Trial record 1 of 10 for:    RTOG 1016
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Radiation Therapy With Cisplatin or Cetuximab in Treating Patients With Oropharyngeal Cancer

This study is currently recruiting participants.
Verified January 2014 by Radiation Therapy Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT01302834
First received: February 22, 2011
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, 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 carry tumor-killing substances to them. It is not yet known whether radiation therapy is more effective with cisplatin or cetuximab in treating oropharyngeal cancer.

PURPOSE: This phase III trial is studying radiation therapy with cisplatin or cetuximab to see how well it works in treating patients with oropharyngeal cancer.


Condition Intervention Phase
Head and Neck Cancer
Precancerous Condition
Biological: cetuximab
Drug: cisplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Trial of Radiotherapy Plus Cetuximab Versus Chemoradiotherapy in HPV-Associated Oropharynx Cancer

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Overall survival [ Time Frame: From randomization to date of failure (death) or last follow-up. Analysis occurs after 219 failures have been reported. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: From randomization to date of failure (local, regional or distant progression or death) or last follow-up. Analysis occurs at the same time as the primary outcome. ] [ Designated as safety issue: No ]
  • Local-regional failure [ Time Frame: From randomization to date of failure (local or regional progression) or distant progression or death or last follow-up. Analysis occurs at the same time as the primary outcome. ] [ Designated as safety issue: No ]
  • Distant metastasis [ 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 ]
  • Acute toxicities (CTCAE v. 4) and overall toxicity burden at end of treatment and at 1, 3, and 6 months after completion of treatment [ Time Frame: From start of treatment to 6 months after end of treatment. ] [ Designated as safety issue: Yes ]
  • Late toxicities (CTCAE v. 4) at 1, 2, and 5 years [ Time Frame: From 6 months after end of treatment to 5 years after end of treatment. ] [ Designated as safety issue: Yes ]
  • Second primary cancers [ Time Frame: From randomization to date of failure (second primary cancer) or death or last follow-up. Analysis occurs at the same time as the primary outcome. ] [ Designated as safety issue: No ]
  • Pattern of failure [ 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 ]
  • Early deaths [ Time Frame: From randomization to 30 days after end of treatment. ] [ Designated as safety issue: Yes ]
  • Feeding tube rate at 1 year [ Time Frame: From randomization to 1 year. ] [ Designated as safety issue: No ]
  • EORTC QLC-C30 at baseline, end of treatment, 3, 6, and 12 months from end of treatment. [ Time Frame: From randomziation to 1 year after end of treatment. ] [ Designated as safety issue: No ]
  • EORTC QLQ-H&N35 at baseline, end of treatment, 3, 6, and 12 months from end of treatment. [ Time Frame: From randomization to 1 year after end of treatment. ] [ Designated as safety issue: No ]
  • PRO-CTCAE-H&N at baseline, end of treatment, 3, 6, and 12 months from end of treatment. [ Time Frame: From randomization to 1 year after end of treatement. ] [ Designated as safety issue: No ]
  • EQ-5D at baseline, end of treatment, 3, 6, and 12 months from end of treatment. [ Time Frame: From randomization to 1 year after end of treatment. ] [ Designated as safety issue: No ]
  • Work Status Questionnaire at baseline, end of treatment, 3, 6, and 12 months. [ Time Frame: From randomization to 1 year after end of treatment. ] [ Designated as safety issue: No ]
  • Dental status at baseline, 12, 24, 60 and 120 months from end of treatment. [ Time Frame: From randomization to 10 years after end of treatment. ] [ Designated as safety issue: No ]
  • Hearing quality of life outcomes as measured by the HHIA-S at baseline, end of treatment and at 3, 6, and 12 months from end of treatment. [ Time Frame: From randomization to 1 year after end of treatment. ] [ Designated as safety issue: No ]
  • Behavioral Risk Assessment Survey (BRASS) at baseline. [ Time Frame: Prior to randomization. ] [ Designated as safety issue: No ]
  • Translational research analysis [ Time Frame: From randomization to date of death or last follow-up. ] [ Designated as safety issue: No ]

Estimated Enrollment: 706
Study Start Date: June 2011
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients undergo image-guided intensity-modulated radiation therapy (IMRT) once daily on days 1-4 and twice daily on day 5 weekly for 6 weeks. Patients also receive high-dose cisplatin IV over 1-2 hours on days 1 and 22.
Drug: cisplatin
Given IV
Active Comparator: Arm II
Beginning 1 week prior to IMRT, patients receive cetuximab IV over 2 hours. Patients then receive cetuximab IV over 1 hour once weekly for 7 weeks. Patients undergo IMRT as in arm I.
Biological: cetuximab
Given IV

Detailed Description:

OBJECTIVES:

Primary

  • To determine whether substitution of cisplatin with cetuximab will result in comparable 5-year overall survival.

Secondary

  • To monitor and compare progression-free survival for "safety".
  • To compare patterns of failure (locoregional vs distant).
  • To compare acute toxicity profiles (and overall toxicity burden).
  • To compare overall quality of life (QOL) short-term (< 6 months) and long-term (2 years).
  • To compare QOL Swallowing Domains short-term and long-term.
  • To compare clinician-reported versus patient-reported CTCAE toxicity events.
  • To explore differences in the cost effectiveness of cetuximab as compared to cisplatin.
  • To explore differences in work status and time to return to work.
  • To compare patient-reported changes in hearing.
  • To compare CTCAE v. 4 late toxicity at 1, 2, and 5 years.
  • To evaluate the effect of tobacco exposure (and other exposures) as measured by standardized computer-assisted self interview (CASI) on overall survival and progression-free survival.
  • To pilot CASI collection of patient reported outcomes in a cooperative group setting.
  • To determine whether specific molecular profiles are associated with overall or progression-free survival.
  • To investigate associations between changes in serum biomarkers or HPV-specific cellular immune responses measured at baseline and three months with overall or progression-free survival.

OUTLINE: This is a multicenter study. Patients are stratified according to T stage (T1-2 vs T 3-4), N stage (N0-2a vs N2b-3), Zubrod performance status (0 vs 1), and smoking history (≤ 10 pack-years vs > 10 pack-years). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo image-guided intensity-modulated radiation therapy (IMRT) once daily on days 1-4 and twice daily on day 5 weekly for 6 weeks. Patients also receive high-dose cisplatin IV over 1-2 hours on days 1 and 22.
  • Arm II: Beginning 1 week prior to IMRT, patients receive cetuximab IV over 2 hours. Patients then receive cetuximab IV over 1 hour once weekly for 7 weeks. Patients undergo IMRT as in arm I.

Tumor tissue and blood samples are collected at baseline and may also be collected at 3- and 6-month follow-up visits for correlative studies.

Patients may complete quality-of-life questionnaires and risk factors for head and neck cancer surveys at baseline, periodically during study, and at follow-up for 1 year.

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls)

    • No cancer from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal, or lip), nasopharynx, hypopharynx, or larynx, even if p16 positive
    • No carcinoma of the neck of unknown primary site origin (even if p16 positive)
    • Cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx

      • Clinical evidence should be documented; may consist of palpation, imaging, or endoscopic evaluation; and should be sufficient to estimate the size of the primary (for T stage)
    • No distant metastasis or adenopathy below the clavicles
  • Patients must be positive for p16, determined by the OSU Innovation Center CLIA lab prior to step 2 registration (randomization)

    • Paraffin-embedded cytology specimens are acceptable for p16 evaluation, but cytology smears are not
  • Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations

    • Tonsillectomy or local excision of the primary without removal of nodal disease is permitted, as is excision removing gross nodal disease but with intact primary site
    • Limited neck dissections retrieving ≤ 4 nodes are permitted and considered as non-therapeutic nodal excisions
    • Fine-needle aspirations of the neck are insufficient due to limited tissue for retrospective central review
    • Biopsy specimens from the primary or nodes measuring at least 3-5 mm are required
  • Clinical stage T1-2 N2a-N3 or T3-4 any N, including no distant metastases
  • No clinical stage T1-2 N0-1
  • No simultaneous primaries or bilateral tumors

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin (Hgb) ≥ 8.0 g/dL (transfusion or other intervention to achieve Hgb ≥ 8.0 g/dL is acceptable)
  • Bilirubin ≤ 2 mg/dL
  • AST or ALT ≤ 3 times upper limit of normal
  • Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 50 mL/min
  • Negative pregnancy test
  • Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study, and until at least 60 days following the last study treatment
  • Patients who are HIV-positive and have no prior AIDS-defining illness and have CD4 cells of at least 340/mm³ are eligible

    • HIV status must be known prior to registration
    • No multidrug resistance for HIV infection
  • Not seropositive for hepatitis B (hepatitis B surface antigen positive or anti-hepatitis B core antigen positive) or hepatitis C (anti-hepatitis C antibody positive)

    • Immunity to hepatitis B (anti-hepatitis B surface antibody positive) allowed
  • No prior invasive malignancy except non-melanoma skin cancer, or malignancy for which the patient has been disease-free for at least 3 years (e.g., carcinoma in situ of the breast, oral cavity, or cervix)
  • No severe, active co-morbidity, defined as any of the following:

    • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
    • Transmural myocardial infarction within the last 6 months
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration
    • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

      • Laboratory tests for liver function and coagulation parameters are not required for entry into this protocol
    • Immunocompromised patients
  • No prior allergic reaction to cisplatin or cetuximab

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior systemic chemotherapy for the study cancer

    • Prior chemotherapy for a different cancer allowed
  • No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • No prior cetuximab or other anti-EGFR therapy
  • No concurrent amifostine as a radioprotector
  • No concurrent granulocyte colony-stimulating factor or erythropoietin
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302834

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Locations
United States, Alaska
Providence Cancer Center Recruiting
Anchorage, Alaska, United States, 99508
Contact: Clinical Trials Office - Providence Cancer Center    907-261-3109      
United States, California
Auburn Radiation Oncology Recruiting
Auburn, California, United States, 95603
Contact: Christopher Jones, MD    916-646-6600      
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center Recruiting
Burbank, California, United States, 91505
Contact: Clinical Trials Office - Providence Saint Joseph Medical Cente    818-847-3220      
Radiation Oncology Centers - Cameron Park Recruiting
Cameron Park, California, United States, 95682
Contact: Christopher Jones, MD    916-646-6600      
Mercy Cancer Center at Mercy San Juan Medical Center Recruiting
Carmichael, California, United States, 95608
Contact: Christopher Jones, MD    916-646-6600      
Enloe Cancer Center at Enloe Medical Center Recruiting
Chico, California, United States, 95926
Contact: Clinical Trials Office - Enloe Cancer Center at Enloe Medical    530-332-3808      
City of Hope Comprehensive Cancer Center Recruiting
Duarte, California, United States, 91010-3000
Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen    800-826-4673    becomingapatient@coh.org   
Rebecca and John Moores UCSD Cancer Center Recruiting
La Jolla, California, United States, 92093-0658
Contact: Clinical Trials Office - Rebecca and John Moores UCSD Cancer    858-822-5354    cancercto@ucsd.edu   
Kaiser Permanente - Division of Research - Oakland Recruiting
Oakland, California, United States, 94611
Contact: Louis Fehrenbacher, MD    707-651-2577      
Rohnert Park Cancer Center Recruiting
Rohnert Park, California, United States, 94928
Contact: Louis Fehrenbacher, MD    707-651-2577      
Radiation Oncology Center - Roseville Recruiting
Roseville, California, United States, 95661
Contact: Christopher Jones, MD    916-646-6600      
Mercy General Hospital Recruiting
Sacramento, California, United States, 95819
Contact: Christopher Jones, MD    916-646-6600      
Radiological Associates of Sacramento Medical Group, Incorporated Recruiting
Sacramento, California, United States, 95815
Contact: Christopher Jones, MD    916-646-6600      
UCSF Helen Diller Family Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94115
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi    877-827-3222      
Recruiting
Santa Clara, California, United States, 95051
Contact: Louis Fehrenbacher, MD    707-651-2577      
Kaiser Permanente Medical Center - South San Francisco Recruiting
South San Francisco, California, United States, 94080
Contact: Louis Fehrenbacher, MD    707-651-2577      
Solano Radiation Oncology Center Recruiting
Vacaville, California, United States, 95687
Contact: Christopher Jones, MD    916-646-6600      
United States, Colorado
Rocky Mountain Cancer Centers - Aurora Recruiting
Aurora, Colorado, United States, 80012
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
Boulder Community Hospital Recruiting
Boulder, Colorado, United States, 80301-9019
Contact: Clinical Trials Office - Boulder Community Hospital    303-938-5253      
Penrose Cancer Center at Penrose Hospital Recruiting
Colorado Springs, Colorado, United States, 80933
Contact: Clinical Trials Office - Penrose Cancer Center    719-776-5275      
Porter Adventist Hospital Recruiting
Denver, Colorado, United States, 80210
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
Swedish Medical Center Recruiting
Englewood, Colorado, United States, 80110
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
McKee Medical Center Recruiting
Loveland, Colorado, United States, 80539
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
North Suburban Medical Center Recruiting
Thornton, Colorado, United States, 80229
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
United States, Connecticut
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus Recruiting
New Britain, Connecticut, United States, 06050
Contact: Clinical Trials Office - George Bray Cancer Center    860-224-5660      
United States, Delaware
CCOP - Christiana Care Health Services Recruiting
Newark, Delaware, United States, 19713
Contact: Clinical Trial Office - CCOP - Christiana Care Health Services    302-623-4450      
United States, Florida
North Broward Medical Center Recruiting
Dearfield Beach, Florida, United States, 33064-3596
Contact: Clinical Trials Office - North Broward Medical Center    954-941-8300      
Baptist Cancer Institute - Jacksonville Recruiting
Jacksonville, Florida, United States, 32207
Contact: Clinical Trials Office - Baptist Cancer Institute - Jacksonvil    904-202-7051      
Integrated Community Oncology Network at Southside Cancer Center Recruiting
Jacksonville, Florida, United States, 32207
Contact: Michael R. Olson    904-636-6911      
Integrated Community Oncology Network Recruiting
Jacksonville Beach, Florida, United States, 32250
Contact: Michael R. Olson    904-363-2113      
Baptist Medical Center South Recruiting
Jascksonville, Florida, United States, 32258
Contact: Michael R. Olson    904-821-6000      
University of Miami Sylvester Comprehensive Cancer Center - Miami Recruiting
Miami, Florida, United States, 33136
Contact: University of Miami Sylvester Comprehensive Cancer Center Clin    866-574-5124    Sylvester@emergingmed.com   
Integrated Community Oncology Network - Orange Park Recruiting
Orange Park, Florida, United States, 32073
Contact: Michael R. Olson    904-272-3139      
Florida Hospital Cancer Institute at Florida Hospital Orlando Recruiting
Orlando, Florida, United States, 32803-1273
Contact: Clinical Trials Office - Florida Hospital Cancer Institute    407-303-5623      
M.D. Anderson Cancer Center at Orlando Recruiting
Orlando, Florida, United States, 32806
Contact: Rafael R. Manon    407-648-3800      
Florida Cancer Center - Palatka Recruiting
Palatka, Florida, United States, 32177
Contact: Michael R. Olson    386-325-8140      
Sacred Heart Cancer Center at Sacred Heart Hospital Recruiting
Pensacola, Florida, United States, 32504
Contact: Clinical Trials Office - Sacred Heart Cancer Center    850-416-4611      
Flagler Cancer Center Recruiting
Saint Augustine, Florida, United States, 32086
Contact: Michael R. Olson    904-824-5189      
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida Recruiting
Tampa, Florida, United States, 33612-9497
Contact: Clinical Trials Office - H. Lee Moffitt Cancer Center and Rese    800-456-7121    canceranswers@moffitt.org   
United States, Georgia
Winship Cancer Institute of Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Clinical Trials Office - Winship Cancer Institute    404-778-1900      
Georgia Cancer Center for Excellence at Grady Memorial Hospital Recruiting
Atlanta, Georgia, United States, 30303
Contact: Jonathan J. Beitler    404-489-9000      
Northeast Georgia Medical Center Recruiting
Gainesville, Georgia, United States, 30501
Contact: Frank G. Lake, MD    770-535-3393      
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Recruiting
Savannah, Georgia, United States, 31403-3089
Contact: Clinical Trials Office - Curtis and Elizabeth Anderson Cancer    912-350-8568      
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler Recruiting
Savannah, Georgia, United States, 31405
Contact: John A. Pablo    912-819-6000      
United States, Illinois
Northwest Community Hospital Recruiting
Arlington Heights, Illinois, United States, 60005
Contact: Stephen S. Nigh, MD    847-618-6560      
University of Chicago Cancer Research Center Recruiting
Chicago, Illinois, United States, 60637-1470
Contact: Clinical Trials Office - University of Chicago Cancer Research    773-834-7424      
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Recruiting
Chicago, Illinois, United States, 60611-3013
Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer    312-695-1301    cancer@northwestern.edu   
Creticos Cancer Center at Advocate Illinois Masonic Medical Center Recruiting
Chicago, Illinois, United States, 60657
Contact: Clinical Trials Office - Creticos Cancer Center at Advocate Il    773-296-5360      
John H. Stroger, Jr. Hospital of Cook County Recruiting
Chicago, Illinois, United States, 60612-3785
Contact: Fred R. Rosen, MD    312-864-7259      
Decatur Memorial Hospital Cancer Care Institute Recruiting
Decatur, Illinois, United States, 62526
Contact: Clinical Trials Office - Decatur Memorial Hospital Cancer Care    217-876-4750      
Evanston Hospital Recruiting
Evanston, Illinois, United States, 60201-1781
Contact: Clinical Trials Office - Evanston Hospital    847-570-1381      
Cardinal Bernardin Cancer Center at Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Clinical Trials Office - Cardinal Bernardin Cancer Center    708-226-4357      
Regional Cancer Center at Memorial Medical Center Recruiting
Springfield, Illinois, United States, 62781-0001
Contact: Clinical Trials Office - Regional Cancer Center at Memorial Me    217-788-4233      
Cancer Institute at St. John's Hospital Recruiting
Springfield, Illinois, United States, 62702
Contact: Cathy L. Clausen, MD    765-646-8358      
United States, Indiana
St. Francis Hospital and Health Centers - Beech Grove Campus Recruiting
Beech Grove, Indiana, United States, 46107
Contact: Howard M. Gross, MD    937-832-1093      
Elkhart General Hospital Recruiting
Elkhart, Indiana, United States, 46515
Contact: David A. Hornback, MD    574-647-7461      
Parkview Regional Cancer Center at Parkview Health Recruiting
Fort Wayne, Indiana, United States, 46805
Contact: Brian K. Chang    260-373-7850      
Center for Cancer Care at Goshen General Hospital Recruiting
Goshen, Indiana, United States, 46526
Contact: Clinical Trials Office - Center for Cancer Care at Goshen Gene    574-535-2858      
Community Regional Cancer Care at Community Hospital North Recruiting
Indianapolis, Indiana, United States, 46256
Contact: Shih J. Wei    317-621-4300      
Community Regional Cancer Care at Community Hospital East Recruiting
Indianapolis, Indiana, United States, 46219
Contact: Shih J. Wei    317-355-5347      
Michiana Hematology-Oncology, PC - South Bend Recruiting
Mishawaka, Indiana, United States, 46545-1470
Contact: David A. Hornback, MD    574-647-7461      
Cancer Center at Ball Memorial Hospital Recruiting
Muncie, Indiana, United States, 47303-3499
Contact: Clinical Trials Office - Cancer Center at Ball Memorial Hospit    765-281-2107      
Memorial Hospital of South Bend Recruiting
South Bend, Indiana, United States, 46601
Contact: Clinical Trials Office - Memorial Hospital of South Bend    800-284-7370      
United States, Iowa
McFarland Clinic, PC Recruiting
Ames, Iowa, United States, 50010
Contact: Clinical Trials Office - McFarland Clinic, PC    515-239-2621      
John Stoddard Cancer Center at Iowa Methodist Medical Center Recruiting
Des Moines, Iowa, United States, 50309
Contact: Clinical Trials Office - John Stoddard Cancer Center at Iowa M    515-241-6727      
Siouxland Hematology-Oncology Associates, LLP Recruiting
Sioux City, Iowa, United States, 51101
Contact: Donald B. Wender, MD, PhD    712-252-0088      
United States, Kansas
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160-7357
Contact: Clinical Trials Office - Kansas Masonic Cancer Research Instit    913-588-4709      
Kansas City Cancer Centers - Southwest Recruiting
Overland Park, Kansas, United States, 66210
Contact: Parvesh Kumar, MD    323-865-3072      
CCOP - Kansas City Recruiting
Prairie Village, Kansas, United States, 66208
Contact: Rakesh Gaur, MD    913-948-5588      
United States, Kentucky
Lucille P. Markey Cancer Center at University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536-0093
Contact: Clinical Trials Office - Markey Cancer Center at University of    859-257-3379      
James Graham Brown Cancer Center at University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Shiao Y. Woo    502-562-4158      
United States, Louisiana
Mary Bird Perkins Cancer Center - Baton Rouge Recruiting
Baton Rouge, Louisiana, United States, 70809
Contact: Robert W. Veith    225-767-0847      
CCOP - Ochsner Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Mini J. Elnaggar    504-842-3910      
United States, Maine
Maine Center for Cancer Medicine and Blood Disorders - Scarborough Recruiting
Scarborough, Maine, United States, 04074
Contact: Ian J. Bristol    207-885-7600      
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Clinical Trials Office - Greenebaum Cancer Center at Universit    800-888-8823      
St. Agnes Hospital Cancer Center Recruiting
Baltimore, Maryland, United States, 21229
Contact: Richard S. Hudes, MD    410-368-2965      
United States, Massachusetts
Lahey Clinic Medical Center - Burlington Recruiting
Burlington, Massachusetts, United States, 01805
Contact: Clinical Trials Office - Lahey Clinic Medical Center - Burling    781-744-8027      
NSMC Cancer Center - Peabody Recruiting
Danvers, Massachusetts, United States, 01923
Contact: Daniel E. Soto    978-977-3434      
Hudner Oncology Center at Saint Anne's Hospital - Fall River Recruiting
Fall River, Massachusetts, United States, 02721
Contact: Clinical Trials Office - Hudner Oncology Center at Saint Anne'    508-674-5600 ext 2019      
United States, Michigan
Saint Joseph Mercy Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48106-0995
Contact: Samir Narayan    734-712-5658      
Battle Creek Health System Cancer Care Center Recruiting
Battle Creek, Michigan, United States, 49017
Contact: Gilbert D.A. Padula    616-966-8000      
Josephine Ford Cancer Center at Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Eleanor M. Walker, MD    313-916-1021      
Genesys Hurley Cancer Institute Recruiting
Flint, Michigan, United States, 48503
Contact: Clinical Trials Office - Genesys Hurley Cancer Institute    810-762-8057      
Lacks Cancer Center at Saint Mary's Health Care Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Gilbert D.A. Padula    616-752-5222      
Butterworth Hospital at Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Gilbert D.A. Padula    616-391-2799      
United States, Minnesota
Mercy and Unity Cancer Center at Mercy Hospital Recruiting
Coon Rapids, Minnesota, United States, 55433
Contact: Paul Sperduto, MD, MAPP    952-442-6000      
Fairview Southdale Hospital Recruiting
Edina, Minnesota, United States, 55435
Contact: Clinical Trials Office - Fairview Southdale Hospital    612-625-3650      
Mercy and Unity Cancer Center at Unity Hospital Recruiting
Fridley, Minnesota, United States, 55432
Contact: Paul Sperduto, MD, MAPP    952-442-6000      
Park Nicollet Cancer Center Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Paul Sperduto, MD, MAPP    952-442-6000      
Regions Hospital Cancer Care Center Recruiting
St. Paul, Minnesota, United States, 55101
Contact: Clinical Trials Office - Regions Hospital Cancer Care Center    651-254-1517      
United States, Mississippi
Regional Cancer Center at Singing River Hospital Recruiting
Pascagoula, Mississippi, United States, 39581
Contact: James E. Clarkson, MD    228-374-6296      
United States, Missouri
Cancer Institute of Cape Girardeau, LLC Recruiting
Cape Girardeau, Missouri, United States, 63703
Contact: Tapan Roy, MD    573-334-2230      
Kansas City Cancer Centers - North Recruiting
Kansas City, Missouri, United States, 64154
Contact: Parvesh Kumar, MD    323-865-3072      
Kansas City Cancer Centers - South Recruiting
Kansas City, Missouri, United States, 64131
Contact: Parvesh Kumar, MD    323-865-3072      
CCOP - St. Louis-Cape Girardeau Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Bethany G. Sleckman, MD    314-251-7057      
David C. Pratt Cancer Center at St. John's Mercy Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Clinical Trials Office - David C. Pratt Cancer Center at St. J    314-251-6770      
Barnes-Jewish West County Hospital Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Wade L. Thorstad, MD    314-362-8516      
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Wade L. Thorstad, MD    314-362-8516      
Hulston Cancer Center at Cox Medical Center South Recruiting
Springfield, Missouri, United States, 65807
Contact: Robert L. Carolla    417-269-5257      
United States, Montana
Billings Clinic - Downtown Recruiting
Billings, Montana, United States, 59107-7000
Contact: Clinical Trials Office - Billings Clinic - Downtown    800-996-2663    research@billingsclinic.org   
United States, Nebraska
Methodist Estabrook Cancer Center Recruiting
Omaha, Nebraska, United States, 68114
Contact: Tien-Shew W. Huang    402-354-5890      
Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Weining K. Zhen, MD    402-552-3844      
United States, Nevada
Renown Institute for Cancer at Renown Regional Medical Center Recruiting
Reno, Nevada, United States, 89502
Contact: Daniel W. Weed    775-982-5050      
United States, New Hampshire
Payson Center for Cancer Care at Concord Hospital Recruiting
Concord, New Hampshire, United States, 03301
Contact: Su K. Metcalfe    603-225-2711      
Seacoast Cancer Center at Wentworth - Douglass Hospital Recruiting
Dover, New Hampshire, United States, 03820
Contact: Su K. Metcalfe    603-742-8787      
Kingsbury Center for Cancer Care at Cheshire Medical Center Recruiting
Keene, New Hampshire, United States, 03431
Contact: Alan C. Hartford, MD, PhD    603-650-6600      
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756-0002
Contact: Clinical Trials Office - Norris Cotton Cancer Center    603-650-7609    cancerhelp@dartmouth.edu   
United States, New Jersey
Monmouth Medical Center Recruiting
Long Branch, New Jersey, United States, 07740-6395
Contact: Clinical Trials Office - Monmouth Medical Center    732-923-7689      
Frederick R. and Betty M. Smith Cancer Treatment Center Recruiting
Sparta, New Jersey, United States, 07871
Contact: Voichita Bar Ad    973-726-4180      
Cancer Institute of New Jersey at Cooper - Voorhees Recruiting
Voorhees, New Jersey, United States, 08043
Contact: Clinical Trials Office - Cancer Institute of New Jersey at Coo    856-325-6757      
United States, New Mexico
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87131-5636
Contact: Clinical Trials Office - University of New Mexico Cancer Cente    505-272-6972      
United States, New York
Lourdes Regional Cancer Center Recruiting
Binghamton, New York, United States, 13905
Contact: Surjeet S. Pohar, MD    757-388-2075      
James P. Wilmot Cancer Center at University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Yuhchyau Chen    585-275-5345      
Highland Hospital of Rochester Recruiting
Rochester, New York, United States, 14620
Contact: Yuhchyau Chen    585-473-2200      
United States, North Carolina
Mission Hospitals - Memorial Campus Recruiting
Asheville, North Carolina, United States, 28801
Contact: Clinical Trials Office - Mission Hospitals - Memorial Campus    828-213-4150      
Blumenthal Cancer Center at Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28232-2861
Contact: Clinical Trials Office - Blumenthal Cancer Center at Carolinas    704-355-2884      
Moses Cone Regional Cancer Center at Wesley Long Community Hospital Recruiting
Greensboro, North Carolina, United States, 27403-1198
Contact: Clinical Trials Office - Moses Cone Regional Cancer Center at    336-621-8374      
Kinston Medical Specialists Recruiting
Kinston, North Carolina, United States, 28501
Contact: Peter R. Watson, MD    252-559-2200 ext 201      
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center Recruiting
Pinehurst, North Carolina, United States, 28374
Contact: Clinical Trials Office - FirstHealth Moore Regional Community    910-715-2200      
United States, Ohio
Summa Center for Cancer Care at Akron City Hospital Recruiting
Akron, Ohio, United States, 44309-2090
Contact: Clinical Trials Office - Akron City Hospital    330-375-6101      
Barberton Citizens Hospital Recruiting
Barberton, Ohio, United States, 44203
Contact: William F. Demas, MD    330-375-3557      
Charles M. Barrett Cancer Center at University Hospital Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Kevin P. Redmond, MD    513-584-9089      
Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106-5065
Contact: Clinical Trials Office - Case Comprehensive Cancer Center    800-641-2422      
Cleveland Clinic Taussig Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente    866-223-8100      
Cleveland Clinic Cancer Center at Fairview Hospital Recruiting
Cleveland, Ohio, United States, 44111
Contact: Clinical Trials Office - Cleveland Clinic Cancer Center at Fai    216-476-9362      
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210-1240
Contact: Ohio State University Cancer Clinical Trial Matching Service    866-627-7616    Jamesline@osumc.edu   
Northwest Ohio Oncology Center Recruiting
Maumee, Ohio, United States, 43537-1839
Contact: Rex B. Mowat    419-891-5600      
Hillcrest Cancer Center at Hillcrest Hospital Recruiting
Mayfield Heights, Ohio, United States, 44124
Contact: David J. Adelstein    440-312-4500      
Lake/University Ireland Cancer Center Recruiting
Mentor, Ohio, United States, 44060
Contact: Min Yao    440-205-5755      
Southwest General Health Center Recruiting
Middleburg Heights, Ohio, United States, 44130
Contact: Min Yao    440-816-8000      
St. Charles Mercy Hospital Recruiting
Oregon, Ohio, United States, 43616
Contact: Rex B. Mowat    419-696-7200      
Flower Hospital Cancer Center Recruiting
Sylvania, Ohio, United States, 43560
Contact: Clinical Trials Office - Flower Hospital Cancer Center    419-824-1842      
St. Anne Mercy Hospital Recruiting
Toledo, Ohio, United States, 43623
Contact: Rex B. Mowat    419-407-2663      
Precision Radiotherapy at University Pointe Recruiting
West Chester, Ohio, United States, 45069
Contact: Kevin P. Redmond, MD    513-584-9089      
UHHS Westlake Medical Center Recruiting
Westlake, Ohio, United States, 44145
Contact: Min Yao    440-250-2001      
Cancer Treatment Center Recruiting
Wooster, Ohio, United States, 44691
Contact: Clinical Trials Office - Cancer Treatment Center    330-375-4221      
United States, Oklahoma
Oklahoma University Cancer Institute Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Terence S. Herman    405-271-6822      
Natalie Warren Bryant Cancer Center at St. Francis Hospital Recruiting
Tulsa, Oklahoma, United States, 74136
Contact: Charles E. Stewart    918-494-2273      
United States, Oregon
Clackamas Radiation Oncology Center Recruiting
Clackamas, Oregon, United States, 97015
Contact: Matthew C. Solhjem    503-513-3300      
Dubs Cancer Center at Rogue Valley Medical Center Recruiting
Medford, Oregon, United States, 97504
Contact: Gordon L. Metz, MD    541-608-4263      
Providence Cancer Center at PMCC Recruiting
Medford, Oregon, United States, 97504
Contact: Gordon L. Metz, MD    541-608-4263      
Knight Cancer Institute at Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239-3098
Contact: Clinical Trials Office - Knight Cancer Institute at Oregon Hea    503-494-1080    trials@ohsu.edu   
Providence Cancer Center at Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213-2967
Contact: Clinical Trials Office - Providence Cancer Center at Providenc    503-215-6412      
Providence St. Vincent Medical Center Recruiting
Portland, Oregon, United States, 97225
Contact: Clinical Trials Office - Providence St. Vincent Medical Center    503-215-6412      
United States, Pennsylvania
Rosenfeld Cancer Center at Abington Memorial Hospital Recruiting
Abington, Pennsylvania, United States, 19001
Contact: Clinical Trials Office - Rosenfeld Cancer Center at Abington M    215-481-2402      
Dale and Frances Hughes Cancer Center at Pocono Medical Center Recruiting
East Stroudsburg, Pennsylvania, United States, 18301
Contact: Voichita Bar Ad    570-476-3488      
Adams Cancer Center Recruiting
Gettysburg, Pennsylvania, United States, 17325
Contact: Amit B. Shah    717-741-8180      
Cherry Tree Cancer Center Recruiting
Hanover, Pennsylvania, United States, 17331
Contact: Amit B. Shah    717-741-8180      
St. Mary Regional Cancer Center Recruiting
Langhorne, Pennsylvania, United States, 19047
Contact: Clinical Trials Office - St. Mary Regional Cancer Center    215-710-4585      
Fox Chase Cancer Center - Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19111-2497
Contact: Clinical Trials Office - Fox Chase Cancer Center - Philadelphi    215-728-4790      
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center Recruiting
Reading, Pennsylvania, United States, 19612-6052
Contact: Clinical Trials Office - McGlinn Family Regional Cancer Center    610-988-9323      
York Cancer Center at Apple Hill Medical Center Recruiting
York, Pennsylvania, United States, 17405
Contact: Amit B. Shah    717-741-8180      
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Clinical Trials Office - Hollings Cancer Center at Medical Uni    843-792-9321      
Cancer Centers of the Carolinas - Faris Road Recruiting
Greenville, South Carolina, United States, 29605
Contact: David L. Grisell    864-679-3900      
CCOP - Greenville Recruiting
Greenville, South Carolina, United States, 29615
Contact: David L. Grisell    864-241-6251      
Cancer Centers of the Carolinas - Spartanburg Recruiting
Spartanburg, South Carolina, United States, 29307
Contact: David L. Grisell    864-699-5700      
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Recruiting
Spartanburg, South Carolina, United States, 29303
Contact: Clinical Trials Office - Gibbs Regional Cancer Center    800-486-5941      
United States, South Dakota
Rapid City Regional Hospital Recruiting
Rapid City, South Dakota, United States, 57701
Contact: Michael J. Swartz    605-719-2360      
United States, Tennessee
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232-6838
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center    800-811-8480      
United States, Texas
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555-0361
Contact: Clinical Trials Office - University of Texas Medical Branch    409-772-1950      
M. D. Anderson Cancer Center at University of Texas Recruiting
Houston, Texas, United States, 77030-4009
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U    713-792-3245      
United States, Utah
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center Recruiting
Murray, Utah, United States, 84157
Contact: Vilija N. Avizonis    801-507-3800      
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center Recruiting
Ogden, Utah, United States, 84403
Contact: Clinical Trials Office - McKay-Dee Hospital Center    801-387-7426      
Utah Valley Regional Medical Center - Provo Recruiting
Provo, Utah, United States, 84604
Contact: Clinical Trials Office - Utah Valley Regional Medical Center -    801-357-7965      
Huntsman Cancer Institute at University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Clinical Trials Office - Huntsman Cancer Institute at Universi    801-581-4477    clinical.trials@hci.utah.edu   
Utah Cancer Specialists at UCS Cancer Center Recruiting
Salt Lake City, Utah, United States, 84106
Contact: Vilija N. Avizonis    801-269-0231      
United States, Virginia
Sentara Cancer Institute at Sentara Norfolk General Hospital Recruiting
Norfolk, Virginia, United States, 23507
Contact: Clinical Trials Office - Sentara Cancer Institute at Sentara N    757-388-2406      
Coastal Cancer Center at Sentara Virginia Beach General Hospital Recruiting
Virginia Beach, Virginia, United States, 23454
Contact: Scott S. Williams    757-395-8686      
United States, Washington
St. Joseph Cancer Center Recruiting
Bellingham, Washington, United States, 98225
Contact: Michael A. Taylor, MD    360-715-4144      
CCOP - Virginia Mason Research Center Recruiting
Seattle, Washington, United States, 98101
Contact: Huong T. Pham, MD    206-223-6801      
Northwest Cancer Specialists at Vancouver Cancer Center Recruiting
Vancouver, Washington, United States, 98684
Contact: Matthew C. Solhjem    360-944-9889      
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Recruiting
Yakima, Washington, United States, 98902
Contact: Clinical Trails Office - North Star Lodge Cancer Center    509-574-3422      
United States, West Virginia
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital Recruiting
Huntington, West Virginia, United States, 25701
Contact: Oncology Research Supervisor    304-399-6617      
Schiffler Cancer Center at Wheeling Hospital Recruiting
Wheeling, West Virginia, United States, 26003
Contact: Jon D. Pollock, MD    304-243-3490      
United States, Wisconsin
Theda Care Cancer Institute Recruiting
Appleton, Wisconsin, United States, 54911
Contact: Clinical Trials Office - Theda Care Cancer Institute    920-380-1500      
St. Vincent Hospital Regional Cancer Center Recruiting
Green Bay, Wisconsin, United States, 54307-3508
Contact: Clinical Trials Office - St. Vincent Hospital Regional Cancer    920-433-8889      
St. Mary's Hospital Medical Center - Green Bay Recruiting
Green Bay, Wisconsin, United States, 54303
Contact: Gregory M. Cooley, MD    414-433-8184      
Gundersen Lutheran Center for Cancer and Blood Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Clinical Trials Office - Gundersen Lutheran Cancer Center    608-775-2385    cancerctr@gundluth.org   
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Recruiting
Madison, Wisconsin, United States, 53792-6164
Contact: Clinical Trials Office - University of Wisconsin Paul P. Carbo    608-262-5223      
Bay Area Cancer Care Center at Bay Area Medical Center Recruiting
Marinette, Wisconsin, United States, 54143
Contact: Gregory M. Cooley, MD    414-433-8184      
Medical College of Wisconsin Cancer Center Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Clinical Trials Office - Medical College of Wisconsin Cancer C    414-805-4380      
Veterans Affairs Medical Center - Milwaukee Recruiting
Milwaukee, Wisconsin, United States, 53295
Contact: Elizabeth M. Gore, MD    414-805-4369      
University of Wisconcin Cancer Center at Aspirus Wausau Hospital Recruiting
Wausau, Wisconsin, United States, 54401
Contact: Clinical Trials Office - University of Wisconsin Cancer Center    608-262-5223      
Canada, Manitoba
CancerCare Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: James B. Butler, MD    204-787-1400      
Canada, Quebec
McGill Cancer Centre at McGill University Recruiting
Montreal, Quebec, Canada, H2W 1S6
Contact: George Shenouda    514-398-1444      
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Principal Investigator: Andy M. Trotti, MD H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT01302834     History of Changes
Other Study ID Numbers: RTOG-1016, CDR0000695731
Study First Received: February 22, 2011
Last Updated: January 6, 2014
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
stage III squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx
human papilloma virus infection

Additional relevant MeSH terms:
Head and Neck Neoplasms
Precancerous Conditions
Oropharyngeal Neoplasms
Neoplasms by Site
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Cetuximab
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 23, 2014