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

Primary Purpose

Head and Neck Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
cetuximab
intensity-modulated radiation therapy
Sponsored by
Radiation Therapy Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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cancer extending to within 5 mm of a surgical margin, and/or an initially focally positive margin that is subsequently superseded by intraoperative negative margins (similarly, patients whose tumors had focally positive margins in the main specimen but negative margins from re-excised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

Sites / Locations

  • University of Alabama at Birmingham
  • Arizona Oncology Associates-West Orange Grove
  • Sutter Cancer Centers Radiation Oncology Services-Auburn
  • Sutter Cancer Centers Radiation Oncology Services-Cameron Park
  • Mercy San Juan Medical Center
  • City of Hope
  • UC San Diego Moores Cancer Center
  • Kaiser Permanente Los Angeles Medical Center
  • Los Angeles County-USC Medical Center
  • University of Southern California/Norris Cancer Center
  • Memorial Medical Center
  • Bay Area Tumor Institute CCOP
  • Pomona Valley Hospital Medical Center
  • Sutter Cancer Centers Radiation Oncology Services-Roseville
  • The Permanente Medical Group-Roseville Radiation Oncology
  • Sutter General Hospital
  • University of California at Davis Cancer Center
  • Mercy General Hospital Radiation Oncology Center
  • Saint Helena Hospital
  • UCSF-Mount Zion
  • Kaiser Permanente Medical Center - Santa Clara
  • Stanford University Hospitals and Clinics
  • Sutter Cancer Centers Radiation Oncology Services-Vacaville
  • Rocky Mountain Cancer Centers-Aurora
  • University of Colorado Cancer Center - Anschutz Cancer Pavilion
  • Penrose-Saint Francis Healthcare
  • Porter Adventist Hospital
  • Swedish Medical Center
  • Rocky Mountain Cancer Centers-Littleton
  • Saint Vincent's Medical Center
  • Yale University
  • William Backus Hospital
  • Christiana Care Health System-Christiana Hospital
  • University of Miami Sylvester Comprehensive Cancer Center at Deerfield Beach
  • Mayo Clinic in Florida
  • University of Miami Miller School of Medicine-Sylvester Cancer Center
  • Baptist Hospital of Miami
  • Florida Hospital
  • UF Cancer Center at Orlando Health
  • Emory University/Winship Cancer Institute
  • Atlanta VA Medical Center
  • Northeast Georgia Medical Center
  • Memorial Health University Medical Center
  • Saint Joseph's-Candler Health System
  • Queen's Medical Center
  • University of Hawaii
  • The Cancer Center of Hawaii-Liliha
  • Saint Alphonsus Regional Medical Center
  • John H Stroger Jr Hospital of Cook County
  • University of Illinois
  • NorthShore University HealthSystem-Evanston Hospital
  • Ingalls Memorial Hospital
  • Hines Veterans Administration Hospital
  • Loyola University Medical Center
  • Saint John's Hospital
  • Memorial Medical Center
  • Carle Cancer Center
  • Radiation Oncology Associates PC
  • Parkview Hospital Randallia
  • IU Health Methodist Hospital
  • Community Regional Cancer Care-East Radiation Oncology
  • Community Regional Cancer Care-North
  • IU Health Ball Memorial Hospital
  • McFarland Clinic PC-William R Bliss Cancer Center
  • Iowa Methodist Medical Center
  • Mercy Medical Center - Des Moines
  • University of Iowa Hospitals and Clinics
  • Siouxland Hematology Oncology Associates
  • University of Kansas Medical Center
  • University of Kentucky
  • The James Graham Brown Cancer Center at University of Louisville
  • Mary Bird Perkins Cancer Center
  • Tulane University Health Sciences Center
  • Touro Infirmary
  • Central Maine Medical Center
  • University of Maryland/Greenebaum Cancer Center
  • Peninsula Regional Medical Center
  • Tufts Medical Center
  • Boston Medical Center
  • Lahey Hospital and Medical Center
  • Saint Joseph Mercy Hospital
  • University of Michigan
  • Oakwood Hospital
  • Wayne State University/Karmanos Cancer Institute
  • Henry Ford Hospital
  • Saint John Hospital and Medical Center
  • West Michigan Cancer Center
  • Saint Mary's of Michigan
  • Saint John Macomb-Oakland Hospital
  • Mercy Hospital
  • Saint Luke's Hospital of Duluth
  • Unity Hospital
  • Minnesota Oncology Hematology PA-Maplewood
  • Mayo Clinic
  • Regions Hospital
  • University of Mississippi Medical Center
  • Singing River Hospital
  • Cape Radiation Oncology
  • University of Missouri - Ellis Fischel
  • Kansas City Cancer Centers - North
  • Kansas City Cancer Center-Lee's Summit
  • Saint Louis University Hospital
  • Washington University School of Medicine
  • Siteman Cancer Center-South County
  • Missouri Baptist Medical Center
  • Barnes-Jewish West County Hospital
  • Saint John's Mercy Medical Center
  • Siteman Cancer Center - Saint Peters
  • Mercy Hospital Springfield
  • CoxHealth South Hospital
  • Saint Elizabeth Regional Medical Center
  • Nebraska Methodist Hospital
  • The Nebraska Medical Center
  • Renown Regional Medical Center
  • Exeter Hospital
  • Dartmouth Hitchcock Medical Center
  • Memorial Sloan Kettering Cancer Center at Basking Ridge
  • Cooper Hospital University Medical Center
  • Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
  • Saint Peter's University Hospital
  • UMDNJ - New Jersey Medical School
  • Sparta Cancer Treatment Center
  • MD Anderson Cancer Center at Cooper-Voorhees
  • University of New Mexico
  • New York Oncology Hematology PC - Albany
  • Maimonides Medical Center
  • Sands Cancer Center
  • Memorial Sloan Kettering Cancer Center Commack
  • Beth Israel Medical Center
  • Memorial Sloan-Kettering Cancer Center
  • Highland Hospital
  • University Radiation Oncology
  • University of Rochester
  • Memorial Sloan-Kettering Cancer Center Rockville Centre
  • Memorial Sloan-Kettering Cancer Center at Sleepy Hallow
  • Mission Hospital-Memorial Campus
  • University of North Carolina
  • Wayne Radiation Oncology
  • Kinston Medical Specialists PA
  • Cancer Centers of North Carolina
  • Wake Forest University Health Sciences
  • Roger Maris Cancer Center
  • Summa Akron City Hospital/Cooper Cancer Center
  • Akron General Medical Center
  • Summa Barberton Hospital
  • Mercy Medical Center
  • Geaugra Hospital
  • University of Cincinnati
  • Case Western Reserve University
  • Cleveland Clinic Cancer Center/Fairview Hospital
  • Cleveland Clinic Foundation
  • Ohio State University Medical Center
  • Mercy Cancer Center-Elyria
  • Cleveland Clinic Cancer Center Independence
  • Hillcrest Hospital Cancer Center
  • Summa Health Center at Lake Medina
  • Lake University Ireland Cancer Center
  • Southwest General Health Center Ireland Cancer Center
  • UHHS-Chagrin Highlands Medical Center
  • Saint Charles Hospital
  • Robinson Radiation Oncology
  • North Coast Cancer Care
  • Cleveland Clinic Cancer Center-Strongsville
  • Flower Hospital
  • University Pointe
  • UHHS-Westlake Medical Center
  • Cleveland Clinic Wooster Specialty Center
  • University of Oklahoma Health Sciences Center
  • Clackamas Radiation Oncology Center
  • Willamette Valley Cancer Center
  • Providence Portland Medical Center
  • Western Oncology Research Consortium
  • Providence Saint Vincent Medical Center
  • Oregon Health and Science University
  • Portland Veterans Administration Medical Center
  • Salem Hospital
  • Lehigh Valley Hospital
  • Geisinger Medical Center
  • Northeast Radiation Oncology Center
  • Pocono Medical Center
  • Adams Cancer Center
  • Cherry Tree Cancer Center
  • Saint Mary Medical and Regional Cancer Center
  • University of Pennsylvania/Abramson Cancer Center
  • Thomas Jefferson University Hospital
  • Fox Chase Cancer Center
  • Albert Einstein Medical Center
  • Reading Hospital
  • WellSpan Health-York Hospital
  • AnMed Health Cancer Center
  • Medical University of South Carolina
  • Greenville Health System Cancer Institute-Faris
  • Greenville Health System Cancer Institute/Greenville CCOP
  • Gibbs Cancer Center-Pelham
  • Spartanburg Regional Medical Center
  • Greenville Health System Cancer Institute-Spartanburg
  • Rapid City Regional Hospital
  • Sanford Cancer Center-Oncology Clinic
  • Wellmont Holston Valley Hospital and Medical Center
  • Vanderbilt-Ingram Cancer Center
  • Texas Oncology-Austin Midtown
  • Texas Oncology - Central Austin Cancer Center
  • Texas Oncology - South Austin Cancer Center
  • Texas Oncology PA - Bedford
  • University of Texas Southwestern Medical Center
  • Texas Oncology-Denton South
  • The Klabzuba Cancer Center
  • Memorial Hermann Memorial City Medical Center
  • Ben Taub General Hospital
  • M D Anderson Cancer Center
  • Texas Oncology-Seton Williamson
  • Texas Oncology - Round Rock Cancer Center
  • Cancer Care Centers of South Texas- Northeast
  • University of Texas Health Science Center at San Antonio
  • Texas Cancer Center-Sherman
  • Texas Oncology Cancer Center Sugar Land
  • Texas Oncology-Wichita Falls Texoma Cancer Center
  • Intermountain Medical Center
  • Dixie Medical Center Regional Cancer Center
  • Utah Cancer Specialists-Salt Lake City
  • Huntsman Cancer Institute/University of Utah
  • LDS Hospital
  • University of Virginia
  • Sentara Cancer Institute at Sentara CarePlex Hospital
  • Sentara Hospitals
  • Hunter Holmes McGuire Veterans Administration Medical Center
  • Virginia Commonwealth University
  • Sentara Virginia Beach General Hospital
  • Harrison Medical Center
  • Tri-Cities Cancer Center
  • Skagit Valley Hospital
  • University of Washington Medical Center
  • Cancer Care Northwest - Spokane South
  • Cancer Care Northwest-North Spokane
  • Northwest CCOP
  • PeaceHealth Southwest Medical Center
  • Compass Oncology Vancouver
  • Wenatchee Valley Medical Center
  • West Virginia University Healthcare
  • Wheeling Hospital
  • Langlade Hospital and Cancer Center
  • Fox Valley Hematology and Oncology
  • Saint Vincent Hospital
  • Gundersen Lutheran
  • University of Wisconsin Hospital and Clinics
  • Bay Area Medical Center
  • Froedtert and the Medical College of Wisconsin
  • Clement J. Zablocki VA Medical Center
  • Door County Cancer Center
  • Aspirus Regional Cancer Center
  • Cross Cancer Institute
  • CancerCare Manitoba
  • Doctor H. Bliss Murphy Cancer Centre
  • London Regional Cancer Program
  • Ottawa Health Research Institute-General Division
  • Health Sciences North
  • University Health Network-Princess Margaret Hospital
  • CHUM - Hopital Notre-Dame
  • McGill University Department of Oncology
  • CHUQ - Pavilion Hotel-Dieu de Quebec
  • Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
  • Allan Blair Cancer Centre
  • Chinese University of Hong Kong-Prince of Wales Hospital
  • King Faisal Specialist Hospital and Research Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm I: Intensity-Modulated Radiotherapy

Arm II: IMRT plus cetuximab

Arm Description

Patients undergo intensity-modulated radiotherapy (IMRT) once daily 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.

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.

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

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
Other acute adverse events (≤ 90 days from start of radiotherapy [RT]) according to CTCAE, v. 4
Other late adverse events (> 90 days from start of RT) according to CTCAE, v. 4
Disease-free survival
Loco-regional control
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
Xerostomia as measured by University of Michigan Xerostomia-Related Quality of Life Scale (XeQOLS) at baseline and at 3, 12, and 24 months
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
Skin toxicity as measured by the Dermatology Life Quality Index (DLQI) at baseline and at 3, 12, and 24 months

Full Information

First Posted
August 8, 2009
Last Updated
September 6, 2023
Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI), NRG Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT00956007
Brief Title
Radiation Therapy With or Without Cetuximab in Treating Patients Who Have Undergone Surgery for Locally Advanced Head and Neck Cancer
Official Title
A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally-Advanced Resected Head and Neck Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2009 (Actual)
Primary Completion Date
September 5, 2023 (Actual)
Study Completion Date
August 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI), NRG Oncology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
703 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I: Intensity-Modulated Radiotherapy
Arm Type
Active Comparator
Arm Description
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 Title
Arm II: IMRT plus cetuximab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
cetuximab
Intervention Description
Given IV
Intervention Type
Radiation
Intervention Name(s)
intensity-modulated radiation therapy
Intervention Description
Patients undergo radiotherapy.
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
From randomization to date of death or last follow-up. Analysis occurs after 372 events have been reported.
Secondary Outcome Measure Information:
Title
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.
Title
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.
Title
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.
Title
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.
Title
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.
Title
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.
Title
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.
Title
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.
Title
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.

10. Eligibility

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

12. IPD Sharing Statement

Learn more about this trial

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

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