Radiation Therapy With Cisplatin, Docetaxel, or Cetuximab After Surgery in Treating Patients With Stage III-IV Squamous Cell Head and Neck Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT01810913
First received: March 12, 2013
Last updated: March 14, 2016
Last verified: March 2016
  Purpose
This randomized phase II/III trial studies how well radiation therapy works when given together with cisplatin compared to docetaxel or cetuximab and docetaxel after surgery in treating patients with stage III-IV squamous cell head and neck cancer. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or transmit tumor killing molecules to them. It is not yet known whether radiation therapy is more effective when given with cisplatin, docetaxel, or cetuximab and docetaxel.

Condition Intervention Phase
Stage III Squamous Cell Carcinoma of the Hypopharynx
Stage III Squamous Cell Carcinoma of the Larynx
Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage III Squamous Cell Carcinoma of the Oropharynx
Stage III Verrucous Carcinoma of the Larynx
Stage III Verrucous Carcinoma of the Oral Cavity
Stage IV Squamous Cell Carcinoma of the Hypopharynx
Stage IVA Squamous Cell Carcinoma of the Larynx
Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage IVA Squamous Cell Carcinoma of the Oropharynx
Stage IVA Verrucous Carcinoma of the Larynx
Stage IVA Verrucous Carcinoma of the Oral Cavity
Stage IVB Squamous Cell Carcinoma of the Larynx
Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage IVB Squamous Cell Carcinoma of the Oropharynx
Stage IVB Verrucous Carcinoma of the Larynx
Stage IVB Verrucous Carcinoma of the Oral Cavity
Tongue Cancer
Drug: cisplatin
Drug: docetaxel
Biological: cetuximab
Other: laboratory biomarker analysis
Procedure: quality-of-life assessment
Radiation: intensity-modulated radiation therapy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II/III Trial of Surgery and Postoperative Radiation Delivered With Concurrent Cisplatin Versus Docetaxel Versus Docetaxel and Cetuximab for High-Risk Squamous Cell Cancer of the Head and Neck

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Disease-free survival (DFS) (Phase II) [ Time Frame: From randomization to date of failure (local, regional or distant progression or death) or last follow-up. Analysis occurs after 56 failures have been reported for each pairwise comparison. ] [ Designated as safety issue: No ]
    Estimated using the Kaplan-Meier method for each arm. Their distributions will be compared between treatment arms with a one-sided log rank test.

  • Overall survival (OS) (Phase III) [ Time Frame: From randomization to date of failure (death) or last follow-up. Analysis occurs after 183 failures have been reported. ] [ Designated as safety issue: No ]
    Estimated using the Kaplan-Meier method for each arm. Their distributions will be compared between treatment arms with a one-sided log rank test.


Secondary Outcome Measures:
  • Local-regional failure (LRF) [ Time Frame: From randomization to date of failure (local or regional progression) or distant progression or death or last follow-up. Analysis occurs at hte same time as the primary outcome. ] [ Designated as safety issue: No ]
    The cumulative incidence method will be used to estimate LRF and DM rates. Multivariate analysis will be performed using the Cox proportional hazards model.

  • Distant metastasis (DM) [ Time Frame: From randomization to date of failure (distant progression) or local or regional progression or death or last follow-up. Analysis occurs at the same time as the primary outcome. ] [ Designated as safety issue: No ]
    The cumulative incidence method will be used to estimate LRF and DM rates. Multivariate analysis will be performed using the Cox proportional hazards model.

  • Patterns of cancer failure (local, regional, distant) [ Time Frame: From randomization to date of 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 ]
  • Acute toxicity profiles during and at completion of treatment, graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0 [ Time Frame: Up to 7 weeks ] [ Designated as safety issue: Yes ]
    These rates will be estimated using a binomial distribution along with their associated 95% confidence intervals and will be compared using Fisher's exact test between the treatment arms.

  • Late toxicity profiles, graded according to the NCI CTCAE version 4.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
    These rates will be estimated using a binomial distribution along with their associated 95% confidence intervals and will be compared using Fisher's exact test between the treatment arms.

  • Functional Assessment of Cancer Therapy-Head & Neck (FACT-H&N) scores [ Time Frame: Up to 12 months after completion of RT ] [ Designated as safety issue: No ]
    The effect of acute mucosal toxicity on swallowing dysfunction and global QOL will be modeled using general linear regression. Binary outcomes will be compared using Fisher's Exact test and modeled using logistic regression. The mean change from completion of chemoradiation at each time point will be summarized using mean and standard deviations for each arm. Overall score and mean change from completion of chemoradiation will be compared between the arms using a two sample t test. If data normality assumptions are not met, the Wilcoxon rank sum test will be used to test the hypothesis. Mean change from completion of chemoradiation will be tested using an omnibus F test followed by individual comparisons of change scores at different time points within each treatment group.

  • MD Anderson Symptom Inventory - Head & Neck (MDASI-HN) scores [ Time Frame: Up to 24 months after completion of RT ] [ Designated as safety issue: No ]
    The effect of acute mucosal toxicity on swallowing dysfunction and global QOL will be modeled using general linear regression. Binary outcomes will be compared using Fisher's Exact test and modeled using logistic regression. The mean change from completion of chemoradiation at each time point will be summarized using mean and standard deviations for each arm. Overall score and mean change from completion of chemoradiation will be compared between the arms using a two sample t test. If data normality assumptions are not met, the Wilcoxon rank sum test will be used to test the hypothesis. Mean change from completion of chemoradiation will be tested using an omnibus F test followed by individual comparisons of change scores at different time points within each treatment group.

  • MD Anderson Dysphagia Inventory (MDADI) scores [ Time Frame: Up to 24 months after completion of RT ] [ Designated as safety issue: No ]
    The effect of acute mucosal toxicity on swallowing dysfunction and global QOL will be modeled using general linear regression. Binary outcomes will be compared using Fisher's Exact test and modeled using logistic regression. The mean change from completion of chemoradiation at each time point will be summarized using mean and standard deviations for each arm. Overall score and mean change from completion of chemoradiation will be compared between the arms using a two sample t test. If data normality assumptions are not met, the Wilcoxon rank sum test will be used to test the hypothesis. Mean change from completion of chemoradiation will be tested using an omnibus F test followed by individual comparisons of change scores at different time points within each treatment group.

  • EuroQol (EQ-5D) scores [ Time Frame: Up to 24 months after completion of RT ] [ Designated as safety issue: No ]
    The effect of acute mucosal toxicity on swallowing dysfunction and global QOL will be modeled using general linear regression. Binary outcomes will be compared using Fisher's Exact test and modeled using logistic regression. The mean change from completion of chemoradiation at each time point will be summarized using mean and standard deviations for each arm. Overall score and mean change from completion of chemoradiation will be compared between the arms using a two sample t test. If data normality assumptions are not met, the Wilcoxon rank sum test will be used to test the hypothesis. Mean change from completion of chemoradiation will be tested using an omnibus F test followed by individual comparisons of change scores at different time points within each treatment group.

  • Quality adjusted life year (QALY) [ Time Frame: From randomization to date of death or last follow-up. ] [ Designated as safety issue: No ]
    Quality-adjusted survival will be compared using a two-sample independent t test. If data normality assumptions are not met, the Wilcoxon rank sum test will be used to test the hypothesis.

  • Translational research analysis [ Time Frame: From randomization to date of death or last follow-up. ] [ Designated as safety issue: No ]

Estimated Enrollment: 675
Study Start Date: March 2013
Estimated Primary Completion Date: May 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 (IMRT, cisplatin)
Patients undergo IMRT QD five days a week and receive cisplatin IV over 1-2 hours once weekly for 6 weeks.
Drug: cisplatin
Given IV
Other Names:
  • CACP
  • CDDP
  • CPDD
  • DDP
Other: laboratory biomarker analysis
Correlative studies
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Radiation: intensity-modulated radiation therapy
Undergo IMRT
Other Name: IMRT
Experimental: Arm 2 (IMRT, docetaxel)
Patients undergo IMRT as in Arm I and receive docetaxel IV once weekly for 6 weeks.
Drug: docetaxel
Given IV
Other Names:
  • RP 56976
  • Taxotere
  • TXT
Other: laboratory biomarker analysis
Correlative studies
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Radiation: intensity-modulated radiation therapy
Undergo IMRT
Other Name: IMRT
Experimental: Arm 3 (IMRT, docetaxel, cetuximab)
Patients receive cetuximab IV over 120 minutes on week 1 and over 60 minutes once weekly on weeks 2-7. Patients undergo IMRT as in Arm I and receive docetaxel once weekly for 6 weeks.
Drug: docetaxel
Given IV
Other Names:
  • RP 56976
  • Taxotere
  • TXT
Biological: cetuximab
Given IV
Other Names:
  • C225
  • C225 monoclonal antibody
  • IMC-C225
  • MOAB C225
  • monoclonal antibody C225
Other: laboratory biomarker analysis
Correlative studies
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Radiation: intensity-modulated radiation therapy
Undergo IMRT
Other Name: IMRT

Detailed Description:

PRIMARY OBJECTIVES:

I. To select the better experimental arm to improve disease-free survival (DFS) over the control arm of radiation and cisplatin. (Phase II) II. To determine whether the selected experimental arm will improve overall survival (OS) over the control arm of radiation and cisplatin. (Phase III)

SECONDARY OBJECTIVES:

I. To improve local-regional disease control. II. To compare distant metastasis. III. To compare patterns of cancer failure (local, regional, distant) and correlate with radiation dose and technique.

IV. To compare acute toxicity profiles during radiation therapy (RT) and at completion of treatment.

V. To compare late toxicity profiles at 1, 3, and 5 years after treatment. VI. To compare overall quality of life. VII. To compare patient-reported outcome. VIII. To compare swallowing function at 1 and 2 years. IX. To investigate associations between acute mucosal toxicity, swallowing function, and quality of life (QOL).

X. To compare quality adjusted life years (QALY). XI. To investigate associations between late toxicity (dysphagia) and QALY. XII. To determine whether specific molecular profiles are associated with clinical outcomes.

OUTLINE: Patients are randomized to 1 of 3 treatment groups.

ARM 1: Patients undergo intensity modulated radiation therapy (IMRT) once daily (QD) five days a week and receive cisplatin intravenously (IV) over 1-2 hours once weekly for 6 weeks.

ARM 2: Patients undergo IMRT as in Arm I and receive docetaxel IV once weekly for 6 weeks.

ARM 3: Patients receive cetuximab IV over 120 minutes on week 1 and over 60 minutes once weekly on weeks 2-7. Patients undergo IMRT as in Arm I and receive docetaxel once weekly for 6 weeks.

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   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically (histologically or cytologically) proven diagnosis of head and neck squamous cell carcinoma (HNSCC) involving the oral cavity (excluding lips), oropharynx (p16 negative), larynx, or hypopharynx within 63 days of registration
  • Patients must have undergone gross total surgical resection of high-risk oral cavity, oropharynx (p16 negative), larynx, or hypopharynx within 63 days prior to registration
  • Patients must have at least 1 of the following high-risk pathologic features: extracapsular nodal extension or invasive cancer at the primary tumor resection margin (tumor or ink)
  • Pathologic stage III or IV head and neck squamous cell carcinoma (HNSCC), including no distant metastases, based upon the following minimum diagnostic workup:

    • General history and physical examination by a radiation oncologist and/or medical oncologist within 84 days prior to registration;
    • Examination by an ear nose throat (ENT) or head & neck surgeon prior to surgery; a laryngopharyngoscopy (mirror and/or fiber optic and/or direct procedure), if appropriate is recommended but not required. Intra-operative examination is acceptable documentation.
    • Pre-op Imaging of the head and neck: A neck computed tomography (CT) (with contrast) or CT/positron emission tomography (PET) (with contrast) and/or an magnetic resonance imaging (MRI) of the neck (T1 with Gadolinium and T2) within 84 days prior to surgery; note: this imaging data (diagnostic pre-operative scan showing gross disease) is to be submitted in Digital Imaging and Communications in Medicine (DICOM) format via TRIAD; the report is to be uploaded into Rave
    • Chest CT scan (with or without contrast) or CT/PET that includes the chest (with or without contrast) either within 84 days prior to surgery or within 120 days prior to registration; NOTE: If the CT/PET with or without contrast is done within 84 days prior to surgery, if fulfills the chest imaging requirement.
  • Zubrod performance status of 0-1 within 14 days prior to registration
  • Absolute granulocyte count (AGC) >= 1,500 cells/mm^3
  • Platelets >= 100,000 cells/mm^3
  • Hemoglobin >= 8.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)
  • Total bilirubin < 2 x institutional upper limit of normal (ULN) within 14 days prior to registration
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x institutional ULN within 14 days prior to registration
  • Serum creatinine institutional ULN within 14 days prior to registration or; creatinine clearance (CC) >= 50 ml/min within 14 days prior to registration determined by 24-hour collection or estimated by Cockcroft-Gault formula
  • Negative serum or urine pregnancy test within 14 days prior to registration for women of childbearing potential
  • The following assessments are required within 14 days prior to registration: sodium (Na), potassium (K), chloride (Cl), glucose, calcium (Ca), magnesium (Mg), and albumin; Note: Patients with an initial magnesium < 0.5 mmol/L (1.2 mg/dl) may receive corrective magnesium supplementation but should continue to receive either prophylactic weekly infusion of magnesium and/or oral magnesium supplementation (eg, magnesium oxide) at the investigator's discretion
  • Patients with feeding tubes are eligible for the study
  • Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control
  • Patient must provide study specific informed consent prior to study entry, including consent for mandatory tissue submission for epidermal growth factor receptor (EGFR) analysis and for oropharyngeal cancer patients, human papilloma virus (HPV) analysis

Exclusion Criteria:

  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1095 days (3 years); noninvasive cancers (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible) are permitted even if diagnosed and treated < 3 years ago
  • Patients with simultaneous primaries or bilateral tumors are excluded, with the exception of patients with bilateral tonsil cancers or patients with T1-2, N0, M0 resected differentiated thyroid carcinoma, who are eligible
  • Prior systemic chemotherapy or anti-epidermal growth factor (EGF) therapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • Severe, active co-morbidity, defined as follows:

    • Unstable angina and/or congestive heart failure requiring hospitalization within 6 months prior to registration
    • Transmural myocardial infarction within 6 months prior to registration
    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
    • Idiopathic pulmonary fibrosis or other severe interstitial lung disease that requires oxygen therapy or is thought to require oxygen therapy within 1 year prior to registration
    • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for coagulation parameters are not required for entry into this protocol
    • Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease and Control (CDC) definition; note: HIV testing is not required for entry into this protocol; the need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive; protocol-specific requirements may also exclude immuno-compromised patients
  • Grade 3-4 electrolyte abnormalities (Common Terminology Criteria for Adverse Events [CTCAE], v. 4):
  • Serum calcium (ionized or adjusted for albumin) < 7 mg/dl (1.75 mmol/L) or > 12.5 mg/dl (> 3.1 mmol/L) despite intervention to normalize levels
  • Glucose < 40 mg/dl (< 2.2 mmol/L) or > 250 mg/dl (> 14mmol/L)
  • Magnesium < 0.9 mg/dl (< 0.4 mmol/L) or > 3 mg/dl (> 1.23 mmol/L) despite intervention to normalize levels
  • Potassium < 3.0 mmol/L or > 6 mmol/L despite intervention to normalize levels
  • Sodium < 130 mmol/L or > 155 mmol/L despite intervention to normalize levels
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic
  • Prior allergic reaction to cetuximab
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01810913

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
The Kirklin Clinic at Acton Road
Birmingham, Alabama, United States, 35243
United States, Arizona
The University of Arizona Medical Center-University Campus
Tucson, Arizona, United States, 85724
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, United States, 95603
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States, 91505
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, United States, 95682
Mercy San Juan Medical Center
Carmichael, California, United States, 95608
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Memorial Medical Center
Modesto, California, United States, 95355
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Stanford Cancer Institute
Palo Alto, California, United States, 94304
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, United States, 95661
Sutter General Hospital
Sacramento, California, United States, 95816
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Saint Helena Hospital
Saint Helena, California, United States, 94574
UCSF Medical Center-Mount Zion
San Francisco, California, United States, 94115
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Vacaville, California, United States, 95687
United States, Colorado
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, United States, 80304
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States, 80907
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, United States, 80120
Longmont United Hospital
Longmont, Colorado, United States, 80501
McKee Medical Center
Loveland, Colorado, United States, 80539
Parker Adventist Hospital
Parker, Colorado, United States, 80138
United States, Connecticut
University of Connecticut
Farmington, Connecticut, United States, 06030
Yale University
New Haven, Connecticut, United States, 06520
United States, Delaware
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718
United States, Florida
University of Miami Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States, 33442
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
UF Cancer Center at Orlando Health
Orlando, Florida, United States, 32806
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
Emory University/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Georgia Regents University Medical Center
Augusta, Georgia, United States, 30912
Memorial University Medical Center
Savannah, Georgia, United States, 31404
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, United States, 31405
United States, Hawaii
Queen's Medical Center
Honolulu, Hawaii, United States, 96813
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, United States, 96817
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, United States, 60612-3785
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Crossroads Cancer Center
Effingham, Illinois, United States, 62401
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States, 60201
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, United States, 60026
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois, United States, 60035
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453-2699
OSF Saint Francis Medical Center Radiation Oncology Service at the Central Illinois Comprehensive CC
Peoria, Illinois, United States, 61615-7827
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
SwedishAmerican Regional Cancer Center/ACT
Rockford, Illinois, United States, 61114
Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Radiation Oncology Associates PC
Fort Wayne, Indiana, United States, 46804
Parkview Hospital Randallia
Fort Wayne, Indiana, United States, 46805
IU Health Goshen Center for Cancer Care
Goshen, Indiana, United States, 46526
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
IU Health Methodist Hospital
Indianapolis, Indiana, United States, 46202
IU Health Central Indiana Cancer Centers-East
Indianapolis, Indiana, United States, 46219
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, United States, 46545
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Northern Indiana Cancer Research Consortium CCOP
South Bend, Indiana, United States, 46628
United States, Iowa
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, United States, 50010
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
United States, Kansas
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
Olathe Medical Center
Olathe, Kansas, United States, 66061
Kansas City Cancer Centers-Southwest
Overland Park, Kansas, United States, 66210
Salina Regional Health Center
Salina, Kansas, United States, 67401
United States, Kentucky
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States, 40536
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States, 40202
United States, Louisiana
Tulane University Health Sciences Center
New Orleans, Louisiana, United States, 70112
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States, 70121
United States, Maryland
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
Holy Cross Hospital
Silver Spring, Maryland, United States, 20910
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, Michigan
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Henry Ford Hospital
Detroit, Michigan, United States, 48202
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Saint Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Henry Ford Medical Center - West Bloomfield
West Bloomfield, Michigan, United States, 48322
United States, Minnesota
Miller-Dwan Hospital
Duluth, Minnesota, United States, 55805
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
Cape Radiation Oncology
Cape Girardeau, Missouri, United States, 63703
Saint Francis Medical Center
Cape Girardeau, Missouri, United States, 63703
University of Missouri - Ellis Fischel
Columbia, Missouri, United States, 65212
North Kansas City Hospital
Kansas City, Missouri, United States, 64116
Kansas City Cancer Center - South
Kansas City, Missouri, United States, 64131
Kansas City Cancer Centers - North
Kansas City, Missouri, United States, 64154
Kansas City Cancer Center-Lee's Summit
Lee's Summit, Missouri, United States, 64064
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Siteman Cancer Center-South County
Saint Louis, Missouri, United States, 63129
Missouri Baptist Medical Center
Saint Louis, Missouri, United States, 63131
Barnes-Jewish West County Hospital
Saint Louis, Missouri, United States, 63141
Mercy Hospital Saint Louis
Saint Louis, Missouri, United States, 63141
Siteman Cancer Center - Saint Peters
Saint Peters, Missouri, United States, 63376
Mercy Hospital Springfield
Springfield, Missouri, United States, 65804
CoxHealth South Hospital
Springfield, Missouri, United States, 65807
United States, Nebraska
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
United States, New Jersey
Memorial Sloan Kettering Cancer Center at Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Virtua Memorial
Mount Holly, New Jersey, United States, 08060
Sparta Cancer Treatment Center
Sparta, New Jersey, United States, 07871
Virtua West Jersey Hospital Voorhees
Voorhees, New Jersey, United States, 08043
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87102
New Mexico Oncology Hematology Consultants
Albuquerque, New Mexico, United States, 87109
United States, New York
The New York Methodist Hospital
Brooklyn, New York, United States, 11215
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Sands Cancer Center
Canandiaqua, New York, United States, 14424
Memorial Sloan Kettering Cancer Center Commack
Commack, New York, United States, 11725
Arnot Ogden Medical Center/Falck Cancer Center
Elmira, New York, United States, 14905
Beth Israel Medical Center
New York, New York, United States, 10003
Columbia University Medical Center
New York, New York, United States, 10032
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Highland Hospital
Rochester, New York, United States, 14620
University Radiation Oncology
Rochester, New York, United States, 14626
University of Rochester
Rochester, New York, United States, 14642
Memorial Sloan-Kettering Cancer Center Rockville Centre
Rockville Centre, New York, United States, 11570
Memorial Sloan-Kettering Cancer Center Sleepy Hollow
Sleepy Hollow, New York, United States, 10591
State University of New York Upstate Medical University
Syracuse, New York, United States, 13210
Memorial Sloan-Kettering Cancer Center West Harrison
West Harrison, New York, United States, 10604
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
East Carolina University
Greenville, North Carolina, United States, 27858
Kinston Medical Specialists PA
Kinston, North Carolina, United States, 28501
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Akron General Medical Center
Akron, Ohio, United States, 44307
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, United States, 44122
Geaugra Hospital
Chardon, Ohio, United States, 44024
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States, 44111
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Mercy Cancer Center-Elyria
Elyria, Ohio, United States, 44035
Cleveland Clinic Cancer Center Independence
Independence, Ohio, United States, 44131
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, United States, 44124
Lake University Ireland Cancer Center
Mentor, Ohio, United States, 44060
Southwest General Health Center Ireland Cancer Center
Middleburg Heights, Ohio, United States, 44130
University Hospitals Parma Medical Center
Parma, Ohio, United States, 44129
Ireland Cancer Center at Firelands Regional Medical Center
Sandusky, Ohio, United States, 44870
North Coast Cancer Care
Sandusky, Ohio, United States, 44870
Cleveland Clinic Cancer Center Strongsville
Strongsville, Ohio, United States, 44136
University Pointe
West Chester, Ohio, United States, 45069
UHHS-Westlake Medical Center
Westlake, Ohio, United States, 44145
Cleveland Clinic Wooster Specialty Center
Wooster, Ohio, United States, 44691
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States, 97015
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Providence Saint Vincent Medical Center
Portland, Oregon, United States, 97225
United States, Pennsylvania
UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania, United States, 15009
UPMC Cancer Center at Jefferson Regional Medical Center
Clairton, Pennsylvania, United States, 15025
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, United States, 15601
PinnacleHealth Cancer Center-Community Campus
Harrisburg, Pennsylvania, United States, 17109
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
UPMC Cancer Center at UPMC McKeesport
McKeesport, Pennsylvania, United States, 15132
UPMC-Coraopolis/Heritage Valley Radiation Oncology
Moon Township, Pennsylvania, United States, 15108
UPMC Cancer Center-Natrona Heights
Natrona Heights, Pennsylvania, United States, 15065
Jameson Health System North Campus
New Castle, Pennsylvania, United States, 16105
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
UPMC-Saint Margaret
Pittsburgh, Pennsylvania, United States, 15215
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, United States, 15232
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania, United States, 15237
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania, United States, 15243
UPMC Washington Hospital Radiation Oncology
Washington, Pennsylvania, United States, 15301
Reading Hospital
West Reading, Pennsylvania, United States, 19611
United States, South Carolina
AnMed Health Cancer Center
Anderson, South Carolina, United States, 29621
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, United States, 29605
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina, United States, 29615
Greenville Health System Cancer Institute-Greer
Greer, South Carolina, United States, 29650
Gibbs Cancer Center-Pelham
Greer, South Carolina, United States, 29651
Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina, United States, 29672
Spartanburg Medical Center
Spartanburg, South Carolina, United States, 29303
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, United States, 29307
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
United States, Texas
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0565
M D Anderson Cancer Center
Houston, Texas, United States, 77030
UTMB Cancer Center at Victory Lakes
League City, Texas, United States, 77573
Covenant Medical Center-Lakeside
Lubbock, Texas, United States, 79410
United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84157
Dixie Medical Center Regional Cancer Center
Saint George, Utah, United States, 84770
Utah Cancer Specialists-Salt Lake City
Salt Lake City, Utah, United States, 84106
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
United States, Virginia
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Sentara Cancer Institute at Sentara CarePlex Hospital
Hampton, Virginia, United States, 23666
Sentara Hospitals
Norfolk, Virginia, United States, 23507
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States, 23298
Sentara Virginia Beach General Hospital
Virginia Beach, Virginia, United States, 23454
United States, Washington
Saint Francis Hospital
Federal Way, Washington, United States, 98003
Tri-Cities Cancer Center
Kennewick, Washington, United States, 99336
Saint John Medical Center
Longview, Washington, United States, 98632
Skagit Valley Hospital Regional Cancer Care Center
Mount Vernon, Washington, United States, 98273
University of Washington Medical Center
Seattle, Washington, United States, 98195
Spokane Valley Cancer Center-Mayfair
Spokane, Washington, United States, 99208
Wenatchee Valley Hospital and Clinics
Wenatchee, Washington, United States, 98801
United States, West Virginia
West Virginia University Healthcare
Morgantown, West Virginia, United States, 26506
Wheeling Hospital/Schiffler Cancer Center
Wheeling, West Virginia, United States, 26003
United States, Wisconsin
Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301
Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, United States, 54601
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Door County Cancer Center
Sturgeon Bay, Wisconsin, United States, 54235-1495
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
China, Hong Kong
Chinese University of Hong Kong-Prince of Wales Hospital
Shatin, Hong Kong, China, OX1 3UJ
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
NRG Oncology
Investigators
Principal Investigator: Paul Harari Radiation Therapy Oncology Group
  More Information

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT01810913     History of Changes
Other Study ID Numbers: RTOG 1216  NCI-2013-00500  U10CA021661 
Study First Received: March 12, 2013
Last Updated: March 14, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Laryngeal Diseases
Laryngeal Neoplasms
Oropharyngeal Neoplasms
Carcinoma, Verrucous
Tongue Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Respiratory Tract Neoplasms
Pharyngeal Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Mouth Neoplasms
Mouth Diseases
Tongue Diseases
Docetaxel
Cisplatin
Cetuximab
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 25, 2016