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

This study is currently recruiting participants.
Verified December 2013 by Radiation Therapy Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00956007
First received: August 8, 2009
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Head and Neck Cancer
Biological: cetuximab
Radiation: intensity-modulated radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Overall survival [ Time Frame: From randomization to date of death or last follow-up. Analysis occurs after 372 events have been reported. ] [ Designated as safety issue: No ]

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 [ Time Frame: From start of treatment to 2 years after end of treatment. ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 700
Study Start Date: November 2009
Estimated Primary Completion Date: August 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Hide Detailed Description

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 < 3.5 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00956007

  Hide Study Locations
Locations
United States, Alabama
UAB Comprehensive Cancer Center Recruiting
Birmingham, Alabama, United States, 35294
Contact: Clinical Trials Office - UAB Comprehensive Cancer Center    205-934-0309      
United States, Arizona
Arizona Oncology - Tucson Recruiting
Tucson, Arizona, United States, 85704
Contact: Vivek S. Kavadi    520-797-4468      
United States, California
Auburn Radiation Oncology Recruiting
Auburn, California, United States, 95603
Contact: Christopher Jones, MD    916-646-6600      
Radiation Oncology Centers - Cameron Park Recruiting
Cameron Park, California, United States, 95682
Contact: Christopher Jones, MD    916-646-6600      
Mercy Cancer Center at Mercy San Juan Medical Center Recruiting
Carmichael, California, United States, 95608
Contact: Christopher Jones, MD    916-646-6600      
City of Hope Comprehensive Cancer Center Recruiting
Duarte, California, United States, 91010-3000
Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen    800-826-4673    becomingapatient@coh.org   
Rebecca and John Moores UCSD Cancer Center Recruiting
La Jolla, California, United States, 92093-0658
Contact: Clinical Trials Office - Rebecca and John Moores UCSD Cancer    858-822-5354    cancercto@ucsd.edu   
Memorial Medical Center Recruiting
Modesto, California, United States, 95355
Contact: Clinical Trials Office - Memorial Medical Center    209-572-7116      
Radiation Oncology Center - Roseville Recruiting
Roseville, California, United States, 95661
Contact: Christopher Jones, MD    916-646-6600      
Radiological Associates of Sacramento Medical Group, Incorporated Recruiting
Sacramento, California, United States, 95815
Contact: Christopher Jones, MD    916-646-6600      
Mercy General Hospital Recruiting
Sacramento, California, United States, 95819
Contact: Christopher Jones, MD    916-646-6600      
University of California Davis Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Clinical Trials Office - University of California Davis Cancer    916-734-3089      
Saint Helena Hospital Recruiting
Saint Helena, California, United States, 94574
Contact: David J. Tate    707-963-3611      
UCSF Helen Diller Family Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94115
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi    877-827-3222      
Solano Radiation Oncology Center Recruiting
Vacaville, California, United States, 95687
Contact: Christopher Jones, MD    916-646-6600      
United States, Colorado
Rocky Mountain Cancer Centers - Aurora Recruiting
Aurora, Colorado, United States, 80012
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
University of Colorado Cancer Center at UC Health Sciences Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Clinical Trials Office - University of Colorado Cancer Center    720-848-0650      
Penrose Cancer Center at Penrose Hospital Recruiting
Colorado Springs, Colorado, United States, 80933
Contact: Clinical Trials Office - Penrose Cancer Center    719-776-5275      
Porter Adventist Hospital Recruiting
Denver, Colorado, United States, 80210
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
United States, Connecticut
St. Vincent's Medical Center Recruiting
Bridgeport, Connecticut, United States, 06606
Contact: Christopher M. Iannuzzi    203-576-6000      
Yale Cancer Center Recruiting
New Haven, Connecticut, United States, 06520-8028
Contact: Clinical Trials Office - Yale Cancer Center    203-785-5702      
William W. Backus Hospital Recruiting
Norwich, Connecticut, United States, 06360
Contact: Dennis E. Slater, MD    860-886-8362      
United States, Delaware
CCOP - Christiana Care Health Services Recruiting
Newark, Delaware, United States, 19713
Contact: Clinical Trial Office - CCOP - Christiana Care Health Services    302-623-4450      
United States, Florida
Florida Hospital Cancer Institute at Florida Hospital Orlando Recruiting
Orlando, Florida, United States, 32803-1273
Contact: Clinical Trials Office - Florida Hospital Cancer Institute    407-303-5623      
United States, Georgia
Winship Cancer Institute of Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Clinical Trials Office - Winship Cancer Institute    404-778-1900      
Emory Crawford Long Hospital Recruiting
Atlanta, Georgia, United States, 30308
Contact: Jonathan J. Beitler    404-686-4411      
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler Recruiting
Savannah, Georgia, United States, 31405
Contact: John A. Pablo    912-819-6000      
United States, Hawaii
Cancer Research Center of Hawaii Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Clinical Trials Office - Cancer Research Center of Hawaii    808-586-2979      
Hawaii Medical Center - East Recruiting
Honolulu, Hawaii, United States, 96817
Contact: Paul A. DeMare, MD, FACR    808-547-4771      
Queen's Cancer Institute at Queen's Medical Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Paul A. DeMare, MD, FACR    808-547-4771      
United States, Idaho
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center Recruiting
Boise, Idaho, United States, 83706
Contact: Clinical Trials Office - Saint Alphonsus Cancer Care Center    208-367-7954      
United States, Illinois
Ingalls Cancer Care Center at Ingalls Memorial Hospital Recruiting
Harvey, Illinois, United States, 60426
Contact: Clinical Trials Office - Ingalls Cancer Care Center at Ingalls    708-915-4673      
Cardinal Bernardin Cancer Center at Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Clinical Trials Office - Cardinal Bernardin Cancer Center    708-226-4357      
Cancer Institute at St. John's Hospital Recruiting
Springfield, Illinois, United States, 62702
Contact: Cathy L. Clausen, MD    765-646-8358      
CCOP - Carle Cancer Center Recruiting
Urbana, Illinois, United States, 61801
Contact: Clinical Trials Office - CCOP - Carle Cancer Center    800-446-5532      
United States, Indiana
Radiation Oncology Associates Southwest Recruiting
Fort Wayne, Indiana, United States, 46804
Contact: Brian K. Chang    260-436-4116      
Parkview Regional Cancer Center at Parkview Health Recruiting
Fort Wayne, Indiana, United States, 46805
Contact: Brian K. Chang    260-373-7850      
Center for Cancer Care at Goshen General Hospital Recruiting
Goshen, Indiana, United States, 46526
Contact: Clinical Trials Office - Center for Cancer Care at Goshen Gene    574-535-2858      
Community Regional Cancer Care at Community Hospital East Recruiting
Indianapolis, Indiana, United States, 46219
Contact: Shih J. Wei    317-355-5347      
Community Regional Cancer Care at Community Hospital North Recruiting
Indianapolis, Indiana, United States, 46256
Contact: Shih J. Wei    317-621-4300      
Cancer Center at Ball Memorial Hospital Recruiting
Muncie, Indiana, United States, 47303-3499
Contact: Clinical Trials Office - Cancer Center at Ball Memorial Hospit    765-281-2107      
United States, Iowa
McFarland Clinic, PC Recruiting
Ames, Iowa, United States, 50010
Contact: Clinical Trials Office - McFarland Clinic, PC    515-239-2621      
Siouxland Hematology-Oncology Associates, LLP Recruiting
Sioux City, Iowa, United States, 51101
Contact: Donald B. Wender, MD, PhD    712-252-0088      
United States, Kansas
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160-7357
Contact: Clinical Trials Office - Kansas Masonic Cancer Research Instit    913-588-4709      
United States, Kentucky
Lucille P. Markey Cancer Center at University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536-0093
Contact: Clinical Trials Office - Markey Cancer Center at University of    859-257-3379      
James Graham Brown Cancer Center at University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Shiao Y. Woo    502-562-4158      
United States, Louisiana
Tulane Cancer Center Office of Clinical Research Recruiting
Alexandria, Louisiana, United States, 71315-3198
Contact: Clinical Trials Office - Tulane Cancer Center    504-988-6121      
United States, Maine
Central Maine Comprehensive Cancer Center at Central Maine Medical Center Recruiting
Lewiston, Maine, United States, 04240
Contact: Courtney A. Jensen    207-795-2440      
United States, Massachusetts
Boston University Cancer Research Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Clinical Trials Office - Boston University Cancer Research Cen    617-638-8265      
Lahey Clinic Medical Center - Burlington Recruiting
Burlington, Massachusetts, United States, 01805
Contact: Clinical Trials Office - Lahey Clinic Medical Center - Burling    781-744-8027      
United States, Michigan
University of Michigan Comprehensive Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109-0942
Contact: Clinical Trials Office - University of Michigan Comprehensive    800-865-1125      
West Michigan Cancer Center Recruiting
Kalamazoo, Michigan, United States, 49007-3731
Contact: Clinical Trials Office - West Michigan Cancer Center    269-373-7458      
Seton Cancer Institute at Saint Mary's - Saginaw Recruiting
Saginaw, Michigan, United States, 48601
Contact: Clinical Trials Office - Seton Cancer Institute - Saginaw    989-776-8411      
United States, Minnesota
Mercy and Unity Cancer Center at Mercy Hospital Recruiting
Coon Rapids, Minnesota, United States, 55433
Contact: Paul Sperduto, MD, MAPP    952-442-6000      
Mercy and Unity Cancer Center at Unity Hospital Recruiting
Fridley, Minnesota, United States, 55432
Contact: Paul Sperduto, MD, MAPP    952-442-6000      
Minnesota Oncology - Maplewood Recruiting
Maplewood, Minnesota, United States, 55109
Contact: Paul Sperduto, MD, MAPP    952-442-6000      
Mayo Clinic Cancer Center Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office - All Mayo Clinic Locations    507-538-7623      
United States, Mississippi
Regional Cancer Center at Singing River Hospital Recruiting
Pascagoula, Mississippi, United States, 39581
Contact: James E. Clarkson, MD    228-374-6296      
United States, Missouri
Cancer Institute of Cape Girardeau, LLC Recruiting
Cape Girardeau, Missouri, United States, 63703
Contact: Tapan Roy, MD    573-334-2230      
Barnes-Jewish West County Hospital Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Wade L. Thorstad, MD    314-362-8516      
Missouri Baptist Cancer Center Recruiting
Saint Louis, Missouri, United States, 63131
Contact: Alan P. Lyss, MD    314-996-5514      
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Wade L. Thorstad, MD    314-362-8516      
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters Recruiting
Saint Peters, Missouri, United States, 63376
Contact: Wade L. Thorstad, MD    314-362-8516      
Hulston Cancer Center at Cox Medical Center South Recruiting
Springfield, Missouri, United States, 65807
Contact: Robert L. Carolla    417-269-5257      
United States, Nebraska
Saint Elizabeth Cancer Institute at Saint Elizabeth Regional Medical Center Recruiting
Lincoln, Nebraska, United States, 68510
Contact: Clinical Trials Office - Saint Elizabeth Cancer Institute at S    402-483-2827      
Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Weining K. Zhen, MD    402-552-3844      
Methodist Estabrook Cancer Center Recruiting
Omaha, Nebraska, United States, 68114
Contact: Tien-Shew W. Huang    402-354-5890      
United States, Nevada
Renown Institute for Cancer at Renown Regional Medical Center Recruiting
Reno, Nevada, United States, 89502
Contact: Daniel W. Weed    775-982-5050      
United States, New Hampshire
Center for Cancer Care at Exeter Hospital Recruiting
Exeter, New Hampshire, United States, 03833
Contact: Gary M. Proulx    570-882-4048      
United States, New Jersey
Memorial Sloan-Kettering Cancer Center - Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Nancy Lee, MD    212-639-3341      
Saint Peter's University Hospital Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Gopal R. Desai    732-745-8600      
Frederick R. and Betty M. Smith Cancer Treatment Center Recruiting
Sparta, New Jersey, United States, 07871
Contact: Rita S. Axelrod, MD    215-955-8874      
United States, New Mexico
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87131-5636
Contact: Clinical Trials Office - University of New Mexico Cancer Cente    505-272-6972      
United States, New York
New York Oncology Hematology, PC at Albany Regional Cancer Care Recruiting
Albany, New York, United States, 12206
Contact: Vivek S. Kavadi    518-489-2607      
Sands Cancer Center Recruiting
Canandiaqua, New York, United States, 14424
Contact: Yuhchyau Chen    585-396-6161      
Memorial Sloan-Kettering Cancer Center Recruiting
Commack, New York, United States, 11725
Contact: Nancy Lee, MD    212-639-3341      
Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital Recruiting
Cooperstown, New York, United States, 13326
Contact: Timothy Campbell    607-547-3336      
Beth Israel Medical Center - Petrie Division Recruiting
New York, New York, United States, 10003-3803
Contact: Clinical Trials Office - Beth Israel Medical Center - Petrie D    212-844-6286      
James P. Wilmot Cancer Center at University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Yuhchyau Chen    585-275-5345      
Highland Hospital of Rochester Recruiting
Rochester, New York, United States, 14620
Contact: Yuhchyau Chen    585-473-2200      
University Radiation Oncology at Parkridge Hospital Recruiting
Rochester, New York, United States, 14626
Contact: Yuhchyau Chen    585-225-3989      
Memorial Sloan-Kettering Cancer Center - Rockville Centre Recruiting
Rockville Centre, New York, United States, 11570
Contact: Nancy Lee, MD    212-639-3341      
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center Recruiting
Sleepy Hollow, New York, United States, 10591
Contact: Nancy Lee, MD    212-639-3341      
United States, North Carolina
Mission Hospitals - Memorial Campus Recruiting
Asheville, North Carolina, United States, 28801
Contact: Clinical Trials Office - Mission Hospitals - Memorial Campus    828-213-4150      
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599-7295
Contact: Clinical Trials Office - Lineberger Comprehensive Cancer Cente    877-668-0683      
Contact: Clinical Trials Office    919-966-4432      
Kinston Medical Specialists Recruiting
Kinston, North Carolina, United States, 28501
Contact: Peter R. Watson, MD    252-559-2200 ext 201      
Cancer Centers of North Carolina - Raleigh Recruiting
Raleigh, North Carolina, United States, 27607
Contact: Vivek S. Kavadi    919-781-7070      
United States, Ohio
McDowell Cancer Center at Akron General Medical Center Recruiting
Akron, Ohio, United States, 44307
Contact: Mitchell L. Fromm, MD    330-344-6448      
Summa Center for Cancer Care at Akron City Hospital Recruiting
Akron, Ohio, United States, 44309-2090
Contact: Clinical Trials Office - Akron City Hospital    330-375-6101      
Barberton Citizens Hospital Recruiting
Barberton, Ohio, United States, 44203
Contact: William F. Demas, MD    330-375-3557      
Mercy Cancer Center at Mercy Medical Center Recruiting
Canton, Ohio, United States, 44708
Contact: Edward J. Walsh    330-430-2788      
Charles M. Barrett Cancer Center at University Hospital Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Kevin P. Redmond, MD    513-584-9089      
Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106-5065
Contact: Clinical Trials Office - Case Comprehensive Cancer Center    800-641-2422      
Cleveland Clinic Taussig Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente    866-223-8100      
Cleveland Clinic Cancer Center at Fairview Hospital Recruiting
Cleveland, Ohio, United States, 44111
Contact: Clinical Trials Office - Cleveland Clinic Cancer Center at Fai    216-476-9362      
MetroHealth Cancer Care Center at MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Bruce J. Averbook, MD, FACS    216-778-4795      
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210-1240
Contact: Ohio State University Cancer Clinical Trial Matching Service    866-627-7616    Jamesline@osumc.edu   
Hillcrest Cancer Center at Hillcrest Hospital Recruiting
Mayfield Heights, Ohio, United States, 44124
Contact: David J. Adelstein    440-312-4500      
Lake/University Ireland Cancer Center Recruiting
Mentor, Ohio, United States, 44060
Contact: Min Yao    440-205-5755      
Southwest General Health Center Recruiting
Middleburg Heights, Ohio, United States, 44130
Contact: Min Yao    440-816-8000      
St. Charles Mercy Hospital Recruiting
Oregon, Ohio, United States, 43616
Contact: Rex B. Mowat    419-696-7200      
Robinson Radiation Oncology Recruiting
Ravenna, Ohio, United States, 44266
Contact: Mitchell L. Fromm, MD    330-344-6448      
North Coast Cancer Care, Incorporated Recruiting
Sandusky, Ohio, United States, 44870
Contact: David J. Adelstein    419-626-9090      
Flower Hospital Cancer Center Recruiting
Sylvania, Ohio, United States, 43560
Contact: Clinical Trials Office - Flower Hospital Cancer Center    419-824-1842      
Precision Radiotherapy at University Pointe Recruiting
West Chester, Ohio, United States, 45069
Contact: Kevin P. Redmond, MD    513-584-9089      
United States, Oklahoma
Oklahoma University Cancer Institute Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Terence S. Herman    405-271-6822      
United States, Oregon
Clackamas Radiation Oncology Center Recruiting
Clackamas, Oregon, United States, 97015
Contact: Matthew C. Solhjem    503-513-3300      
Willamette Valley Cancer Center - Eugene Recruiting
Eugene, Oregon, United States, 97401
Contact: Vivek S. Kavadi    541-683-5001      
CCOP - Columbia River Oncology Program Recruiting
Portland, Oregon, United States, 97225
Contact: Matthew C. Solhjem    503-216-6260      
Legacy Good Samaritan Hospital & Comprehensive Cancer Center Recruiting
Portland, Oregon, United States, 97210
Contact: Clinical Trials Office - Legacy Good Samaritan Hospital & Com    503-413-1742      
Providence Cancer Center at Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213-2967
Contact: Clinical Trials Office - Providence Cancer Center at Providenc    503-215-6412      
Providence St. Vincent Medical Center Recruiting
Portland, Oregon, United States, 97225
Contact: Clinical Trials Office - Providence St. Vincent Medical Center    503-215-6412      
Veterans Affairs Medical Center - Portland Recruiting
Portland, Oregon, United States, 97239
Contact: Neil D. Gross    503-220-8262      
Knight Cancer Institute at Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239-3098
Contact: Clinical Trials Office - Knight Cancer Institute at Oregon Hea    503-494-1080    trials@ohsu.edu   
Salem Hospital Regional Cancer Care Services Recruiting
Salem, Oregon, United States, 97309-5014
Contact: Clinical Trials Office - Salem Hospital Regional Cancer Care S    503-561-2618      
United States, Pennsylvania
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest Recruiting
Allentown, Pennsylvania, United States, 18105
Contact: Eliot L. Friedman, MD    610-402-0512      
Dale and Frances Hughes Cancer Center at Pocono Medical Center Recruiting
East Stroudsburg, Pennsylvania, United States, 18301
Contact: Rita S. Axelrod, MD    215-955-8874      
Regional Cancer Center - Erie Recruiting
Erie, Pennsylvania, United States, 16505
Contact: Andrew T. Figura    814-838-9000      
Adams Cancer Center Recruiting
Gettysburg, Pennsylvania, United States, 17325
Contact: Amit B. Shah    717-741-8180      
Fox Chase Cancer Center - Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19111-2497
Contact: Clinical Trials Office - Fox Chase Cancer Center - Philadelphi    215-728-4790      
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19107-5541
Contact: Clinical Trials Office - Kimmel Cancer Center at Thomas Jeffer    215-955-6084      
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center Recruiting
Reading, Pennsylvania, United States, 19612-6052
Contact: Clinical Trials Office - McGlinn Family Regional Cancer Center    610-988-9323      
York Cancer Center at Apple Hill Medical Center Recruiting
York, Pennsylvania, United States, 17405
Contact: Amit B. Shah    717-741-8180      
United States, South Carolina
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Recruiting
Spartanburg, South Carolina, United States, 29303
Contact: Clinical Trials Office - Gibbs Regional Cancer Center    800-486-5941      
United States, South Dakota
Rapid City Regional Hospital Recruiting
Rapid City, South Dakota, United States, 57701
Contact: Michael J. Swartz    605-719-2360      
United States, Tennessee
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232-6838
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center    800-811-8480      
United States, Texas
Texas Oncology, PA at Harris Center HEB Recruiting
Bedford, Texas, United States, 76022
Contact: Vivek S. Kavadi    817-359-9000      
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a    866-460-4673      
Contact: Clinical Trials Office    214-648-7097      
Texas Oncology, PA at Texas Cancer Center - Denton South Recruiting
Denton, Texas, United States, 76210
Contact: Vivek S. Kavadi    940-382-1022      
Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital Recruiting
Fort Worth, Texas, United States, 76104
Contact: Vivek S. Kavadi    817-820-4820      
Memorial Hermann Hospital - Memorial City Recruiting
Houston, Texas, United States, 77024
Contact: Vivek S. Kavadi    713-242-3500      
M. D. Anderson Cancer Center at University of Texas Recruiting
Houston, Texas, United States, 77030-4009
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U    713-792-3245      
University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229-3900
Contact: Ying Li    210-567-4777      
Cancer Care Centers of South Texas - Northeast Recruiting
San Antonio, Texas, United States, 78217
Contact: Vivek S. Kavadi    210-656-7177      
Texas Oncology, PA at Texas Cancer Center - Sherman Recruiting
Sherman, Texas, United States, 75090
Contact: Vivek S. Kavadi    903-892-9455      
Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land Recruiting
Sugar Land, Texas, United States, 77479
Contact: Vivek S. Kavadi    281-277-5200      
Texas Oncology, PA - Wichita Falls Recruiting
Wichita Falls, Texas, United States, 76310
Contact: Vivek S. Kavadi    940-767-4364      
United States, Utah
Dixie Regional Medical Center - East Campus Recruiting
Saint George, Utah, United States, 84770
Contact: Clinical Trials Office - Dixie Regional Medical Center - East    435-688-4167      
Huntsman Cancer Institute at University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Clinical Trials Office - Huntsman Cancer Institute at Universi    801-581-4477    clinical.trials@hci.utah.edu   
Utah Cancer Specialists at UCS Cancer Center Recruiting
Salt Lake City, Utah, United States, 84106
Contact: Vilija N. Avizonis    801-269-0231      
United States, Virginia
Sentara Cancer Institute at Sentara Norfolk General Hospital Recruiting
Norfolk, Virginia, United States, 23507
Contact: Clinical Trials Office - Sentara Cancer Institute at Sentara N    757-388-2406      
Virginia Commonwealth University Massey Cancer Center Recruiting
Richmond, Virginia, United States, 23298-0037
Contact: Clinical Trials Office -Virginia Commonwealth University Masse    804-628-1939      
Veterans Affairs Medical Center - Richmond Recruiting
Richmond, Virginia, United States, 23249
Contact: Clinical Trials Office - Veterans Affairs Medical Center - Ric    804-675-5646      
Coastal Cancer Center at Sentara Virginia Beach General Hospital Recruiting
Virginia Beach, Virginia, United States, 23454
Contact: Scott S. Williams    757-395-8686      
United States, Washington
Cancer Care Northwest - Spokane South Recruiting
Spokane, Washington, United States, 99202
Contact: Clinical Trials Office - Cancer Care Northwest - Spokane South    509-228-1083      
CCOP - Northwest Recruiting
Tacoma, Washington, United States, 98405
Contact: Yoshio Inoue    253-403-1461      
Northwest Cancer Specialists at Vancouver Cancer Center Recruiting
Vancouver, Washington, United States, 98684
Contact: Matthew C. Solhjem    360-944-9889      
Southwest Washington Medical Center Cancer Center Recruiting
Vancouver, Washington, United States, 98664
Contact: Matthew C. Solhjem    360-514-2174      
United States, Wisconsin
Langlade Memorial Hospital Recruiting
Antigo, Wisconsin, United States, 54409
Contact: Darryl R. Barton, MD    715-847-2866      
Fox Valley Hematology and Oncology - East Grant Street Recruiting
Appleton, Wisconsin, United States, 54911-3496
Contact: Robert R. Kohl    920-749-1171      
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Recruiting
Madison, Wisconsin, United States, 53792-6164
Contact: Clinical Trials Office - University of Wisconsin Paul P. Carbo    608-262-5223      
Medical College of Wisconsin Cancer Center Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Clinical Trials Office - Medical College of Wisconsin Cancer C    414-805-4380      
Veterans Affairs Medical Center - Milwaukee Recruiting
Milwaukee, Wisconsin, United States, 53295
Contact: Elizabeth M. Gore, MD    414-805-4369      
Canada, Alberta
Cross Cancer Institute at University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Susan Chafe, MD    780-432-8518      
Canada, Newfoundland and Labrador
Doctor H. Bliss Murphy Cancer Centre Recruiting
Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
Contact: Craig M. Pochini    709-777-7589      
Canada, Nova Scotia
Nova Scotia Cancer Centre Recruiting
Halifax, Nova Scotia, Canada, B3H 1V8
Contact: Helmut Hollenhorst    902-473-6000      
Canada, Ontario
London Regional Cancer Program at London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 4L6
Contact: Nancy E. Read    519-685-8615      
Ottawa Hospital Regional Cancer Centre - General Campus Recruiting
Ottawa, Ontario, Canada, K1Y 4E9
Contact: Samy El-Sayed    613-737-7700 ext. 70209      
Northeastern Ontario Regional Cancer Centre Recruiting
Sudbury, Ontario, Canada, P3E 5J1
Contact: Adam K. Andronowski    705-522-6237      
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: John (Joon-Hyung) Kim    416-946-2811      
Canada, Quebec
Hopital Notre-Dame du CHUM Recruiting
Montreal, Quebec, Canada, H2L 4M1
Contact: Edith J. Filion    514-281-6000      
McGill Cancer Centre at McGill University Recruiting
Montreal, Quebec, Canada, H2W 1S6
Contact: George Shenouda    514-398-1444      
Canada, Saskatchewan
Allan Blair Cancer Centre at Pasqua Hospital Recruiting
Regina, Saskatchewan, Canada, S4T 7T1
Contact: Evgeny Sadikov    306-766-2203      
Hong Kong
Prince of Wales Hospital Recruiting
Shatin, Hong Kong, OX1 3UJ
Contact: Michael K.M. Kam    852-636-3337      
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: Mitchell Machtay, MD University Hospitals Seidman Cancer Center
  More Information

Additional Information:
No publications provided

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
Study First Received: August 8, 2009
Last Updated: December 16, 2013
Health Authority: United States: Food and Drug Administration

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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014