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 currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by Radiation Therapy Oncology Group
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: November 14, 2015
Last verified: November 2015
  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
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 < 3.5 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 Recruiting
Birmingham, Alabama, United States, 35233
Contact: Sharon A. Spencer    205-934-0309      
Principal Investigator: Sharon A. Spencer         
The Kirklin Clinic at Acton Road Recruiting
Birmingham, Alabama, United States, 35243
Contact: Sharon A. Spencer    205-934-0309      
Principal Investigator: Sharon A. Spencer         
United States, Arizona
The University of Arizona Medical Center-University Campus Active, not recruiting
Tucson, Arizona, United States, 85724
United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Matthew E. Hardee    501-686-8274      
Principal Investigator: Matthew E. Hardee         
United States, California
Sutter Cancer Centers Radiation Oncology Services-Auburn Recruiting
Auburn, California, United States, 95603
Contact: Christopher U. Jones    415-209-2686    bernicl@sutterhealth.org   
Principal Investigator: Christopher U. Jones         
Providence Saint Joseph Medical Center/Disney Family Cancer Center Recruiting
Burbank, California, United States, 91505
Contact: Matthew C. Solhjem    503-215-6412    Julie.Cramer@providence.org   
Principal Investigator: Matthew C. Solhjem         
Sutter Cancer Centers Radiation Oncology Services-Cameron Park Recruiting
Cameron Park, California, United States, 95682
Contact: Christopher U. Jones    415-209-2686    bernicl@sutterhealth.org   
Principal Investigator: Christopher U. Jones         
Mercy San Juan Medical Center Active, not recruiting
Carmichael, California, United States, 95608
UC San Diego Moores Cancer Center Active, not recruiting
La Jolla, California, United States, 92093
Memorial Medical Center Recruiting
Modesto, California, United States, 95355
Contact: Christopher U. Jones    415-209-2686    bernicl@sutterhealth.org   
Principal Investigator: Christopher U. Jones         
UC Irvine Health/Chao Family Comprehensive Cancer Center Recruiting
Orange, California, United States, 92868
Contact: Chaitali S. Nangia    877-827-8839    ucstudy@uci.edu   
Principal Investigator: Chaitali S. Nangia         
Stanford Cancer Institute Recruiting
Palo Alto, California, United States, 94304
Contact: Quynh-Thu X. Le    650-498-7061    clinicaltrials@med.stanford.edu   
Principal Investigator: Quynh-Thu X. Le         
Sutter Cancer Centers Radiation Oncology Services-Roseville Recruiting
Roseville, California, United States, 95661
Contact: Christopher U. Jones    415-209-2686    bernicl@sutterhealth.org   
Principal Investigator: Christopher U. Jones         
Radiological Associates of Sacramento Withdrawn
Sacramento, California, United States, 95815
Sutter General Hospital Recruiting
Sacramento, California, United States, 95816
Contact: Christopher U. Jones    415-209-2686    bernicl@sutterhealth.org   
Principal Investigator: Christopher U. Jones         
University of California Davis Comprehensive Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Shyam S. Rao    916-734-3089      
Principal Investigator: Shyam S. Rao         
Saint Helena Hospital Recruiting
Saint Helena, California, United States, 94574
Contact: David J. Tate    707-967-3698      
Principal Investigator: David J. Tate         
UCSF Medical Center-Mount Zion Recruiting
San Francisco, California, United States, 94115
Contact: Sue S. Yom    877-827-3222      
Principal Investigator: Sue S. Yom         
Sutter Cancer Centers Radiation Oncology Services-Vacaville Recruiting
Vacaville, California, United States, 95687
Contact: Christopher U. Jones    415-209-2686    bernicl@sutterhealth.org   
Principal Investigator: Christopher U. Jones         
United States, Colorado
University of Colorado Cancer Center - Anschutz Cancer Pavilion Recruiting
Aurora, Colorado, United States, 80045
Contact: David Raben    720-848-0650      
Principal Investigator: David Raben         
Rocky Mountain Cancer Centers-Boulder Recruiting
Boulder, Colorado, United States, 80304
Contact: Keren Sturtz    888-785-6789      
Principal Investigator: Keren Sturtz         
Penrose-Saint Francis Healthcare Recruiting
Colorado Springs, Colorado, United States, 80907
Contact: Keren Sturtz    888-785-6789      
Principal Investigator: Keren Sturtz         
Porter Adventist Hospital Recruiting
Denver, Colorado, United States, 80210
Contact: Keren Sturtz    888-785-6789      
Principal Investigator: Keren Sturtz         
Rocky Mountain Cancer Centers-Littleton Recruiting
Littleton, Colorado, United States, 80120
Contact: Keren Sturtz    888-785-6789      
Principal Investigator: Keren Sturtz         
Longmont United Hospital Recruiting
Longmont, Colorado, United States, 80501
Contact: Keren Sturtz    888-785-6789      
Principal Investigator: Keren Sturtz         
McKee Medical Center Recruiting
Loveland, Colorado, United States, 80539
Contact: Keren Sturtz    888-785-6789      
Principal Investigator: Keren Sturtz         
Parker Adventist Hospital Recruiting
Parker, Colorado, United States, 80138
Contact: Keren Sturtz    888-785-6789      
Principal Investigator: Keren Sturtz         
United States, Connecticut
University of Connecticut Recruiting
Farmington, Connecticut, United States, 06030
Contact: Upendra P. Hegde    800-579-7822      
Principal Investigator: Upendra P. Hegde         
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Zain A. Husain    203-785-5702      
Principal Investigator: Zain A. Husain         
United States, Delaware
Christiana Care Health System-Christiana Hospital Recruiting
Newark, Delaware, United States, 19718
Contact: Adam Raben    302-733-6227      
Principal Investigator: Adam Raben         
United States, Florida
University of Miami Sylvester Comprehensive Cancer Center at Deerfield Beach Recruiting
Deerfield Beach, Florida, United States, 33442
Contact: Nagy Elsayyad    866-574-5124    Sylvester@emergingmed.com   
Principal Investigator: Nagy Elsayyad         
University of Miami Miller School of Medicine-Sylvester Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Nagy Elsayyad    866-574-5124    Sylvester@emergingmed.com   
Principal Investigator: Nagy Elsayyad         
Florida Hospital Orlando Withdrawn
Orlando, Florida, United States, 32803
UF Cancer Center at Orlando Health Recruiting
Orlando, Florida, United States, 32806
Contact: Rafael R. Manon    321-841-7246    CancerClinicalTrials@orlandohealth.com   
Principal Investigator: Rafael R. Manon         
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Andrea (Andy) M. Trotti    800-456-7121    canceranswers@moffitt.org   
Principal Investigator: Andrea (Andy) M. Trotti         
United States, Georgia
Emory University/Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: Jonathan J. Beitler    404-778-1868      
Principal Investigator: Jonathan J. Beitler         
Georgia Regents University Medical Center Recruiting
Augusta, Georgia, United States, 30912
Contact: Sharad A. Ghamande    706-721-1663    cancer@georgiahealth.edu   
Principal Investigator: Sharad A. Ghamande         
Memorial University Medical Center Recruiting
Savannah, Georgia, United States, 31404
Contact: Aaron W. Pederson    912-350-8568      
Principal Investigator: Aaron W. Pederson         
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Recruiting
Savannah, Georgia, United States, 31405
Contact: Joshua T. Mckenzie    800-622-6877      
Principal Investigator: Joshua T. Mckenzie         
United States, Hawaii
Queen's Medical Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Paul A. DeMare    808-545-8548      
Principal Investigator: Paul A. DeMare         
The Cancer Center of Hawaii-Liliha Recruiting
Honolulu, Hawaii, United States, 96817
Contact: Paul A. DeMare    808-545-8548      
Principal Investigator: Paul A. DeMare         
United States, Illinois
University of Illinois Withdrawn
Chicago, Illinois, United States, 60612
John H Stroger Jr Hospital of Cook County Recruiting
Chicago, Illinois, United States, 60612-3785
Contact: Thomas E. Lad    312-864-6000      
Principal Investigator: Thomas E. Lad         
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Bharat B. Mittal    312-695-1301    cancer@northwestern.edu   
Principal Investigator: Bharat B. Mittal         
Decatur Memorial Hospital Recruiting
Decatur, Illinois, United States, 62526
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Crossroads Cancer Center Active, not recruiting
Effingham, Illinois, United States, 62401
NorthShore University HealthSystem-Evanston Hospital Recruiting
Evanston, Illinois, United States, 60201
Contact: Bruce E. Brockstein    847-570-2109      
Principal Investigator: Bruce E. Brockstein         
NorthShore University HealthSystem-Glenbrook Hospital Recruiting
Glenview, Illinois, United States, 60026
Contact: Bruce E. Brockstein    847-570-2109      
Principal Investigator: Bruce E. Brockstein         
NorthShore University HealthSystem-Highland Park Hospital Recruiting
Highland Park, Illinois, United States, 60035
Contact: Bruce E. Brockstein    847-570-2109      
Principal Investigator: Bruce E. Brockstein         
Advocate Christ Medical Center Recruiting
Oak Lawn, Illinois, United States, 60453-2699
Contact: Amar Hamad    800-323-8622      
Principal Investigator: Amar Hamad         
OSF Saint Francis Medical Center Radiation Oncology Service at the Central Illinois Comprehensive CC Recruiting
Peoria, Illinois, United States, 61615-7827
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
OSF Saint Francis Medical Center Recruiting
Peoria, Illinois, United States, 61637
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
SwedishAmerican Regional Cancer Center/ACT Recruiting
Rockford, Illinois, United States, 61114
Contact: Harvey E. Einhorn    779-696-9400    cancercare@swedishamerican.org   
Principal Investigator: Harvey E. Einhorn         
Carle Cancer Center Recruiting
Urbana, Illinois, United States, 61801
Contact: Sinisa Stanic    800-446-5532      
Principal Investigator: Sinisa Stanic         
United States, Indiana
Elkhart General Hospital Terminated
Elkhart, Indiana, United States, 46515
Radiation Oncology Associates PC Recruiting
Fort Wayne, Indiana, United States, 46804
Contact: Brian K. Chang    260-373-8888    parkviewresearch@parkview.com   
Principal Investigator: Brian K. Chang         
Parkview Hospital Randallia Recruiting
Fort Wayne, Indiana, United States, 46805
Contact: Brian K. Chang    260-373-8888    parkviewresearch@parkview.com   
Principal Investigator: Brian K. Chang         
IU Health Goshen Center for Cancer Care Active, not recruiting
Goshen, Indiana, United States, 46526
Indiana University/Melvin and Bren Simon Cancer Center Active, not recruiting
Indianapolis, Indiana, United States, 46202
IU Health Methodist Hospital Active, not recruiting
Indianapolis, Indiana, United States, 46202
IU Health Central Indiana Cancer Centers-East Recruiting
Indianapolis, Indiana, United States, 46219
Contact: Gordon A. Watson    317-356-2422      
Principal Investigator: Gordon A. Watson         
Michiana Hematology Oncology PC-Mishawaka Terminated
Mishawaka, Indiana, United States, 46545
Memorial Hospital of South Bend Recruiting
South Bend, Indiana, United States, 46601
Contact: David A. Hornback    800-284-7370      
Principal Investigator: David A. Hornback         
Northern Indiana Cancer Research Consortium CCOP Recruiting
South Bend, Indiana, United States, 46628
Contact: Binh N. Tran    574-237-1328      
Principal Investigator: Binh N. Tran         
United States, Iowa
McFarland Clinic PC-William R Bliss Cancer Center Recruiting
Ames, Iowa, United States, 50010
Contact: Joseph J. Merchant    515-239-2621      
Principal Investigator: Joseph J. Merchant         
Iowa Methodist Medical Center Active, not recruiting
Des Moines, Iowa, United States, 50309
United States, Kansas
University of Kansas Cancer Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Parvesh Kumar    913-945-7552    ctnursenav@kumc.edu   
Principal Investigator: Parvesh Kumar         
Olathe Medical Center Recruiting
Olathe, Kansas, United States, 66061
Contact: Parvesh Kumar    913-945-7552    ctnursenav@kumc.edu   
Principal Investigator: Parvesh Kumar         
Kansas City Cancer Centers-Southwest Recruiting
Overland Park, Kansas, United States, 66210
Contact: Parvesh Kumar    913-945-7552    ctnursenav@kumc.edu   
Principal Investigator: Parvesh Kumar         
Salina Regional Health Center Recruiting
Salina, Kansas, United States, 67401
Contact: Parvesh Kumar    913-945-7552    ctnursenav@kumc.edu   
Principal Investigator: Parvesh Kumar         
United States, Kentucky
University of Kentucky/Markey Cancer Center Recruiting
Lexington, Kentucky, United States, 40536
Contact: Mahesh R. Kudrimoti    859-257-3379      
Principal Investigator: Mahesh R. Kudrimoti         
The James Graham Brown Cancer Center at University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Neal E. Dunlap    866-530-5516      
Principal Investigator: Neal E. Dunlap         
United States, Louisiana
Tulane University Health Sciences Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: William R. Robinson    504-988-6121      
Principal Investigator: William R. Robinson         
Ochsner Medical Center Jefferson Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Troy G. Scroggins    888-562-4763      
Principal Investigator: Troy G. Scroggins         
United States, Maryland
Greater Baltimore Medical Center Recruiting
Baltimore, Maryland, United States, 21204
Contact: Marshall A. Levine    443-849-3706      
Principal Investigator: Marshall A. Levine         
Johns Hopkins University/Sidney Kimmel Cancer Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Ana P. Kiess    410-955-8804    jhcccro@jhmi.edu   
Principal Investigator: Ana P. Kiess         
Holy Cross Hospital Active, not recruiting
Silver Spring, Maryland, United States, 20910
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Minh T. Truong    617-638-8265      
Principal Investigator: Minh T. Truong         
United States, Michigan
Saint Joseph Mercy Hospital Recruiting
Ann Arbor, Michigan, United States, 48106-0995
Contact: Samir Narayan    734-712-4673      
Principal Investigator: Samir Narayan         
University of Michigan Comprehensive Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Avraham Eisbruch    800-865-1125      
Principal Investigator: Avraham Eisbruch         
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Eleanor M. Walker    313-916-1784      
Principal Investigator: Eleanor M. Walker         
West Michigan Cancer Center Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Sunil Nagpal    269-373-7458      
Principal Investigator: Sunil Nagpal         
Saint Mary Mercy Hospital Recruiting
Livonia, Michigan, United States, 48154
Contact: Samir Narayan    734-712-4673      
Principal Investigator: Samir Narayan         
William Beaumont Hospital-Royal Oak Withdrawn
Royal Oak, Michigan, United States, 48073
William Beaumont Hospital - Troy Withdrawn
Troy, Michigan, United States, 48098
Henry Ford Medical Center - West Bloomfield Recruiting
West Bloomfield, Michigan, United States, 48322
Contact: Eleanor M. Walker    313-916-1784      
Principal Investigator: Eleanor M. Walker         
United States, Minnesota
Miller-Dwan Hospital Recruiting
Duluth, Minnesota, United States, 55805
Contact: Bret E. Friday    888-203-7267      
Principal Investigator: Bret E. Friday         
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Paul W. Sperduto    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Paul W. Sperduto         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Robert L. Foote    507-538-7623      
Principal Investigator: Robert L. Foote         
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Shankar P. Giri    601-815-6700      
Principal Investigator: Shankar P. Giri         
United States, Missouri
Saint Francis Medical Center Recruiting
Cape Girardeau, Missouri, United States, 63703
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Cape Radiation Oncology Terminated
Cape Girardeau, Missouri, United States, 63703
University of Missouri - Ellis Fischel Recruiting
Columbia, Missouri, United States, 65212
Contact: Donald C. Doll    573-882-7440      
Principal Investigator: Donald C. Doll         
Kansas City Cancer Centers - North Recruiting
Kansas City, Missouri, United States, 64154
Contact: Parvesh Kumar    913-945-7552    ctnursenav@kumc.edu   
Principal Investigator: Parvesh Kumar         
Kansas City Cancer Center - South Recruiting
Kansas City, Missouri, United States, 64131
Contact: Parvesh Kumar    913-945-7552    ctnursenav@kumc.edu   
Principal Investigator: Parvesh Kumar         
North Kansas City Hospital Recruiting
Kansas City, Missouri, United States, 64116
Contact: Parvesh Kumar    913-945-7552    ctnursenav@kumc.edu   
Principal Investigator: Parvesh Kumar         
Kansas City Cancer Center-Lee's Summit Recruiting
Lee's Summit, Missouri, United States, 64064
Contact: Parvesh Kumar    913-945-7552    ctnursenav@kumc.edu   
Principal Investigator: Parvesh Kumar         
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Wade L. Thorstad    800-600-3606    info@siteman.wustl.edu   
Principal Investigator: Wade L. Thorstad         
Mercy Hospital Saint Louis Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Jay W. Carlson    800-821-7532      
Principal Investigator: Jay W. Carlson         
Missouri Baptist Medical Center Recruiting
Saint Louis, Missouri, United States, 63131
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Barnes-Jewish West County Hospital Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Wade L. Thorstad    800-600-3606    info@siteman.wustl.edu   
Principal Investigator: Wade L. Thorstad         
Siteman Cancer Center-South County Terminated
Saint Louis, Missouri, United States, 63129
Siteman Cancer Center - Saint Peters Recruiting
Saint Peters, Missouri, United States, 63376
Contact: Wade L. Thorstad    800-600-3606    info@siteman.wustl.edu   
Principal Investigator: Wade L. Thorstad         
Mercy Hospital Springfield Recruiting
Springfield, Missouri, United States, 65804
Contact: Jay W. Carlson    800-821-7532      
Principal Investigator: Jay W. Carlson         
CoxHealth South Hospital Recruiting
Springfield, Missouri, United States, 65807
Contact: Jay W. Carlson    800-821-7532      
Principal Investigator: Jay W. Carlson         
United States, Nebraska
Nebraska Methodist Hospital Recruiting
Omaha, Nebraska, United States, 68114
Contact: Tien-Shew W. Huang    402-354-5144      
Principal Investigator: Tien-Shew W. Huang         
Alegent Health Bergan Mercy Medical Center Recruiting
Omaha, Nebraska, United States, 68124
Contact: Mehmet S. Copur    800-998-2119      
Principal Investigator: Mehmet S. Copur         
United States, New Jersey
Memorial Sloan Kettering Cancer Center at Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Nancy Y. Lee    212-639-7202      
Principal Investigator: Nancy Y. Lee         
Virtua Memorial Recruiting
Mount Holly, New Jersey, United States, 08060
Contact: Lemuel S. Ariaratnam    609-914-6762      
Principal Investigator: Lemuel S. Ariaratnam         
Sparta Cancer Treatment Center Recruiting
Sparta, New Jersey, United States, 07871
Contact: Jennifer M. Johnson    215-955-6084      
Principal Investigator: Jennifer M. Johnson         
Virtua West Jersey Hospital Voorhees Recruiting
Voorhees, New Jersey, United States, 08043
Contact: Lemuel S. Ariaratnam    609-914-6762      
Principal Investigator: Lemuel S. Ariaratnam         
United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87102
Contact: Thomas M. Schroeder    505-272-6972      
Principal Investigator: Thomas M. Schroeder         
New Mexico Oncology Hematology Consultants Recruiting
Albuquerque, New Mexico, United States, 87109
Contact: Thomas M. Schroeder    505-272-6972      
Principal Investigator: Thomas M. Schroeder         
United States, New York
Southside Hospital Withdrawn
Bay Shore, New York, United States, 11706
The New York Methodist Hospital Recruiting
Brooklyn, New York, United States, 11215
Contact: Krishnamurthi Sundaram    718-270-8216    sima.terebelo@downstate.edu   
Principal Investigator: Krishnamurthi Sundaram         
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Anurag K. Singh    877-275-7724      
Principal Investigator: Anurag K. Singh         
Sands Cancer Center Recruiting
Canandiaqua, New York, United States, 14424
Contact: Yuhchyau Chen    585-275-5830      
Principal Investigator: Yuhchyau Chen         
Memorial Sloan Kettering Cancer Center Commack Recruiting
Commack, New York, United States, 11725
Contact: Nancy Y. Lee    212-639-7202      
Principal Investigator: Nancy Y. Lee         
Arnot Ogden Medical Center/Falck Cancer Center Recruiting
Elmira, New York, United States, 14905
Contact: Chi K. Tsang    607-271-7000      
Principal Investigator: Chi K. Tsang         
North Shore-LIJ Health System/Center for Advanced Medicine Withdrawn
New Hyde Park, New York, United States, 11040
Beth Israel Medical Center Recruiting
New York, New York, United States, 10003
Contact: Bruce E. Culliney    212-844-6286      
Principal Investigator: Bruce E. Culliney         
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Sewanti A. Limaye    212-305-8615      
Principal Investigator: Sewanti A. Limaye         
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Nancy Y. Lee    212-639-7202      
Principal Investigator: Nancy Y. Lee         
Highland Hospital Recruiting
Rochester, New York, United States, 14620
Contact: Yuhchyau Chen    585-275-5830      
Principal Investigator: Yuhchyau Chen         
University Radiation Oncology Recruiting
Rochester, New York, United States, 14626
Contact: Yuhchyau Chen    585-275-5830      
Principal Investigator: Yuhchyau Chen         
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Yuhchyau Chen    585-275-5830      
Principal Investigator: Yuhchyau Chen         
Memorial Sloan-Kettering Cancer Center Rockville Centre Recruiting
Rockville Centre, New York, United States, 11570
Contact: Nancy Y. Lee    212-639-7202      
Principal Investigator: Nancy Y. Lee         
Memorial Sloan-Kettering Cancer Center Sleepy Hollow Recruiting
Sleepy Hollow, New York, United States, 10591
Contact: Nancy Y. Lee    212-639-7202      
Principal Investigator: Nancy Y. Lee         
State University of New York Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Contact: Michael A. Lacombe    315-464-5476      
Principal Investigator: Michael A. Lacombe         
Memorial Sloan-Kettering Cancer Center West Harrison Recruiting
West Harrison, New York, United States, 10604
Contact: Nancy Y. Lee    212-639-7202      
Principal Investigator: Nancy Y. Lee         
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Bhishamjit S. Chera    877-668-0683    cancerclinicaltrials@med.unc.edu   
Principal Investigator: Bhishamjit S. Chera         
East Carolina University Active, not recruiting
Greenville, North Carolina, United States, 27858
Kinston Medical Specialists PA Recruiting
Kinston, North Carolina, United States, 28501
Contact: Peter R. Watson    252-559-2200      
Principal Investigator: Peter R. Watson         
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Kathryn M. Greven    336-713-6771      
Principal Investigator: Kathryn M. Greven         
United States, Ohio
Akron General Medical Center Recruiting
Akron, Ohio, United States, 44307
Contact: Mitchel L. Fromm    330-344-6348      
Principal Investigator: Mitchel L. Fromm         
Summa Akron City Hospital/Cooper Cancer Center Withdrawn
Akron, Ohio, United States, 44304
Summa Barberton Hospital Withdrawn
Barberton, Ohio, United States, 44203
UHHS-Chagrin Highlands Medical Center Recruiting
Beachwood, Ohio, United States, 44122
Contact: Min Yao    800-641-2422      
Principal Investigator: Min Yao         
Geaugra Hospital Recruiting
Chardon, Ohio, United States, 44024
Contact: Min Yao    800-641-2422      
Principal Investigator: Min Yao         
Adena Regional Medical Center Recruiting
Chillicothe, Ohio, United States, 45601
Contact: John P. Kuebler    614-488-2745    sheree@columbusccop.org   
Principal Investigator: John P. Kuebler         
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Kevin P. Redmond    513-558-4553    uchealthnews@uc.edu   
Principal Investigator: Kevin P. Redmond         
Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44106
Contact: Min Yao    800-641-2422      
Principal Investigator: Min Yao         
Cleveland Clinic Cancer Center/Fairview Hospital Recruiting
Cleveland, Ohio, United States, 44111
Contact: David J. Adelstein    866-223-8100      
Principal Investigator: David J. Adelstein         
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: David J. Adelstein    866-223-8100      
Principal Investigator: David J. Adelstein         
Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Virginia M. Diavolitsis    800-293-5066    Jamesline@osumc.edu   
Principal Investigator: Virginia M. Diavolitsis         
Mercy Cancer Center-Elyria Recruiting
Elyria, Ohio, United States, 44035
Contact: Min Yao    800-641-2422      
Principal Investigator: Min Yao         
Cleveland Clinic Cancer Center Independence Recruiting
Independence, Ohio, United States, 44131
Contact: David J. Adelstein    866-223-8100      
Principal Investigator: David J. Adelstein         
Hillcrest Hospital Cancer Center Recruiting
Mayfield Heights, Ohio, United States, 44124
Contact: David J. Adelstein    866-223-8100      
Principal Investigator: David J. Adelstein         
Summa Health Center at Lake Medina Withdrawn
Medina, Ohio, United States, 44256
Lake University Ireland Cancer Center Recruiting
Mentor, Ohio, United States, 44060
Contact: Min Yao    800-641-2422      
Principal Investigator: Min Yao         
Southwest General Health Center Ireland Cancer Center Recruiting
Middleburg Heights, Ohio, United States, 44130
Contact: Min Yao    800-641-2422      
Principal Investigator: Min Yao         
University Hospitals Parma Medical Center Recruiting
Parma, Ohio, United States, 44129
Contact: Min Yao    800-641-2422      
Principal Investigator: Min Yao         
Ireland Cancer Center at Firelands Regional Medical Center Recruiting
Sandusky, Ohio, United States, 44870
Contact: Min Yao    800-641-2422      
Principal Investigator: Min Yao         
North Coast Cancer Care Recruiting
Sandusky, Ohio, United States, 44870
Contact: David J. Adelstein    866-223-8100      
Principal Investigator: David J. Adelstein         
Cleveland Clinic Cancer Center Strongsville Recruiting
Strongsville, Ohio, United States, 44136
Contact: David J. Adelstein    866-223-8100      
Principal Investigator: David J. Adelstein         
University Pointe Recruiting
West Chester, Ohio, United States, 45069
Contact: Kevin P. Redmond    513-558-4553    uchealthnews@uc.edu   
Principal Investigator: Kevin P. Redmond         
UHHS-Westlake Medical Center Recruiting
Westlake, Ohio, United States, 44145
Contact: Min Yao    800-641-2422      
Principal Investigator: Min Yao         
Cleveland Clinic Wooster Specialty Center Recruiting
Wooster, Ohio, United States, 44691
Contact: David J. Adelstein    866-223-8100      
Principal Investigator: David J. Adelstein         
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Terence S. Herman    405-271-4272    julie-traylor@ouhsc.edu   
Principal Investigator: Terence S. Herman         
United States, Oregon
Clackamas Radiation Oncology Center Recruiting
Clackamas, Oregon, United States, 97015
Contact: Matthew C. Solhjem    503-215-6412    Julie.Cramer@providence.org   
Principal Investigator: Matthew C. Solhjem         
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
Contact: Matthew C. Solhjem    503-215-6412    Julie.Cramer@providence.org   
Principal Investigator: Matthew C. Solhjem         
Providence Saint Vincent Medical Center Recruiting
Portland, Oregon, United States, 97225
Contact: Matthew C. Solhjem    503-215-6412    Julie.Cramer@providence.org   
Principal Investigator: Matthew C. Solhjem         
United States, Pennsylvania
UPMC-Heritage Valley Health System Beaver Recruiting
Beaver, Pennsylvania, United States, 15009
Contact: Julie E. Bauman    412-647-8073      
Principal Investigator: Julie E. Bauman         
UPMC Cancer Center at Jefferson Regional Medical Center Recruiting
Clairton, Pennsylvania, United States, 15025
Contact: Julie E. Bauman    412-647-8073      
Principal Investigator: Julie E. Bauman         
UPMC Cancer Centers - Arnold Palmer Pavilion Recruiting
Greensburg, Pennsylvania, United States, 15601
Contact: Julie E. Bauman    412-647-8073      
Principal Investigator: Julie E. Bauman         
PinnacleHealth Cancer Center-Community Campus Recruiting
Harrisburg, Pennsylvania, United States, 17109
Contact: Brij M. Sood    717-724-6765    klitchfield@PINNACLEHEALTH.org   
Principal Investigator: Brij M. Sood         
Penn State Milton S Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033-0850
Contact: Salah M. Almokadem    717-531-3779    CTO@hmc.psu.edu   
Principal Investigator: Salah M. Almokadem         
UPMC Cancer Center at UPMC McKeesport Recruiting
McKeesport, Pennsylvania, United States, 15132
Contact: Julie E. Bauman    412-647-8073      
Principal Investigator: Julie E. Bauman         
UPMC-Coraopolis/Heritage Valley Radiation Oncology Recruiting
Moon Township, Pennsylvania, United States, 15108
Contact: Julie E. Bauman    412-647-8073      
Principal Investigator: Julie E. Bauman         
UPMC Cancer Center-Natrona Heights Terminated
Natrona Heights, Pennsylvania, United States, 15065
Jameson Health System North Campus Terminated
New Castle, Pennsylvania, United States, 16105
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Jennifer M. Johnson    215-955-6084      
Principal Investigator: Jennifer M. Johnson         
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Thomas J. Galloway    215-728-4790      
Principal Investigator: Thomas J. Galloway         
Temple University Hospital Active, not recruiting
Philadelphia, Pennsylvania, United States, 19140
UPMC-Saint Clair Hospital Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15243
Contact: Julie E. Bauman    412-647-8073      
Principal Investigator: Julie E. Bauman         
UPMC-Shadyside Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Julie E. Bauman    412-647-8073      
Principal Investigator: Julie E. Bauman         
UPMC-Passavant Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15237
Contact: Julie E. Bauman    412-647-8073      
Principal Investigator: Julie E. Bauman         
UPMC-Saint Margaret Recruiting
Pittsburgh, Pennsylvania, United States, 15215
Contact: Julie E. Bauman    412-647-8073      
Principal Investigator: Julie E. Bauman         
UPMC Washington Hospital Radiation Oncology Recruiting
Washington, Pennsylvania, United States, 15301
Contact: Julie E. Bauman    412-647-8073      
Principal Investigator: Julie E. Bauman         
Reading Hospital Recruiting
West Reading, Pennsylvania, United States, 19611
Contact: Albert Yuen    610-988-9323      
Principal Investigator: Albert Yuen         
United States, South Carolina
AnMed Health Cancer Center Active, not recruiting
Anderson, South Carolina, United States, 29621
Greenville Health System Cancer Institute-Faris Recruiting
Greenville, South Carolina, United States, 29605
Contact: David L. Grisell    864-241-6251      
Principal Investigator: David L. Grisell         
Greenville Health System Cancer Institute-Eastside Recruiting
Greenville, South Carolina, United States, 29615
Contact: David L. Grisell    864-241-6251      
Principal Investigator: David L. Grisell         
Gibbs Cancer Center-Pelham Recruiting
Greer, South Carolina, United States, 29651
Contact: Patricia C. Griffin    800-486-5941      
Principal Investigator: Patricia C. Griffin         
Greenville Health System Cancer Institute-Greer Recruiting
Greer, South Carolina, United States, 29650
Contact: David L. Grisell    864-241-6251      
Principal Investigator: David L. Grisell         
Greenville Health System Cancer Institute-Seneca Recruiting
Seneca, South Carolina, United States, 29672
Contact: David L. Grisell    864-241-6251      
Principal Investigator: David L. Grisell         
Spartanburg Medical Center Recruiting
Spartanburg, South Carolina, United States, 29303
Contact: Patricia C. Griffin    800-486-5941      
Principal Investigator: Patricia C. Griffin         
Greenville Health System Cancer Institute-Spartanburg Recruiting
Spartanburg, South Carolina, United States, 29307
Contact: David L. Grisell    864-241-6251      
Principal Investigator: David L. Grisell         
United States, South Dakota
Rapid City Regional Hospital Recruiting
Rapid City, South Dakota, United States, 57701
Contact: Michael J. Swartz    605-716-3982    research@rcrh.org   
Principal Investigator: Michael J. Swartz         
United States, Tennessee
Vanderbilt University/Ingram Cancer Center Withdrawn
Nashville, Tennessee, United States, 37232
United States, Texas
UT Southwestern/Simmons Cancer Center-Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: David L. Schwartz    214-648-7097      
Principal Investigator: David L. Schwartz         
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555-0565
Contact: Lee R. Wiederhold    409-772-1950    clinical.research@utmb.edu   
Principal Investigator: Lee R. Wiederhold         
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Michael E. Kupferman    713-792-3245      
Principal Investigator: Michael E. Kupferman         
UTMB Cancer Center at Victory Lakes Recruiting
League City, Texas, United States, 77573
Contact: Lee R. Wiederhold    409-772-1950    clinical.research@utmb.edu   
Principal Investigator: Lee R. Wiederhold         
Covenant Medical Center-Lakeside Recruiting
Lubbock, Texas, United States, 79410
Contact: Paul J. Anderson    806-725-8000    jaccresearch@covhs.org   
Principal Investigator: Paul J. Anderson         
United States, Utah
Intermountain Medical Center Recruiting
Murray, Utah, United States, 84157
Contact: R. J. Lee    801-507-3950      
Principal Investigator: R. J. Lee         
Dixie Medical Center Regional Cancer Center Recruiting
Saint George, Utah, United States, 84770
Contact: R. J. Lee    801-507-3950      
Principal Investigator: R. J. Lee         
Utah Cancer Specialists-Salt Lake City Recruiting
Salt Lake City, Utah, United States, 84106
Contact: R. J. Lee    801-507-3950      
Principal Investigator: R. J. Lee         
Huntsman Cancer Institute/University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Ying J. Hitchcock    801-581-4477    clinical.trials@hci.utah.edu   
Principal Investigator: Ying J. Hitchcock         
United States, Virginia
Inova Fairfax Hospital Recruiting
Falls Church, Virginia, United States, 22042
Contact: John F. Deeken    703-970-6431    john.deeken@inova.org   
Principal Investigator: John F. Deeken         
Sentara Cancer Institute at Sentara CarePlex Hospital Recruiting
Hampton, Virginia, United States, 23666
Contact: Scott S. Williams    757-388-2406      
Principal Investigator: Scott S. Williams         
Sentara Hospitals Recruiting
Norfolk, Virginia, United States, 23507
Contact: Scott S. Williams    757-388-2406      
Principal Investigator: Scott S. Williams         
Virginia Commonwealth University/Massey Cancer Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Shiyu Song    804-628-1939      
Principal Investigator: Shiyu Song         
Sentara Virginia Beach General Hospital Recruiting
Virginia Beach, Virginia, United States, 23454
Contact: Scott S. Williams    757-388-2406      
Principal Investigator: Scott S. Williams         
United States, Washington
Saint Francis Hospital Recruiting
Federal Way, Washington, United States, 98003
Contact: Mehmet S. Copur    800-998-2119      
Principal Investigator: Mehmet S. Copur         
Tri-Cities Cancer Center Recruiting
Kennewick, Washington, United States, 99336
Contact: Cristina P. Rodriguez    800-804-8824      
Principal Investigator: Cristina P. Rodriguez         
Saint John Medical Center Recruiting
Longview, Washington, United States, 98632
Contact: Matthew C. Solhjem    503-215-6412    Julie.Cramer@providence.org   
Principal Investigator: Matthew C. Solhjem         
Skagit Valley Hospital Regional Cancer Care Center Recruiting
Mount Vernon, Washington, United States, 98273
Contact: Cristina P. Rodriguez    800-804-8824      
Principal Investigator: Cristina P. Rodriguez         
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: Cristina P. Rodriguez    800-804-8824      
Principal Investigator: Cristina P. Rodriguez         
Spokane Valley Cancer Center-Mayfair Recruiting
Spokane, Washington, United States, 99208
Contact: Cristina P. Rodriguez    800-804-8824      
Principal Investigator: Cristina P. Rodriguez         
Wenatchee Valley Hospital and Clinics Recruiting
Wenatchee, Washington, United States, 98801
Contact: Cristina P. Rodriguez    800-804-8824      
Principal Investigator: Cristina P. Rodriguez         
United States, West Virginia
West Virginia University Healthcare Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Mohammed Almubarak    304-293-2745    sfilburn@hsc.wvu.edu   
Principal Investigator: Mohammed Almubarak         
Wheeling Hospital/Schiffler Cancer Center Recruiting
Wheeling, West Virginia, United States, 26003
Contact: Jondavid Pollock    304-243-6442      
Principal Investigator: Jondavid Pollock         
United States, Wisconsin
Saint Vincent Hospital Recruiting
Green Bay, Wisconsin, United States, 54301
Contact: James L. Leenstra    507-645-2655      
Principal Investigator: James L. Leenstra         
Saint Mary's Hospital Recruiting
Green Bay, Wisconsin, United States, 54303
Contact: James L. Leenstra    507-645-2655      
Principal Investigator: James L. Leenstra         
Gundersen Lutheran Medical Center Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Collin D. Driscoll    608-775-2385    cancerctr@gundluth.org   
Principal Investigator: Collin D. Driscoll         
Mayo Clinic Health System-Franciscan Healthcare Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: David J. Schwartz    608-392-9462      
Principal Investigator: David J. Schwartz         
University of Wisconsin Hospital and Clinics Recruiting
Madison, Wisconsin, United States, 53792
Contact: Paul M. Harari    877-405-6866      
Principal Investigator: Paul M. Harari         
Bay Area Medical Center Recruiting
Marinette, Wisconsin, United States, 54143
Contact: James L. Leenstra    507-645-2655      
Principal Investigator: James L. Leenstra         
Saint Joseph's Hospital Withdrawn
Marshfield, Wisconsin, United States, 54449
Froedtert and the Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Christopher J. Schultz    414-805-4380      
Principal Investigator: Christopher J. Schultz         
Marshfield Clinic-Minocqua Center Withdrawn
Minocqua, Wisconsin, United States, 54548
Saint Michael's Hospital Withdrawn
Stevens Point, Wisconsin, United States, 54481
Door County Cancer Center Recruiting
Sturgeon Bay, Wisconsin, United States, 54235-1495
Contact: James L. Leenstra    507-645-2655      
Principal Investigator: James L. Leenstra         
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Brock J. Debenham    780-432-8500      
Principal Investigator: Brock J. Debenham         
Canada, Saskatchewan
Allan Blair Cancer Centre Recruiting
Regina, Saskatchewan, Canada, S4T 7T1
Contact: Evgeny Sadikov    306-766-2213      
Principal Investigator: Evgeny Sadikov         
Saskatoon Cancer Centre Recruiting
Saskatoon, Saskatchewan, Canada, S7N 4H4
Contact: Ali A. El-Gayed    306-655-2914      
Principal Investigator: Ali A. El-Gayed         
China, Hong Kong
Chinese University of Hong Kong-Prince of Wales Hospital Recruiting
Shatin, Hong Kong, China, OX1 3UJ
Contact: Michael K. Kam    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Michael K. Kam         
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
NRG Oncology
Investigators
Principal Investigator: Paul Harari Radiation Therapy Oncology Group
  More Information

No publications provided

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: November 14, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Carcinoma, Verrucous
Laryngeal Diseases
Laryngeal Neoplasms
Oropharyngeal Neoplasms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Pharyngeal Neoplasms
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Stomatognathic Diseases
Antibodies
Antibodies, Monoclonal
Cetuximab
Cisplatin
Docetaxel
Antimitotic Agents
Antineoplastic Agents
Immunologic Factors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 07, 2016