213-2967
Legacy Emanuel Hospital and Health Center and Children's Hospital
Portland, Oregon, United States, 97227
Legacy Good Samaritan Hospital & Comprehensive Cancer Center
Portland, Oregon, United States, 97210
Adventist Medical Center
Portland, Oregon, United States, 97216
Oregon Health and Science University Cancer Institute
Portland, Oregon, United States, 97239-3098
Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
Legacy Meridian Park Hospital
Tualatin, Oregon, United States, 97062
United States, Pennsylvania
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, United States, 17822-0001
Mercy Fitzgerald Hospital
Darby, Pennsylvania, United States, 19023
Northeast Radiation Oncology Center
Dunmore, Pennsylvania, United States, 18512
Dale and Frances Hughes Cancer Center at Pocono Medical Center
East Stroudsburg, Pennsylvania, United States, 18301
Upper Delaware Valley Cancer Center
Milford, Pennsylvania, United States, 18337
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States, 19141
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
St. Joseph Medical Center
Reading, Pennsylvania, United States, 19604
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States, 18711
York Cancer Center at Apple Hill Medical Center
York, Pennsylvania, United States, 17405
United States, Rhode Island
Miriam Hospital
Providence, Rhode Island, United States, 02906
Rhode Island Hospital Comprehensive Cancer Center
Providence, Rhode Island, United States, 02903
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
CCOP - Greenville
Greenville, South Carolina, United States, 29615
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Texas
Harrington Cancer Center
Amarillo, Texas, United States, 79106
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234-6200
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Wilford Hall Medical Center
Lackland AFB, Texas, United States, 78236
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States, 79410-1894
United States, Utah
Sandra L. Maxwell Cancer Center
Cedar City, Utah, United States, 84720
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Murray, Utah, United States, 84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States, 84604
Dixie Regional Medical Center - East Campus
Saint George, Utah, United States, 84770
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, United States, 84106
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States, 84112
LDS Hospital
Salt Lake City, Utah, United States, 84143
United States, Vermont
Norris Cotton Cancer Center - North
Saint Johnsbury, Vermont, United States, 05819
United States, Virginia
INOVA Alexandria Hospital
Alexandria, Virginia, United States, 22304
Danville Regional Medical Center
Danville, Virginia, United States, 24541
Lynchburg Hematology-Oncology Clinic
Lynchburg, Virginia, United States, 24501
Sentara Cancer Institute at Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Naval Medical Center - Portsmouth
Portsmouth, Virginia, United States, 23708-2197
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, United States, 23249
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
United States, Washington
St. Francis Hospital
Federal Way, Washington, United States, 98003
Southwest Washington Medical Center Cancer Center
Vancouver, Washington, United States, 98668
United States, Wisconsin
Theda Care Cancer Institute
Appleton, Wisconsin, United States, 54911
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, United States, 54303
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States, 54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54301-3526
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, United States, 54601
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Columbia Saint Mary's Hospital - Ozaukee
Mequon, Wisconsin, United States, 53097
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Columbia-Saint Mary's Cancer Care Center
Milwaukee, Wisconsin, United States, 53211
Veterans Affairs Medical Center - Milwaukee
Milwaukee, Wisconsin, United States, 53295
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235
University of Wisconcin Cancer Center at Aspirus Wausau Hospital
Wausau, Wisconsin, United States, 54401
Canada, Alberta
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada, T2N 4N2
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Nova Scotia
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V8
Canada, Ontario
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada, K1Y 4K7
Northeastern Ontario Regional Cancer Centre
Sudbury, Ontario, Canada, P3E 5J1
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Hopital Notre-Dame du CHUM
Montreal, Quebec, Canada, H2L 4M1
McGill Cancer Centre at McGill University
Montreal, Quebec, Canada, H2W 1S6
Canada, Saskatchewan
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, Canada, S4T 7T1
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Principal Investigator: K. Kian Ang, MD, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
Publications:
Ang K, Zhang Q, Rosenthal DI, et al.: A randomized phase III trial (RTOG 0522) of concurrent accelerated radiation plus cisplatin with or without cetuximab for stage III-IV head and neck squamous cell carcinomas (HNC). [Abstract] J Clin Oncol 29 (Suppl 15): A-5500, 2011.

Responsible Party: Walter John Curran, Jr, Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00265941     History of Changes
Other Study ID Numbers: CDR0000458049, RTOG-0522
Study First Received: December 14, 2005
Last Updated: September 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
stage III squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the larynx
stage III squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Cetuximab
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013