Radiation Therapy With Cisplatin or Cetuximab in Treating Patients With Oropharyngeal Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT01302834
First received: February 22, 2011
Last updated: August 4, 2014
Last verified: August 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
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: NCT01302834

  Hide Study Locations
Locations
United States, Alaska
Providence Cancer Center
Anchorage, Alaska, United States, 99508
United States, California
Auburn Radiation Oncology
Auburn, California, United States, 95603
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
Burbank, California, United States, 91505
Radiation Oncology Centers - Cameron Park
Cameron Park, California, United States, 95682
Mercy Cancer Center at Mercy San Juan Medical Center
Carmichael, California, United States, 95608
Enloe Cancer Center at Enloe Medical Center
Chico, California, United States, 95926
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0658
Kaiser Permanente - Division of Research - Oakland
Oakland, California, United States, 94611
Rohnert Park Cancer Center
Rohnert Park, California, United States, 94928
Radiation Oncology Center - Roseville
Roseville, California, United States, 95661
Mercy General Hospital
Sacramento, California, United States, 95819
Radiological Associates of Sacramento Medical Group, Incorporated
Sacramento, California, United States, 95815
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
Santa Clara, California, United States, 95051
Kaiser Permanente Medical Center - South San Francisco
South San Francisco, California, United States, 94080
Solano Radiation Oncology Center
Vacaville, California, United States, 95687
United States, Colorado
Rocky Mountain Cancer Centers - Aurora
Aurora, Colorado, United States, 80012
Boulder Community Hospital
Boulder, Colorado, United States, 80301-9019
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States, 80933
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Swedish Medical Center
Englewood, Colorado, United States, 80110
McKee Medical Center
Loveland, Colorado, United States, 80539
North Suburban Medical Center
Thornton, Colorado, United States, 80229
United States, Connecticut
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
New Britain, Connecticut, United States, 06050
United States, Delaware
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, Florida
North Broward Medical Center
Dearfield Beach, Florida, United States, 33064-3596
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, United States, 32207
Integrated Community Oncology Network at Southside Cancer Center
Jacksonville, Florida, United States, 32207
Integrated Community Oncology Network
Jacksonville Beach, Florida, United States, 32250
Baptist Medical Center South
Jascksonville, Florida, United States, 32258
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136
Integrated Community Oncology Network - Orange Park
Orange Park, Florida, United States, 32073
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando, Florida, United States, 32803-1273
M.D. Anderson Cancer Center at Orlando
Orlando, Florida, United States, 32806
Florida Cancer Center - Palatka
Palatka, Florida, United States, 32177
Sacred Heart Cancer Center at Sacred Heart Hospital
Pensacola, Florida, United States, 32504
Flagler Cancer Center
Saint Augustine, Florida, United States, 32086
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States, 33612-9497
United States, Georgia
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
Georgia Cancer Center for Excellence at Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
Savannah, Georgia, United States, 31405
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States, 31403-3089
United States, Illinois
Northwest Community Hospital
Arlington Heights, Illinois, United States, 60005
Creticos Cancer Center at Advocate Illinois Masonic Medical Center
Chicago, Illinois, United States, 60657
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, United States, 60612-3785
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Evanston Hospital
Evanston, Illinois, United States, 60201-1781
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
Cancer Institute at St. John's Hospital
Springfield, Illinois, United States, 62702
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, United States, 62781-0001
United States, Indiana
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States, 46107
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Parkview Regional Cancer Center at Parkview Health
Fort Wayne, Indiana, United States, 46805
Center for Cancer Care at Goshen General Hospital
Goshen, Indiana, United States, 46526
Community Regional Cancer Care at Community Hospital East
Indianapolis, Indiana, United States, 46219
Community Regional Cancer Care at Community Hospital North
Indianapolis, Indiana, United States, 46256
Michiana Hematology-Oncology, PC - South Bend
Mishawaka, Indiana, United States, 46545-1470
Cancer Center at Ball Memorial Hospital
Muncie, Indiana, United States, 47303-3499
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
United States, Iowa
McFarland Clinic, PC
Ames, Iowa, United States, 50010
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101
United States, Kansas
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
Kansas City Cancer Centers - Southwest
Overland Park, Kansas, United States, 66210
CCOP - Kansas City
Prairie Village, Kansas, United States, 66208
United States, Kentucky
Lucille P. Markey Cancer Center at University of Kentucky
Lexington, Kentucky, United States, 40536-0093
James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States, 40202
United States, Louisiana
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge, Louisiana, United States, 70809
CCOP - Ochsner
New Orleans, Louisiana, United States, 70121
United States, Maine
Maine Center for Cancer Medicine and Blood Disorders - Scarborough
Scarborough, Maine, United States, 04074
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
St. Agnes Hospital Cancer Center
Baltimore, Maryland, United States, 21229
United States, Massachusetts
Lahey Clinic Medical Center - Burlington
Burlington, Massachusetts, United States, 01805
NSMC Cancer Center - Peabody
Danvers, Massachusetts, United States, 01923
Hudner Oncology Center at Saint Anne's Hospital - Fall River
Fall River, Massachusetts, United States, 02721
United States, Michigan
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, United States, 48106-0995
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, United States, 49017
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, United States, 49503
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, United States, 55416
Regions Hospital Cancer Care Center
St. Paul, Minnesota, United States, 55101
United States, Mississippi
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, United States, 39581
United States, Missouri
Cancer Institute of Cape Girardeau, LLC
Cape Girardeau, Missouri, United States, 63703
Kansas City Cancer Centers - North
Kansas City, Missouri, United States, 64154
Kansas City Cancer Centers - South
Kansas City, Missouri, United States, 64131
Barnes-Jewish West County Hospital
Saint Louis, Missouri, United States, 63141
CCOP - St. Louis-Cape Girardeau
Saint Louis, Missouri, United States, 63141
David C. Pratt Cancer Center at St. John's Mercy
Saint Louis, Missouri, United States, 63141
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis, Missouri, United States, 63110
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States, 65807
United States, Montana
Billings Clinic - Downtown
Billings, Montana, United States, 59107-7000
United States, Nebraska
Methodist Estabrook Cancer Center
Omaha, Nebraska, United States, 68114
Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, Nevada
Renown Institute for Cancer at Renown Regional Medical Center
Reno, Nevada, United States, 89502
United States, New Hampshire
Payson Center for Cancer Care at Concord Hospital
Concord, New Hampshire, United States, 03301
Seacoast Cancer Center at Wentworth - Douglass Hospital
Dover, New Hampshire, United States, 03820
Kingsbury Center for Cancer Care at Cheshire Medical Center
Keene, New Hampshire, United States, 03431
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New Jersey
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740-6395
Frederick R. and Betty M. Smith Cancer Treatment Center
Sparta, New Jersey, United States, 07871
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees, New Jersey, United States, 08043
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131-5636
United States, New York
Lourdes Regional Cancer Center
Binghamton, New York, United States, 13905
Highland Hospital of Rochester
Rochester, New York, United States, 14620
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States, 28801
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
Greensboro, North Carolina, United States, 27403-1198
Kinston Medical Specialists
Kinston, North Carolina, United States, 28501
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
Pinehurst, North Carolina, United States, 28374
United States, Ohio
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, United States, 44309-2090
Barberton Citizens Hospital
Barberton, Ohio, United States, 44203
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45267
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland, Ohio, United States, 44111
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210-1240
Northwest Ohio Oncology Center
Maumee, Ohio, United States, 43537-1839
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, United States, 44124
Lake/University Ireland Cancer Center
Mentor, Ohio, United States, 44060
Southwest General Health Center
Middleburg Heights, Ohio, United States, 44130
St. Charles Mercy Hospital
Oregon, Ohio, United States, 43616
Flower Hospital Cancer Center
Sylvania, Ohio, United States, 43560
St. Anne Mercy Hospital
Toledo, Ohio, United States, 43623
Precision Radiotherapy at University Pointe
West Chester, Ohio, United States, 45069
UHHS Westlake Medical Center
Westlake, Ohio, United States, 44145
Cancer Treatment Center
Wooster, Ohio, United States, 44691
United States, Oklahoma
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States, 73104
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States, 97015
Providence Cancer Center at PMCC
Medford, Oregon, United States, 97504
Dubs Cancer Center at Rogue Valley Medical Center
Medford, Oregon, United States, 97504
Knight Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97239-3098
Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States, 97213-2967
United States, Pennsylvania
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Dale and Frances Hughes Cancer Center at Pocono Medical Center
East Stroudsburg, Pennsylvania, United States, 18301
Adams Cancer Center
Gettysburg, Pennsylvania, United States, 17325
Cherry Tree Cancer Center
Hanover, Pennsylvania, United States, 17331
St. Mary Regional Cancer Center
Langhorne, Pennsylvania, United States, 19047
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
York Cancer Center at Apple Hill Medical Center
York, Pennsylvania, United States, 17405
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
CCOP - Greenville
Greenville, South Carolina, United States, 29615
Cancer Centers of the Carolinas - Faris Road
Greenville, South Carolina, United States, 29605
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
Cancer Centers of the Carolinas - Spartanburg
Spartanburg, South Carolina, United States, 29307
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0361
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
United States, Utah
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Murray, Utah, United States, 84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States, 84604
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, United States, 84106
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States, 84112
United States, Virginia
Sentara Cancer Institute at Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Coastal Cancer Center at Sentara Virginia Beach General Hospital
Virginia Beach, Virginia, United States, 23454
United States, Washington
St. Joseph Cancer Center
Bellingham, Washington, United States, 98225
CCOP - Virginia Mason Research Center
Seattle, Washington, United States, 98101
Northwest Cancer Specialists at Vancouver Cancer Center
Vancouver, Washington, United States, 98684
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, United States, 98902
United States, West Virginia
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
Huntington, West Virginia, United States, 25701
Schiffler Cancer Center at Wheeling Hospital
Wheeling, West Virginia, United States, 26003
United States, Wisconsin
Theda Care Cancer Institute
Appleton, Wisconsin, United States, 54911
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States, 54303
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, United States, 54601
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Veterans Affairs Medical Center - Milwaukee
Milwaukee, Wisconsin, United States, 53295
University of Wisconcin Cancer Center at Aspirus Wausau Hospital
Wausau, Wisconsin, United States, 54401
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Quebec
McGill Cancer Centre at McGill University
Montreal, Quebec, Canada, H2W 1S6
Sponsors and Collaborators
Radiation Therapy Oncology Group
NRG Oncology
Investigators
Principal Investigator: Andy M. Trotti, MD H. Lee Moffitt Cancer Center and Research Institute
Principal Investigator: Maura Gillison, MD, PhD Ohio State University
  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, NCI-2011-02638
Study First Received: February 22, 2011
Last Updated: August 4, 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
Neoplasms
Neoplasms by Site
Cetuximab
Cisplatin
Antineoplastic Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014