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Radiation Therapy With or Without Cetuximab in Treating Patients Who Have Undergone Surgery for Locally Advanced Head and Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00956007
Recruitment Status : Active, not recruiting
First Posted : August 11, 2009
Last Update Posted : March 30, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Brief Summary:

RATIONALE: Giving radiation therapy that uses a 3-dimensional (3-D) image of the tumor to help focus thin beams of radiation directly on the tumor, and giving radiation therapy in higher doses over a shorter period of time, may kill more tumor cells and have fewer side effects. 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 when given alone or together with cetuximab in treating patients with head and neck cancer that has been removed by surgery.

PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with cetuximab in treating patients who have undergone surgery for locally advanced head and neck cancer.


Condition or disease Intervention/treatment Phase
Head and Neck Cancer Biological: cetuximab Radiation: intensity-modulated radiation therapy Phase 3

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Detailed Description:

OBJECTIVES:

Primary

  • Determine whether the addition of cetuximab to postoperative intensity-modulated radiotherapy (IMRT) will improve overall survival (OS) in patients with locally advanced squamous cell carcinoma of the head and neck at intermediate risk following surgery.

Secondary

  • Assess the impact of the addition of cetuximab to postoperative IMRT on disease-free survival (DFS) of these patients.
  • Assess the impact of the addition of cetuximab to postoperative IMRT on acute and late dysphagia, xerostomia, skin toxicity, and other toxicities according to common Toxicity Criteria for Adverse Effects (CTCAE), v. 4 and their relationships with patient-reported outcomes at 3, 12, and 24 months.
  • Analyze tumor for epidermal growth factor receptor (EGFR), specifically the extent of EGFR overexpression by immuno-histochemistry (IHC) and FISH analysis, EGFRvIII expression, as well as the association of these assay data with OS and DFS.
  • Analyze tumor for human papillomavirus (HPV) infection (as defined by in situ hybridization), specifically, within the cohort of patients with oropharynx cancer, to perform an exploratory analysis of the impact of HPV on DFS and OS of this patient subset.
  • Analyze tumor DNA for TP53 mutations as a predictor of response to cetuximab and prognosis.
  • Analyze germline DNA of polymorphic variants in EGFR intron repeats as a predictor of response to cetuximab.

Tertiary

  • Assess the impact of the addition of cetuximab to postoperative IMRT on loco-regional control.
  • Assess the impact of the addition of cetuximab to postoperative IMRT on patient-reported quality of life, swallowing, xerostomia, and skin toxicity based on head and neck specific instruments, including the Performance Status Scale for Head and Neck Cancer (PSS-HN), the Functional Assessment of Cancer Therapy-Head & Neck (FACT-H&N), the University of Michigan Xerostomia-Related Quality of Life Scale (XeQOLS), and the Dermatology Life Quality Index (DLQI).
  • Assess the impact of the addition of cetuximab to postoperative IMRT on cost-utility analysis using the EuroQol (EQ-5D).
  • Evaluate the utility of image-guided radiotherapy (IGRT) as a means of enhancing the efficacy (i.e., loco-regional control) of IMRT while reducing the acute and/or late toxicity (particularly xerostomia) and improving patient-reported outcomes (particularly XeQOLS scores).
  • Retrospectively compare the loco-regional control rate in patients treated with IMRT alone (no IGRT or cetuximab) with similar patients treated with external beam radiotherapy alone in the postoperative clinical trial Radiation Therapy Oncology Group (RTOG)-95 01.

OUTLINE: This is a multicenter study. Patients are stratified according to clinical stage (T2-3 vs T4a), EGFR expression (high [≥ 80% of cells staining positive] vs low [< 80% of cells staining positive] vs not evaluable), primary site of disease (oral cavity vs larynx vs oropharynx p16+ vs oropharynx p16- vs oropharynx, p16 not evaluable), and use of image-guided radiotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo intensity-modulated radiotherapy (IMRT) once daily 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients undergo IMRT as in arm I. Patients also receive cetuximab IV over 1-2 hours once weekly beginning at least 5 days prior to the start of IMRT and continuing for 4 weeks after the completion of IMRT (for a total of 11 doses) in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and at 3, 12, and 24 months.

Tissue samples are collected periodically for further laboratory analysis.

After completion of study treatment, patients are followed up at 1 and 3 months, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 703 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally-Advanced Resected Head and Neck Cancer
Actual Study Start Date : November 2009
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Arm I: Intensity-Modulated Radiotherapy
Patients undergo intensity-modulated radiotherapy (IMRT) once daily 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.
Radiation: intensity-modulated radiation therapy
Patients undergo radiotherapy.
Experimental: Arm II: IMRT plus cetuximab
Patients undergo IMRT as in arm I. Patients also receive cetuximab IV over 1-2 hours once weekly beginning at least 5 days prior to the start of IMRT and continuing for 4 weeks after the completion of IMRT (for a total of 11 doses) in the absence of disease progression or unacceptable toxicity.
Biological: cetuximab
Given IV
Radiation: intensity-modulated radiation therapy
Patients undergo radiotherapy.



Primary Outcome Measures :
  1. Overall survival [ Time Frame: From randomization to date of death or last follow-up. Analysis occurs after 372 events have been reported. ]

Secondary Outcome Measures :
  1. Adverse events (dysphagia, xerostomia, and skin toxicity) according to CTCAE, v. 4 and their relationships with patient-reported outcomes at 3, 12, and 24 months [ Time Frame: From start of treatment to 2 years after end of treatment. ]
  2. Other acute adverse events (≤ 90 days from start of radiotherapy [RT]) according to CTCAE, v. 4 [ Time Frame: From start of treatment to 90 days. ]
  3. Other late adverse events (> 90 days from start of RT) according to CTCAE, v. 4 [ Time Frame: From 90 days after start of treatment to last follow-up. ]
  4. Disease-free survival [ Time Frame: From randomization to date of failure (local, regional or distant progression or death) or last follow-up. Analysis occurs at the same time as the primary outcome. ]
  5. Loco-regional control [ Time Frame: From randomization to date of failure (local or regional progression or distant progression or death) or last follow-up. Analysis occurs at the same time as the primary outcome. ]
  6. Quality of life as measured by Functional Assessment of Cancer Therapy-Head & Neck (FACT-HN) and EuroQol (EQ-5D) at baseline and at 3, 12, and 24 months [ Time Frame: From randomization to 2 years. ]
  7. Xerostomia as measured by University of Michigan Xerostomia-Related Quality of Life Scale (XeQOLS) at baseline and at 3, 12, and 24 months [ Time Frame: From randomization to 2 years. ]
  8. Swallowing as measured by the normalcy of diet subscale of the Performance Status Scale for Head and Neck Cancer (PSS-HN) at baseline and at 3, 12, and 24 months [ Time Frame: From randomization to 2 years. ]
  9. Skin toxicity as measured by the Dermatology Life Quality Index (DLQI) at baseline and at 3, 12, and 24 months [ Time Frame: From randomization to 2 years. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed squamous cell carcinoma (including variants, such as verrucous carcinoma, spindle cell carcinoma, or carcinoma not otherwise specified) of the head and neck, including the following subtypes:

    • Oral cavity
    • Oropharynx
    • Larynx
  • Clinical stage T1, N1-2, M0 OR T2-4a, N0-2, M0 disease based on the following diagnostic workup within the past 8 weeks:

    • General history and physical examination by a Radiation Oncologist and/or Medical Oncologist
    • Chest x-ray or chest CT scan (with or without contrast) or chest CT/PET scan (with or without contrast)
  • Must have undergone gross total resection of the primary tumor with curative intent within the past 7 weeks with surgical pathology demonstrating ≥ 1 of the following criteria for "intermediate" risk of recurrence:

    • Perineural invasion
    • Lymphovascular invasion
    • Single lymph node > 3 cm or ≥ 2 lymph nodes (all < 6 cm) (no extracapsular extension)
    • Close margin(s) of resection, defined as cancer extending to within 5 mm of a surgical margin, and/or an initially focally positive margin that is subsequently superseded by intraoperative negative margins (similarly, patients whose tumors had focally positive margins in the main specimen but negative margins from re-excised samples in the region of the positive margin are eligible)
    • Pathologically confirmed T3 or T4a primary tumor
    • T2 oral cavity cancer with > 5 mm depth of invasion
  • No positive margin(s) (defined as tumor present at the cut or inked edge of the tumor), nodal extracapsular extension, and/or gross residual disease after surgery

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1
  • Absolute granulocyte count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed)
  • Total bilirubin < 2 times upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 times ULN
  • Serum creatinine < 2 times ULN OR creatinine clearance ≥ 50 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other invasive malignancy within the past 3 years, except for nonmelanomatous skin cancer or previously treated carcinoma in situ of the breast, oral cavity, or cervix
  • No simultaneous primary or bilateral tumors
  • No severe, active co-morbidity, including any of the following:

    • Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
    • Transmural myocardial infarction within the past 6 months
    • Acute bacterial or fungal infection requiring IV antibiotics at the time of study registration
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy
    • Idiopathic pulmonary fibrosis or other severe interstitial lung disease that requires oxygen therapy or is thought to have required oxygen therapy within the past year
    • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
    • AIDS based on current Centers for Disease Control (CDC) definition
    • Grade 3-4 electrolyte abnormalities according to CTCAE, v. 4, including any of the following:

      • Serum calcium (ionized or adjusted for albumin) < 7 mg/dL or > 12.5 mg/dL*
      • Glucose < 40 mg/dL or > 250 mg/dL
      • Magnesium < 0.9 mg/dL or > 3 mg/dL*
      • Potassium < 3.0 mmol/L or > 6 mmol/L*
      • Sodium < 130 mmol/L or > 155 mmol/L* NOTE: *Despite intervention to normalize levels.
  • No prior allergic reaction to cetuximab

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior systemic chemotherapy or anti-epidermal growth factor (EGF) therapy for this cancer

    • Prior chemotherapy or anti-EGF therapy for a different cancer allowed
  • No prior radiotherapy to the region of the study cancer that would result in overlap of radiotherapy fields
  • No concurrent amifostine as a radioprotector
  • No concurrent granulocyte colony-stimulating factor or erythropoietin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00956007


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Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Arizona Oncology Associates-West Orange Grove
Tucson, Arizona, United States, 85704
United States, California
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, United States, 95603
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, United States, 95682
Mercy San Juan Medical Center
Carmichael, California, United States, 95608
City of Hope
Duarte, California, United States, 91010
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States, 90027
Los Angeles County-USC Medical Center
Los Angeles, California, United States, 90033
University of Southern California/Norris Cancer Center
Los Angeles, California, United States, 90033
Memorial Medical Center
Modesto, California, United States, 95355
Bay Area Tumor Institute CCOP
Oakland, California, United States, 94609
Pomona Valley Hospital Medical Center
Pomona, California, United States, 91767
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, United States, 95661
The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California, United States, 95678
Sutter General Hospital
Sacramento, California, United States, 95816
University of California at Davis Cancer Center
Sacramento, California, United States, 95817
Mercy General Hospital Radiation Oncology Center
Sacramento, California, United States, 95819
Saint Helena Hospital
Saint Helena, California, United States, 94574
UCSF-Mount Zion
San Francisco, California, United States, 94115
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States, 95051
Stanford University Hospitals and Clinics
Stanford, California, United States, 94305
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Vacaville, California, United States, 95687
United States, Colorado
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, United States, 80012
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States, 80907
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Swedish Medical Center
Englewood, Colorado, United States, 80113
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, United States, 80120
United States, Connecticut
Saint Vincent's Medical Center
Bridgeport, Connecticut, United States, 06606
Yale University
New Haven, Connecticut, United States, 06520
William Backus Hospital
Norwich, Connecticut, United States, 06360
United States, Delaware
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718
United States, Florida
University of Miami Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States, 33442
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
Baptist Hospital of Miami
Miami, Florida, United States, 33176
Florida Hospital
Orlando, Florida, United States, 32803
UF Cancer Center at Orlando Health
Orlando, Florida, United States, 32806
United States, Georgia
Emory University/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Atlanta VA Medical Center
Decatur, Georgia, United States, 30033
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
Memorial Health University Medical Center
Savannah, Georgia, United States, 31403
Saint Joseph's-Candler Health System
Savannah, Georgia, United States, 31405
United States, Hawaii
Queen's Medical Center
Honolulu, Hawaii, United States, 96813
University of Hawaii
Honolulu, Hawaii, United States, 96813
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, United States, 96817
United States, Idaho
Saint Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
United States, Illinois
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, United States, 60612-3785
University of Illinois
Chicago, Illinois, United States, 60612
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States, 60201
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Hines Veterans Administration Hospital
Hines, Illinois, United States, 60141
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Saint John's Hospital
Springfield, Illinois, United States, 62702
Memorial Medical Center
Springfield, Illinois, United States, 62781-0001
Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
Radiation Oncology Associates PC
Fort Wayne, Indiana, United States, 46804
Parkview Hospital Randallia
Fort Wayne, Indiana, United States, 46805
IU Health Methodist Hospital
Indianapolis, Indiana, United States, 46202
Community Regional Cancer Care-East Radiation Oncology
Indianapolis, Indiana, United States, 46219
Community Regional Cancer Care-North
Indianapolis, Indiana, United States, 46256
IU Health Ball Memorial Hospital
Muncie, Indiana, United States, 47303
United States, Iowa
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, United States, 50010
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Siouxland Hematology Oncology Associates
Sioux City, Iowa, United States, 51101
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States, 40202
United States, Louisiana
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States, 70809
Tulane University Health Sciences Center
New Orleans, Louisiana, United States, 70112
Touro Infirmary
New Orleans, Louisiana, United States, 70115
United States, Maine
Central Maine Medical Center
Lewiston, Maine, United States, 04240
United States, Maryland
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Peninsula Regional Medical Center
Salisbury, Maryland, United States, 21801
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Boston Medical Center
Boston, Massachusetts, United States, 02118
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States, 01805
United States, Michigan
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
University of Michigan
Ann Arbor, Michigan, United States, 48109
Oakwood Hospital
Dearborn, Michigan, United States, 48124
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Saint Mary's of Michigan
Saginaw, Michigan, United States, 48601
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States, 48093
United States, Minnesota
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Saint Luke's Hospital of Duluth
Duluth, Minnesota, United States, 55805
Unity Hospital
Fridley, Minnesota, United States, 55432
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States, 55109
Mayo Clinic
Rochester, Minnesota, United States, 55905
Regions Hospital
Saint Paul, Minnesota, United States, 55101
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Singing River Hospital
Pascagoula, Mississippi, United States, 39581
United States, Missouri
Cape Radiation Oncology
Cape Girardeau, Missouri, United States, 63703
University of Missouri - Ellis Fischel
Columbia, Missouri, United States, 65212
Kansas City Cancer Centers - North
Kansas City, Missouri, United States, 64154
Kansas City Cancer Center-Lee's Summit
Lee's Summit, Missouri, United States, 64064
Saint Louis University Hospital
Saint Louis, Missouri, United States, 63110
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Siteman Cancer Center-South County
Saint Louis, Missouri, United States, 63129
Missouri Baptist Medical Center
Saint Louis, Missouri, United States, 63131
Barnes-Jewish West County Hospital
Saint Louis, Missouri, United States, 63141
Saint John's Mercy Medical Center
Saint Louis, Missouri, United States, 63141
Siteman Cancer Center - Saint Peters
Saint Peters, Missouri, United States, 63376
Mercy Hospital Springfield
Springfield, Missouri, United States, 65804
CoxHealth South Hospital
Springfield, Missouri, United States, 65807
United States, Nebraska
Saint Elizabeth Regional Medical Center
Lincoln, Nebraska, United States, 68510
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
The Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, Nevada
Renown Regional Medical Center
Reno, Nevada, United States, 89502
United States, New Hampshire
Exeter Hospital
Exeter, New Hampshire, United States, 03833
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Memorial Sloan Kettering Cancer Center at Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Cooper Hospital University Medical Center
Camden, New Jersey, United States, 08103
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
Mount Holly, New Jersey, United States, 08060
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08901
UMDNJ - New Jersey Medical School
Newark, New Jersey, United States, 07103
Sparta Cancer Treatment Center
Sparta, New Jersey, United States, 07871
MD Anderson Cancer Center at Cooper-Voorhees
Voorhees, New Jersey, United States, 08043
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87106
United States, New York
New York Oncology Hematology PC - Albany
Albany, New York, United States, 12206
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Sands Cancer Center
Canandaigua, New York, United States, 14424
Memorial Sloan Kettering Cancer Center Commack
Commack, New York, United States, 11725
Beth Israel Medical Center
New York, New York, United States, 10003
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Highland Hospital
Rochester, New York, United States, 14620
University Radiation Oncology
Rochester, New York, United States, 14626
University of Rochester
Rochester, New York, United States, 14642
Memorial Sloan-Kettering Cancer Center Rockville Centre
Rockville Centre, New York, United States, 11570
Memorial Sloan-Kettering Cancer Center at Sleepy Hallow
Sleepy Hollow, New York, United States, 10591
United States, North Carolina
Mission Hospital-Memorial Campus
Asheville, North Carolina, United States, 28801
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Wayne Radiation Oncology
Goldsboro, North Carolina, United States, 27534
Kinston Medical Specialists PA
Kinston, North Carolina, United States, 28501
Cancer Centers of North Carolina
Raleigh, North Carolina, United States, 27607
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, North Dakota
Roger Maris Cancer Center
Fargo, North Dakota, United States, 58122
United States, Ohio
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, United States, 44304
Akron General Medical Center
Akron, Ohio, United States, 44307
Summa Barberton Hospital
Barberton, Ohio, United States, 44203
Mercy Medical Center
Canton, Ohio, United States, 44708
Geaugra Hospital
Chardon, Ohio, United States, 44024
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States, 44111
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Mercy Cancer Center-Elyria
Elyria, Ohio, United States, 44035
Cleveland Clinic Cancer Center Independence
Independence, Ohio, United States, 44131
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, United States, 44124
Summa Health Center at Lake Medina
Medina, Ohio, United States, 44256
Lake University Ireland Cancer Center
Mentor, Ohio, United States, 44060
Southwest General Health Center Ireland Cancer Center
Middleburg Heights, Ohio, United States, 44130
UHHS-Chagrin Highlands Medical Center
Orange Village, Ohio, United States, 44122
Saint Charles Hospital
Oregon, Ohio, United States, 43616
Robinson Radiation Oncology
Ravenna, Ohio, United States, 44266
North Coast Cancer Care
Sandusky, Ohio, United States, 44870
Cleveland Clinic Cancer Center-Strongsville
Strongsville, Ohio, United States, 44136
Flower Hospital
Sylvania, Ohio, United States, 43560
University Pointe
West Chester, Ohio, United States, 45069
UHHS-Westlake Medical Center
Westlake, Ohio, United States, 44145
Cleveland Clinic Wooster Specialty Center
Wooster, Ohio, United States, 44691
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States, 97015
Willamette Valley Cancer Center
Eugene, Oregon, United States, 97401
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Western Oncology Research Consortium
Portland, Oregon, United States, 97213
Providence Saint Vincent Medical Center
Portland, Oregon, United States, 97225
Oregon Health and Science University
Portland, Oregon, United States, 97239
Portland Veterans Administration Medical Center
Portland, Oregon, United States, 97239
Salem Hospital
Salem, Oregon, United States, 97301
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18105
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-2001
Northeast Radiation Oncology Center
Dunmore, Pennsylvania, United States, 18512
Pocono Medical Center
East Stroudsburg, Pennsylvania, United States, 18301
Adams Cancer Center
Gettysburg, Pennsylvania, United States, 17325
Cherry Tree Cancer Center
Hanover, Pennsylvania, United States, 17331
Saint Mary Medical and Regional Cancer Center
Langhorne, Pennsylvania, United States, 19047
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
Reading Hospital
West Reading, Pennsylvania, United States, 19611
WellSpan Health-York Hospital
York, Pennsylvania, United States, 17405
United States, South Carolina
AnMed Health Cancer Center
Anderson, South Carolina, United States, 29621
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, United States, 29605
Greenville Health System Cancer Institute/Greenville CCOP
Greenville, South Carolina, United States, 29615
Gibbs Cancer Center-Pelham
Greer, South Carolina, United States, 29651
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, United States, 29307
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
Sanford Cancer Center-Oncology Clinic
Sioux Falls, South Dakota, United States, 57104
United States, Tennessee
Wellmont Holston Valley Hospital and Medical Center
Kingsport, Tennessee, United States, 37660
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Oncology-Austin Midtown
Austin, Texas, United States, 78705
Texas Oncology - Central Austin Cancer Center
Austin, Texas, United States, 78731
Texas Oncology - South Austin Cancer Center
Austin, Texas, United States, 78745
Texas Oncology PA - Bedford
Bedford, Texas, United States, 76022
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Texas Oncology-Denton South
Denton, Texas, United States, 76210
The Klabzuba Cancer Center
Fort Worth, Texas, United States, 76104
Memorial Hermann Memorial City Medical Center
Houston, Texas, United States, 77024
Ben Taub General Hospital
Houston, Texas, United States, 77030
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Texas Oncology-Seton Williamson
Round Rock, Texas, United States, 78665
Texas Oncology - Round Rock Cancer Center
Round Rock, Texas, United States, 78681
Cancer Care Centers of South Texas- Northeast
San Antonio, Texas, United States, 78217
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Texas Cancer Center-Sherman
Sherman, Texas, United States, 75090
Texas Oncology Cancer Center Sugar Land
Sugar Land, Texas, United States, 77479
Texas Oncology-Wichita Falls Texoma Cancer Center
Wichita Falls, Texas, United States, 76310
United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84157
Dixie Medical Center Regional Cancer Center
Saint George, Utah, United States, 84770
Utah Cancer Specialists-Salt Lake City
Salt Lake City, Utah, United States, 84106
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
LDS Hospital
Salt Lake City, Utah, United States, 84143
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sentara Cancer Institute at Sentara CarePlex Hospital
Hampton, Virginia, United States, 23666
Sentara Hospitals
Norfolk, Virginia, United States, 23507
Hunter Holmes McGuire Veterans Administration Medical Center
Richmond, Virginia, United States, 23249
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sentara Virginia Beach General Hospital
Virginia Beach, Virginia, United States, 23454
United States, Washington
Harrison Medical Center
Bremerton, Washington, United States, 98310
Tri-Cities Cancer Center
Kennewick, Washington, United States, 99336
Skagit Valley Hospital
Mount Vernon, Washington, United States, 98274
University of Washington Medical Center
Seattle, Washington, United States, 98195
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
Cancer Care Northwest-North Spokane
Spokane, Washington, United States, 99218
Northwest CCOP
Tacoma, Washington, United States, 98405
PeaceHealth Southwest Medical Center
Vancouver, Washington, United States, 98664
Compass Oncology Vancouver
Vancouver, Washington, United States, 98684
Wenatchee Valley Medical Center
Wenatchee, Washington, United States, 98801
United States, West Virginia
West Virginia University Healthcare
Morgantown, West Virginia, United States, 26506
Wheeling Hospital
Wheeling, West Virginia, United States, 26003
United States, Wisconsin
Langlade Hospital and Cancer Center
Antigo, Wisconsin, United States, 54409
Fox Valley Hematology and Oncology
Appleton, Wisconsin, United States, 54911-3496
Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301
Gundersen Lutheran
La Crosse, Wisconsin, United States, 54601
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Clement J. Zablocki VA Medical Center
Milwaukee, Wisconsin, United States, 53295
Door County Cancer Center
Sturgeon Bay, Wisconsin, United States, 54235-1495
Aspirus Regional Cancer Center
Wausau, Wisconsin, United States, 54401
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Newfoundland and Labrador
Doctor H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Ontario
London Regional Cancer Program
London, Ontario, Canada, N6A 4L6
Ottawa Health Research Institute-General Division
Ottawa, Ontario, Canada, K1H 1C4
Health Sciences North
Sudbury, Ontario, Canada, P3E 5J1
University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
CHUM - Hopital Notre-Dame
Montreal, Quebec, Canada, H2L 4M1
McGill University Department of Oncology
Montreal, Quebec, Canada, H2W 1S6
CHUQ - Pavilion Hotel-Dieu de Quebec
Quebec City, Quebec, Canada, G1R 2J6
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke, Quebec, Canada, J1H 5N4
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
China, Hong Kong
Chinese University of Hong Kong-Prince of Wales Hospital
Shatin, Hong Kong, China, OX1 3UJ
Saudi Arabia
King Faisal Specialist Hospital and Research Centre
Riyadh, Saudi Arabia, 11211
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
NRG Oncology
Investigators
Study Chair: Mitchell Machtay, MD University Hospitals Seidman Cancer Center

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00956007     History of Changes
Obsolete Identifiers: NCT01311063
Other Study ID Numbers: RTOG 0920
CDR0000651536
NCI-2011-00878 ( Registry Identifier: CTRP (Clinical Trials Reporting Program )
First Posted: August 11, 2009    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018

Keywords provided by Radiation Therapy Oncology Group:
stage III squamous cell carcinoma of the larynx
stage III verrucous carcinoma of the larynx
stage IV squamous cell carcinoma of the larynx
stage IV verrucous carcinoma of the larynx
stage III squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity
stage III verrucous carcinoma of the oral cavity
stage IV verrucous carcinoma of the oral cavity
stage III squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx
tongue cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Cetuximab
Antineoplastic Agents