AzTrials
AzTrials

Head and Neck CancerPhase 3NCT01302834

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

A Phase 3 study testing cetuximab, cisplatin and IMRT in people with Head and Neck Cancer and Precancerous Condition, run by Radiation Therapy Oncology Group at 185 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Head and Neck Cancer, Precancerous Condition
What is being tested?
cetuximab, cisplatin and IMRT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
987 participants
Where
185 sitesin 2 countries
Study dates
Jun 2011to 4 Sep 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
  • Patients must be positive for p16, determined by central review prior to randomization.
  • 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 (AJCC, 7th ed.; see Appendix III), including no distant metastases, based upon the following minimum diagnostic workup:
  • General history and physical examination by a radiation oncologist and medical oncologist within 8 weeks prior to registration;
  • Examination by an ear, nose, and throat (ENT) or head and neck surgeon, including laryngopharyngoscopy (mirror and/or fiberoptic and/or direct procedure) within 8 weeks prior to registration;
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  • One of the following combinations of imaging is required within 8 weeks prior to registration:
  • A computerized tomography (CT) scan of the neck (with contrast) and a chest CT scan (with or without contrast);
  • or a magnetic resonance imaging (MRI) scan of the neck (with contrast) and a chest CT scan (with or without contrast);
  • or a CT scan of neck (with contrast) and a positron emission tomography (PET)/CT of neck and chest (with or without contrast);
  • or an MRI of the neck (with contrast) and a PET/CT of neck and chest (with or without contrast).
  • Note: A CT scan of neck and/or a PET/CT performed for radiation planning and read by a radiologist may serve as both staging and planning tools.
  • Zubrod Performance Status 0-1 within 2 weeks prior to registration
  • Age ≥ 18;
  • Complete blood count (CBC)/differential obtained within 2 weeks prior to registration on study, with adequate bone marrow function, defined as follows:
  • Absolute neutrophil count (ANC) > 1,500 cells/mm3;
  • Platelets > 100,000 cells/mm3;
  • Hemoglobin (Hgb) > 8.0 g/dl; Note: The use of transfusion or other intervention to achieve Hgb > 8.0 g/dl is acceptable.
  • Adequate hepatic function, defined as follows:
  • Bilirubin < 2 mg/dl within 2 weeks prior to registration;
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x the upper limit of normal within 2 weeks prior to registration;
  • Adequate renal function, defined as follows:
  • Serum creatinine < 1.5 mg/dl within 2 weeks prior to registration or creatinine clearance (CCr) ≥ 50 ml/min within 2 weeks prior to registration determined by 24-hour collection or estimated by Cockcroft-Gault formula:
  • CCr male = [(140 - age) x (wt in kg)] [(Serum Cr mg/dl) x (72)] CCr female = 0.85 x (CCr male)
  • Patients must provide their smoking history (for stratification) via the computer-assisted self interview (CASI) head and neck risk factor survey tool.
  • Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential;
  • 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 human immunodeficiency virus (HIV) positive but have no prior acquired immune deficiency syndrome (AIDS) -defining illness and have CD4 cells of at least 350/mm3 are eligible. Patient HIV status must be known prior to registration. Patients must not be sero-positive for Hepatitis B (Hepatitis B surface antigen positive or anti-hepatitis B core antigen positive) or sero-positive for Hepatitis C (anti-Hepatitis C antibody positive). However, patients who are immune to hepatitis B (anti-Hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B). HIV-positive patients must not have multi-drug resistant HIV infection or other concurrent AIDS-defining conditions.
  • Patient must provide study specific informed consent prior to study entry, including consent for mandatory submission of tissue for required, central p16 review and consent to participate in the computer-assisted self interview (CASI) survey questions regarding smoking history.

Who cannot join

  • Cancers considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), nasopharynx, hypopharynx, or larynx, even if p16 positive, are excluded. Carcinoma of the neck of unknown primary site origin (even if p16 positive) are excluded from participation.
  • Stage T1-2, N0-1;
  • Distant metastasis or adenopathy below the clavicles;
  • Gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease.
  • Simultaneous primaries or bilateral tumors;
  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible);
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  • Prior systemic chemotherapy 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:
  • 9.1 Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
  • 9.2 Transmural myocardial infarction within the last 6 months;
  • 9.3 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
  • 9.4 Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration;
  • 9.5 Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol.
  • 9.6 Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition with immune compromise greater than that noted in Section 3.1.13; note, however, that 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.
  • 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 cisplatin or cetuximab;
  • Prior cetuximab or other anti-EGFR therapy.

Trial locations and contacts

185 sites in 2 countries.

185 sites in 2 countries

United States183 sites

  • Rosenfeld Cancer Center at Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Summa Center for Cancer Care at Akron City Hospital

    Akron, Ohio, 44309-2090

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87131-5636

  • McFarland Clinic, PC

    Ames, Iowa, 50010

  • Providence Cancer Center

    Anchorage, Alaska, 99508

  • Saint Joseph Mercy Cancer Center

    Ann Arbor, Michigan, 48106-0995

  • Theda Care Cancer Institute

    Appleton, Wisconsin, 54911

  • Northwest Community Hospital

    Arlington Heights, Illinois, 60005

  • Mission Hospitals - Memorial Campus

    Asheville, North Carolina, 28801

  • Georgia Cancer Center for Excellence at Grady Memorial Hospital

    Atlanta, Georgia, 30303

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

  • Auburn Radiation Oncology

    Auburn, California, 95603

  • Rocky Mountain Cancer Centers - Aurora

    Aurora, Colorado, 80012

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • St. Agnes Hospital Cancer Center

    Baltimore, Maryland, 21229

  • Barberton Citizens Hospital

    Barberton, Ohio, 44203

  • Mary Bird Perkins Cancer Center - Baton Rouge

    Baton Rouge, Louisiana, 70809

  • Battle Creek Health System Cancer Care Center

    Battle Creek, Michigan, 49017

  • St. Francis Hospital and Health Centers - Beech Grove Campus

    Beech Grove, Indiana, 46107

  • St. Joseph Cancer Center

    Bellingham, Washington, 98225

  • Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Lourdes Regional Cancer Center

    Binghamton, New York, 13905

  • Boulder Community Hospital

    Boulder, Colorado, 80301-9019

  • Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center

    Burbank, California, 91505

  • Lahey Clinic Medical Center - Burlington

    Burlington, Massachusetts, 01805

  • Radiation Oncology Centers - Cameron Park

    Cameron Park, California, 95682

  • Cancer Institute of Cape Girardeau, LLC

    Cape Girardeau, Missouri, 63703

  • Mercy Cancer Center at Mercy San Juan Medical Center

    Carmichael, California, 95608

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Blumenthal Cancer Center at Carolinas Medical Center

    Charlotte, North Carolina, 28232-2861

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611-3013

  • John H. Stroger, Jr. Hospital of Cook County

    Chicago, Illinois, 60612-3785

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Creticos Cancer Center at Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

  • Enloe Cancer Center at Enloe Medical Center

    Chico, California, 95926

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

  • Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106-5065

  • Cleveland Clinic Cancer Center at Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Penrose Cancer Center at Penrose Hospital

    Colorado Springs, Colorado, 80933

  • Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210-1240

  • Payson Center for Cancer Care at Concord Hospital

    Concord, New Hampshire, 03301

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • NSMC Cancer Center - Peabody

    Danvers, Massachusetts, 01923

  • North Broward Medical Center

    Dearfield Beach, Florida, 33064-3596

  • Decatur Memorial Hospital Cancer Care Institute

    Decatur, Illinois, 62526

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • John Stoddard Cancer Center at Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • Seacoast Cancer Center at Wentworth - Douglass Hospital

    Dover, New Hampshire, 03820

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

  • Dale and Frances Hughes Cancer Center at Pocono Medical Center

    East Stroudsburg, Pennsylvania, 18301

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Swedish Medical Center

    Englewood, Colorado, 80110

  • Evanston Hospital

    Evanston, Illinois, 60201-1781

  • Hudner Oncology Center at Saint Anne's Hospital - Fall River

    Fall River, Massachusetts, 02721

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Parkview Regional Cancer Center at Parkview Health

    Fort Wayne, Indiana, 46805

  • Mercy and Unity Cancer Center at Unity Hospital

    Fridley, Minnesota, 55432

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0361

  • Adams Cancer Center

    Gettysburg, Pennsylvania, 17325

  • Center for Cancer Care at Goshen General Hospital

    Goshen, Indiana, 46526

  • Butterworth Hospital at Spectrum Health

    Grand Rapids, Michigan, 49503

  • Lacks Cancer Center at Saint Mary's Health Care

    Grand Rapids, Michigan, 49503

  • St. Mary's Hospital Medical Center - Green Bay

    Green Bay, Wisconsin, 54303

  • St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54307-3508

  • Moses Cone Regional Cancer Center at Wesley Long Community Hospital

    Greensboro, North Carolina, 27403-1198

  • Cancer Centers of the Carolinas - Faris Road

    Greenville, South Carolina, 29605

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Cherry Tree Cancer Center

    Hanover, Pennsylvania, 17331

  • M. D. Anderson Cancer Center at University of Texas

    Houston, Texas, 77030-4009

  • Edwards Comprehensive Cancer Center at Cabell Huntington Hospital

    Huntington, West Virginia, 25701

  • Community Regional Cancer Care at Community Hospital East

    Indianapolis, Indiana, 46219

  • Community Regional Cancer Care at Community Hospital North

    Indianapolis, Indiana, 46256

  • Baptist Cancer Institute - Jacksonville

    Jacksonville, Florida, 32207

  • Integrated Community Oncology Network at Southside Cancer Center

    Jacksonville, Florida, 32207

  • Integrated Community Oncology Network

    Jacksonville Beach, Florida, 32250

  • Baptist Medical Center South

    Jascksonville, Florida, 32258

  • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

    Kansas City, Kansas, 66160-7357

  • Kansas City Cancer Centers - South

    Kansas City, Missouri, 64131

  • Kansas City Cancer Centers - North

    Kansas City, Missouri, 64154

  • Kingsbury Center for Cancer Care at Cheshire Medical Center

    Keene, New Hampshire, 03431

  • Kinston Medical Specialists

    Kinston, North Carolina, 28501

  • Gundersen Lutheran Center for Cancer and Blood

    La Crosse, Wisconsin, 54601

  • Rebecca and John Moores UCSD Cancer Center

    La Jolla, California, 92093-0658

  • St. Mary Regional Cancer Center

    Langhorne, Pennsylvania, 19047

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0002

  • Lucille P. Markey Cancer Center at University of Kentucky

    Lexington, Kentucky, 40536-0093

  • Monmouth Medical Center

    Long Branch, New Jersey, 07740-6395

  • James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40202

  • McKee Medical Center

    Loveland, Colorado, 80539

  • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

    Madison, Wisconsin, 53792-6164

  • Bay Area Cancer Care Center at Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • Northwest Ohio Oncology Center

    Maumee, Ohio, 43537-1839

  • Hillcrest Cancer Center at Hillcrest Hospital

    Mayfield Heights, Ohio, 44124

  • Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Maywood, Illinois, 60153

  • Dubs Cancer Center at Rogue Valley Medical Center

    Medford, Oregon, 97504

  • Providence Cancer Center at PMCC

    Medford, Oregon, 97504

  • Lake/University Ireland Cancer Center

    Mentor, Ohio, 44060

  • University of Miami Sylvester Comprehensive Cancer Center - Miami

    Miami, Florida, 33136

  • Southwest General Health Center

    Middleburg Heights, Ohio, 44130

  • Medical College of Wisconsin Cancer Center

    Milwaukee, Wisconsin, 53226

  • Veterans Affairs Medical Center - Milwaukee

    Milwaukee, Wisconsin, 53295

  • Michiana Hematology-Oncology, PC - South Bend

    Mishawaka, Indiana, 46545-1470

  • Cancer Center at Ball Memorial Hospital

    Muncie, Indiana, 47303-3499

  • Jon and Karen Huntsman Cancer Center at Intermountain Medical Center

    Murray, Utah, 84157

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232-6838

  • George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus

    New Britain, Connecticut, 06050

  • CCOP - Ochsner

    New Orleans, Louisiana, 70121

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • Sentara Cancer Institute at Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • Kaiser Permanente - Division of Research - Oakland

    Oakland, California, 94611

  • Val and Ann Browning Cancer Center at McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • Oklahoma University Cancer Institute

    Oklahoma City, Oklahoma, 73104

  • Methodist Estabrook Cancer Center

    Omaha, Nebraska, 68114

  • Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Integrated Community Oncology Network - Orange Park

    Orange Park, Florida, 32073

  • St. Charles Mercy Hospital

    Oregon, Ohio, 43616

  • Florida Hospital Cancer Institute at Florida Hospital Orlando

    Orlando, Florida, 32803-1273

  • M.D. Anderson Cancer Center at Orlando

    Orlando, Florida, 32806

  • Kansas City Cancer Centers - Southwest

    Overland Park, Kansas, 66210

  • Florida Cancer Center - Palatka

    Palatka, Florida, 32177

  • Regional Cancer Center at Singing River Hospital

    Pascagoula, Mississippi, 39581

  • Sacred Heart Cancer Center at Sacred Heart Hospital

    Pensacola, Florida, 32504

  • Fox Chase Cancer Center - Philadelphia

    Philadelphia, Pennsylvania, 19111-2497

  • FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center

    Pinehurst, North Carolina, 28374

  • Providence Cancer Center at Providence Portland Medical Center

    Portland, Oregon, 97213-2967

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • Knight Cancer Institute at Oregon Health and Science University

    Portland, Oregon, 97239-3098

  • CCOP - Kansas City

    Prairie Village, Kansas, 66208

  • Utah Valley Regional Medical Center - Provo

    Provo, Utah, 84604

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

  • McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

    Reading, Pennsylvania, 19612-6052

  • Renown Institute for Cancer at Renown Regional Medical Center

    Reno, Nevada, 89502

  • Highland Hospital of Rochester

    Rochester, New York, 14620

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, 14642

  • Rohnert Park Cancer Center

    Rohnert Park, California, 94928

  • Radiation Oncology Center - Roseville

    Roseville, California, 95661

  • Radiological Associates of Sacramento Medical Group, Incorporated

    Sacramento, California, 95815

  • Mercy General Hospital

    Sacramento, California, 95819

  • Flagler Cancer Center

    Saint Augustine, Florida, 32086

  • Park Nicollet Cancer Center

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital Cancer Care Center

    Saint Paul, Minnesota, 55101

  • Utah Cancer Specialists at UCS Cancer Center

    Salt Lake City, Utah, 84106

  • Huntsman Cancer Institute at University of Utah

    Salt Lake City, Utah, 84112

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94115

  • Study site

    Santa Clara, California, 95051

  • Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

    Savannah, Georgia, 31403-3089

  • Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler

    Savannah, Georgia, 31405

  • Maine Center for Cancer Medicine and Blood Disorders - Scarborough

    Scarborough, Maine, 04074

  • CCOP - Virginia Mason Research Center

    Seattle, Washington, 98101

  • Siouxland Hematology-Oncology Associates, LLP

    Sioux City, Iowa, 51101

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Kaiser Permanente Medical Center - South San Francisco

    South San Francisco, California, 94080

  • Frederick R. and Betty M. Smith Cancer Treatment Center

    Sparta, New Jersey, 07871

  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Cancer Centers of the Carolinas - Spartanburg

    Spartanburg, South Carolina, 29307

  • Cancer Institute at St. John's Hospital

    Springfield, Illinois, 62702

  • Regional Cancer Center at Memorial Medical Center

    Springfield, Illinois, 62781-0001

  • Hulston Cancer Center at Cox Medical Center South

    Springfield, Missouri, 65807

  • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

    St Louis, Missouri, 63110

  • Barnes-Jewish West County Hospital

    St Louis, Missouri, 63141

  • CCOP - St. Louis-Cape Girardeau

    St Louis, Missouri, 63141

  • David C. Pratt Cancer Center at St. John's Mercy

    St Louis, Missouri, 63141

  • Flower Hospital Cancer Center

    Sylvania, Ohio, 43560

  • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

    Tampa, Florida, 33612-9497

  • North Suburban Medical Center

    Thornton, Colorado, 80229

  • St. Anne Mercy Hospital

    Toledo, Ohio, 43623

  • Natalie Warren Bryant Cancer Center at St. Francis Hospital

    Tulsa, Oklahoma, 74136

  • Solano Radiation Oncology Center

    Vacaville, California, 95687

  • Northwest Cancer Specialists at Vancouver Cancer Center

    Vancouver, Washington, 98684

  • Coastal Cancer Center at Sentara Virginia Beach General Hospital

    Virginia Beach, Virginia, 23454

  • Cancer Institute of New Jersey at Cooper - Voorhees

    Voorhees Township, New Jersey, 08043

  • University of Wisconcin Cancer Center at Aspirus Wausau Hospital

    Wausau, Wisconsin, 54401

  • Precision Radiotherapy at University Pointe

    West Chester, Ohio, 45069

  • UHHS Westlake Medical Center

    Westlake, Ohio, 44145

  • Schiffler Cancer Center at Wheeling Hospital

    Wheeling, West Virginia, 26003

  • Cancer Treatment Center

    Wooster, Ohio, 44691

  • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital

    Yakima, Washington, 98902

  • York Cancer Center at Apple Hill Medical Center

    York, Pennsylvania, 17405

Other trials in United States

Canada2 sites

  • McGill Cancer Centre at McGill University

    Montreal, Quebec, H2W 1S6

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

About this study

Official title: Phase III Trial of Radiotherapy Plus Cetuximab Versus Chemoradiotherapy in HPV-Associated Oropharynx Cancer

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.

Read the 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 (1 year).
  • 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 human papilloma virus (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.

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.

Being tested
cetuximab, cisplatin, IMRT
Keywords
stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, human papilloma virus infection
Medical subject headings
Head and Neck Neoplasms, Precancerous Conditions, Squamous Cell Carcinoma of Head and Neck, Papillomavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cetuximabBiological

    400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks

  • cisplatinDrug

    100 mg/m2 IV on days 1 and 22 of IMRT

  • IMRTRadiation

    Also called intensity-modulated radiotherapy, intensity-modulated radiation therapy

    35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.

Study groups in NCT01302834
Study groupRoleWhat they receive
IMRT + CisplatinActive comparatorIntensity-modulated radiotherapy (IMRT) with concurrent cisplatin
Receives: Drug: cisplatin; Radiation: IMRT
IMRT + CetuximabActive comparatorIntensity-modulated radiotherapy (IMRT) with concurrent cetuximab
Receives: Biological: cetuximab; Radiation: IMRT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    An event for overall survival is death due to any cause. Survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is hazard ratio, which is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.

    Measured: From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.

Secondary outcomes (44)

  1. Progression-free Survival

    An event for progression-free survival is local, regional, or distant disease progression or death due to any cause. Progression-free survival time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is the distribution of progression-free survival times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.

    Measured: From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.

  2. Time to Local-regional Failure

    Failure for local-regional failure endpoint was defined as local or regional progression, salvage surgery of the primary tumor with tumor present/unknown, salvage neck dissection with tumor present/unknown > 20 weeks after the end of radiation therapy, death due to study cancer without documented progression, or death due to unknown causes without documented progression; distant metastasis and death due to other causes were considered competing risks. Local-regional failure time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the cumulative incidence method. The protocol endpoint is the distribution of local-regional failure times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.

    Measured: From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.

  3. Time to Distant Metastasis

    Failure for distant metastasis endpoint was defined as distant progression; local-regional failure and death due to any cause were considered competing risks. Distant metastasis time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the cumulative incidence method. The protocol endpoint is the distribution of distant metastasis times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.

    Measured: From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.

  4. Time to Secondary Primary Cancer

    Failure for second primary endpoint was defined as reporting of a new primary cancer; death due to any cause was considered a competing risk. Second primary time is defined as time from randomization to the date of second primary or last known follow-up (censored). Rates are estimated by the cumulative incidence method. The protocol endpoint is the distribution of second primary cancer times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.

    Measured: From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.

  5. Distribution of First Progression Events

    The first event type for progression-free survival is counted for each participant. Possible first progression events are local, regional, or distant progression, any combination of these, or death. The frequency table of these events is also referred to as "Pattern of failure."

    Measured: From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.

  6. Percentage of Participants Experiencing Early Death

    Early death is defined as death due to adverse event or within 30 days of treatment completion.

    Measured: From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.

  7. Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: During Treatment

    Acute adverse events (AE) are defined as occurring within 180 days from the end of treatment. "Treatment-related" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE

    Measured: From start of treatment to end of treatment, approximately 6 weeks

  8. Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: 1 Month After End of Study Treatment

    Acute adverse events (AE) are defined as occurring within 180 days from the end of treatment. "Treatment-related" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE

    Measured: From start of treatment to approximately 2.5 months (1 month after the end of treatment)

  9. Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: 3 Months After the End of Study Treatment

    Acute adverse events (AE) are defined as occurring within 180 days from the end of treatment. "Treatment-related" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE

    Measured: From start of treatment to approximately 4.5 months (3 months after the end of treatment)

  10. Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: 6 Months After the End of Study Treatment

    Acute adverse events (AE) are defined as occurring within 180 days from the end of treatment. "Treatment-related" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE

    Measured: From start of treatment to approximately 7.5 months (6 months after the end of treatment)

  11. Percentage of Participants With Late Grade 3-4 Treatment-related Adverse Events: 1 Year After the End of Study Treatment

    Late adverse events (AE) are defined as > 180 days from end of treatment. "Treatment-related" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE

    Measured: From start of treatment to approximately 13.5 months (one year after the end of treatment)

  12. Percentage of Participants With Late Grade 3-4 Treatment-related Adverse Events: 2 Years After the End of Study Treatment

    Late adverse events (AE) are defined as > 180 days from end of treatment. "Treatment-related" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE

    Measured: From 180 days after end of treatment to two years after end of treatment.

  13. Percentage of Participants With Late Grade 3-4 Treatment-related Adverse Events: 5 Years After the End of Study Treatment

    Late adverse events (AE) are defined as > 180 days from end of treatment. "Treatment-related" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE

    Measured: From start of treatment to approximately 61.5 months (five years after the end of treatment)

  14. Percentage of Participants With a Feeding Tube at 1 Year

    Measured: From randomization to 1 year.

  15. EORTC QLQ-C30 Global Health Status Score Change From Baseline at End of Treatment

    The EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30) Global Health Status score measures a cancer patient's perception of their overall health and well-being and ranges from 0 (worst) to 100 (best). A positive change from baseline indicates improvement.

    Measured: Baseline and end of treatment (6-7 weeks)

  16. EORTC QLQ-C30 Global Health Status Score Change From Baseline at 3 Months From End of Treatment

    The EORTC QLQ-C30 Global Health Status score measures a cancer patient's perception of their overall health and well-being and ranges from 0 (worst) to 100 (best). A positive change from baseline indicates improvement.

    Measured: Baseline and 3 months from end of treatment. Treatment lasts 6-7 weeks.

  17. EORTC QLQ-C30 Global Health Status Score Change From Baseline at 6 Months From End of Treatment

    The EORTC QLQ-C30 Global Health Status score measures a cancer patient's perception of their overall health and well-being and ranges from 0 (worst) to 100 (best). A positive change from baseline indicates improvement.

    Measured: Baseline and 6 months from end of treatment. Treatment lasts 6-7 weeks.

  18. EORTC QLQ-C30 Global Health Status Score Change From Baseline at 12 Months From End of Treatment

    The EORTC QLQ-C30 Global Health Status score measures a cancer patient's perception of their overall health and well-being and ranges from 0 (worst) to 100 (best). A positive change from baseline indicates improvement.

    Measured: Baseline and 12 months from end of treatment. Treatment lasts 6-7 weeks

  19. EORTC QLQ-H&N35 Swallowing Score Change From Baseline at End of Treatment

    The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Head and Neck Cancer Module (EORTC QLQ-H\&N35) swallowing score measures patient-reported difficulty with swallowing various foods and liquid and ranges from 0 (no swallowing problems) to 100 (maximum swallowing difficulty). A positive change from baseline indicates worsening swallowing function.

    Measured: Baseline and end of treatment (6-7 weeks)

  20. EORTC QLQ-H&N35 Swallowing Score Change From Baseline at 3 Months From End of Treatment.

    The EORTC QLQ-H\&N35 swallowing score measures patient-reported difficulty with swallowing various foods and liquid and ranges from 0 (no swallowing problems) to 100 (maximum swallowing difficulty). A positive change from baseline indicates worsening swallowing function.

    Measured: Baseline and 3 months from end of treatment. Treatment lasts 6-7 weeks.

  21. EORTC QLQ-H&N35 Swallowing Score Change From Baseline at 6 Months From End of Treatment.

    The EORTC QLQ-H\&N35 swallowing score measures patient-reported difficulty with swallowing various foods and liquid and ranges from 0 (no swallowing problems) to 100 (maximum swallowing difficulty). A positive change from baseline indicates worsening swallowing function.

    Measured: Baseline and 6 months from end of treatment. Treatment lasts 6-7 weeks.

  22. EORTC QLQ-H&N35 Swallowing Score Change From Baseline at 12 Months From End of Treatment.

    The EORTC QLQ-H\&N35 swallowing score measures patient-reported difficulty with swallowing various foods and liquid and ranges from 0 (no swallowing problems) to 100 (maximum swallowing difficulty). A positive change from baseline indicates worsening swallowing function.

    Measured: Baseline and 12 months from end of treatment. Treatment lasts 6-7 weeks.

  23. Number of Participants With Post-baseline Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events for Head and Neck (PRO-CTCAE H&N) Scores >= 3

    PRO-CTCAE is a patient-reported outcome (PRO) measurement system developed to evaluate symptomatic toxicity in patients on cancer clinical trials, asking the patient about experience over the last seven days. Scores may reflect worst severity of the symptom (0=None, 1=Mild, 2=Moderate, 3=Severe, and 4=Very severe), frequency of the symptom (0=Never, 1=Rarely, 2=Occasionally, 3=Frequently, 4=Almost constantly), or the symptom's interference with one's "usual or daily activities" (0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much). The symptom row title will indicate "Severity", "Frequency", or "Interference". All scores are compared between arms; statistical analysis results are entered for p-values < 0.05.

    Measured: End of treatment (approximately 6 weeks after baseline); and 3, 6, and 12 months after end of treatment (approximately 4.5, 7.5, and 13.5 months after baseline).

  24. EuroQol Five Dimension Scale 3-level Version (EQ-5D-3L) Index Score Change From Baseline

    The EQ-5D-3L index score measures health-related quality of life using five items (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with three levels of severity (1 = no problems, 2 = moderate problems, 3 = extreme problems). Responses across the five items are combined and transformed into a single utility (index) score. Possible scores range from 0 to 1, with higher scores indicating a better outcome. The change score was calculated as the postbaseline value minus the baseline value. A negative change reflects decline at the postbaseline timepoint and a positive change reflects improvement at the postbaseline timepoint.

    Measured: Basline, end of treatment (6-7 weeks), and 3, 6, and 12 months from end of treatment.

  25. EuroQol Five Dimension Scale 3-level Version (EQ-5D-3L) Visual Analogue Scale (VAS) Change From Baseline

    The EQ-5D-3L VAS measures a patient's self-rated current health state using a visual analogue scale measured on a 20-cm scale with 10-point intervals. Scores range from 0 at the bottom of the scale, representing the worst imaginable health state, to 100 at the top of the scale, representing the best imaginable health state. The change score was calculated as the postbaseline value minus the baseline value. A negative change reflects decline at the postbaseline timepoint and a positive change reflects improvement at the postbaseline timepoint.

    Measured: Basline, end of treatment (6-7 weeks), and 3, 6, and 12 months from end of treatment.

  26. Number of Participants by Work Status Category at Baseline

    Participants selected all current work status categories that applied. Therefore, category counts are not mutually exclusive and may sum to more than the number of participants analyzed.

    Measured: Baseline

  27. Number of Participants by Work Status Category at End of Treatment

    Participants selected all current work status categories that applied. Therefore, category counts are not mutually exclusive and may sum to more than the number of participants analyzed.

    Measured: End of treatment (6-7 weeks)

  28. Number of Participants by Work Status Category at 3 Months After End of Treatment

    Participants selected all current work status categories that applied. Therefore, category counts are not mutually exclusive and may sum to more than the number of participants analyzed.

    Measured: Three months after end of treatment (6-7 weeks).

  29. Number of Participants by Work Status Category at 6 Months After End of Treatment

    Participants selected all current work status categories that applied. Therefore, category counts are not mutually exclusive and may sum to more than the number of participants analyzed.

    Measured: Six months after end of treatment (6-7 weeks).

  30. Number of Participants by Work Status Category at 12 Months After End of Treatment

    Participants selected all current work status categories that applied. Therefore, category counts are not mutually exclusive and may sum to more than the number of participants analyzed.

    Measured: Twelve months after end of treatment (6-7 weeks).

  31. Percentage of Patients With Normal/Good Dental Health: Pretreatment

    This study utilized a dental effects health scale from 0 (normal) to 4 (life-threatening dental condition). The percentage of participants with a value of 0 or 1 is reported: 0 = "Normal: Edentulous, with no gingival disease";

    1 = "Mild changes/good dental health: mild periodontal inflammation-routine cleaning indicated; < 5 restorations indicated; no extractions indicated." Ten year data is not yet available.

    Measured: Before treatment

  32. Percentage of Patients With Normal/Good Dental Health: 1 Year After End of Treatment

    This study utilized a dental effects health scale from 0 (normal) to 4 (life-threatening dental condition). The percentage of participants with a value of 0 or 1 is reported: 0 = "Normal: Edentulous, with no gingival disease";

    1 = "Mild changes/good dental health: mild periodontal inflammation-routine cleaning indicated; < 5 restorations indicated; no extractions indicated."

    Measured: 1 year after end of treatment (approximately 13.5 months)

  33. Percentage of Patients With Normal/Good Dental Health: 2 Years After End of Treatment

    This study utilized a dental effects health scale from 0 (normal) to 4 (life-threatening dental condition). The percentage of participants with a value of 0 or 1 is reported: 0 = "Normal: Edentulous, with no gingival disease"; 1 = "Mild changes/good dental health: mild periodontal inflammation-routine cleaning indicated; < 5 restorations indicated; no extractions indicated."

    Measured: 2 years after end of treatment (approximately 25.5 months)

  34. Percentage of Patients With Normal/Good Dental Health: 5 Years After End of Treatment

    This study utilized a dental effects health scale from 0 (normal) to 4 (life-threatening dental condition). The percentage of participants with a value of 0 or 1 is reported: 0 = "Normal: Edentulous, with no gingival disease"; 1 = "Mild changes/good dental health: mild periodontal inflammation-routine cleaning indicated; < 5 restorations indicated; no extractions indicated."

    Measured: 5 years after end of treatment (approximately 61.5 months)

  35. Percentage of Patients With Normal/Good Dental Health: 10 Years After End of Treatment

    This study utilized a dental effects health scale from 0 (normal) to 4 (life-threatening dental condition). The percentage of participants with a value of 0 or 1 is reported: 0 = "Normal: Edentulous, with no gingival disease"; 1 = "Mild changes/good dental health: mild periodontal inflammation-routine cleaning indicated; < 5 restorations indicated; no extractions indicated."

    Measured: 10 years after end of treatment (approximately 121.5 months)

  36. Number of Participants by HHIA-S Category at Baseline

    The Hearing Handicap Inventory for Adults Screen Version (HHIA-S) measures a person's perceived hearing handicap. Total score ranges from 0 to 40, with a higher score indicating more severe perceived hearing handicap, categorized as follows:

    • No handicap: 0-8.
    • Mild-moderate handicap: 10-24.
    • Severe handicap: 26-40.

    Measured: Baseline

  37. Number of Participants by HHIA-S Category at End of Treatment

    The Hearing Handicap Inventory for Adults Screen Version (HHIA-S) measures a person's perceived hearing handicap. Total score ranges from 0 to 40, with a higher score indicating more severe perceived hearing handicap, categorized as follows:

    • No handicap: 0-8.
    • Mild-moderate handicap: 10-24.
    • Severe handicap: 26-40.

    Measured: End of treatment (6-7 weeks)

  38. Number of Participants by HHIA-S Category at 3 Months After End of Treatment

    The HHIA-S measures a person's perceived hearing handicap. Total score ranges from 0 to 40, with a higher score indicating more severe perceived hearing handicap, categorized as follows:

    • No handicap: 0-8.
    • Mild-moderate handicap: 10-24.
    • Severe handicap: 26-40.

    Measured: 3 months after end of treatment. Treatment lasts 6-7 weeks.

  39. Number of Participants by HHIA-S Category at 6 Months After End of Treatment

    The HHIA-S measures a person's perceived hearing handicap. Total score ranges from 0 to 40, with a higher score indicating more severe perceived hearing handicap, categorized as follows:

    • No handicap: 0-8.
    • Mild-moderate handicap: 10-24.
    • Severe handicap: 26-40.

    Measured: 6 months after end of treatment. Treatment lasts 6-7 weeks.

  40. Number of Participants by HHIA-S Category at 12 Months After End of Treatment

    The HHIA-S measures a person's perceived hearing handicap. Total score ranges from 0 to 40, with a higher score indicating more severe perceived hearing handicap, categorized as follows:

    • No handicap: 0-8.
    • Mild-moderate handicap: 10-24.
    • Severe handicap: 26-40.

    Measured: 12 months after end of treatment. Treatment lasts 6-7 weeks.

  41. Overall Survival by KRAS (Kirsten Rat Sarcoma Viral Oncogene Homolog) Variant Status

    KRAS (Kirsten Rat Sarcoma Viral Oncogene Homolog) is a gene that helps control how cells grow. Some people have a change in this gene, which can be detected (variant/non-variant) by a genetic test performed on tissue from their tumor. Research suggests that this change may influence how head and neck cancer responds to certain treatments.

    An event for overall survival is death due to any cause. Survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is hazard ratio, which is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.

    Measured: From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 214 deaths were reported. Median follow-up at time of analysis was 8.3 years.

  42. Progression-free Survival by KRAS Variant Status

    KRAS (Kirsten Rat Sarcoma Viral Oncogene Homolog) is a gene that helps control how cells grow. Some people have a change in this gene, which can be detected (variant/non-variant) by a genetic test performed on tissue from their tumor. Research suggests that this change may influence how head and neck cancer responds to certain treatments.

    An event for progression-free survival is local, regional, or distant disease progression or death due to any cause. Progression-free survival time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is the distribution of progression-free survival times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.

    Measured: From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 214 deaths were reported. Median follow-up at time of analysis was 8.3 years.

  43. Overall Survival by Treatment Arm Within KRAS Variant Status Group

    KRAS (Kirsten Rat Sarcoma Viral Oncogene Homolog) is a gene that helps control how cells grow. Some people have a change in this gene, which can be detected (variant/non-variant) by a genetic test performed on tissue from their tumor. Research suggests that this change may influence how head and neck cancer responds to certain treatments.

    An event for overall survival is death due to any cause. Survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is hazard ratio, which is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.

    Measured: From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 214 deaths were reported. Median follow-up at time of analysis was 8.3 years.

  44. Progression-free Survival Within KRAS Variant Status

    KRAS (Kirsten Rat Sarcoma Viral Oncogene Homolog) is a gene that helps control how cells grow. Some people have a change in this gene, which can be detected (variant/non-variant) by a genetic test performed on tissue from their tumor. Research suggests that this change may influence how head and neck cancer responds to certain treatments.

    An event for progression-free survival is local, regional, or distant disease progression or death due to any cause. Progression-free survival time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is the distribution of progression-free survival times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.

    Measured: From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 214 deaths were reported. Median follow-up at time of analysis was 8.3 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2011 (estimated)
  2. Study startJun 2011
  3. Primary completion12 Jul 2018
  4. Study completion4 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
987 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01302834
Sponsor's protocol ID
RTOG-1016
Other IDs
CDR0000695731, NCI-2011-02638
Status last verified
Sep 2025
First submitted
22 Feb 2011
Last updated
20 Jul 2026
Data monitoring committee
Yes

Publications

  • Gillison ML, Trotti AM, Harris J, Eisbruch A, Harari PM, Adelstein DJ, Jordan RCK, Zhao W, Sturgis EM, Burtness B, Ridge JA, Ringash J, Galvin J, Yao M, Koyfman SA, Blakaj DM, Razaq MA, Colevas AD, Beitler JJ, Jones CU, Dunlap NE, Seaward SA, Spencer S, Galloway TJ, Phan J, Dignam JJ, Le QT. Radiotherapy plus cetuximab or cisplatin in human papillomavirus-positive oropharyngeal cancer (NRG Oncology RTOG 1016): a randomised, multicentre, non-inferiority trial. Lancet. 2019 Jan 5;393(10166):40-50. doi: 10.1016/S0140-6736(18)32779-X. Epub 2018 Nov 15.

    PubMed 30449625

  • Fleming CW, Reddy CA, Stock S, Lee J, Gillison M, Caudell JJ, Geiger JL, Blakaj DM, Krempl GA, Colevas AD, Jones CU, Saba NF, Phan J, Galloway TJ, Seaward S, Spencer S, Torres-Saavedra P, Yom SS, Le QT, Koyfman SA. Imaging-Detected Extranodal Extension in p16-Positive Oropharyngeal Cancer: Secondary Analysis of RTOG 1016. JAMA Otolaryngol Head Neck Surg. 2026 Aug 27:10.1001/jamaoto.2026.0932. doi: 10.1001/jamaoto.2026.0932. Online ahead of print.

    PubMed 42658511

  • Gharzai LA, Morris E, Schipper MJ, Kidwell KM, Nguyen-Tan PF, Rosenthal DI, Gillison ML, Jordan RC, Garden AS, Koyfman SA, Caudell JJ, Blakaj DM, Dunlap NE, Krempl GA, Longo JM, Jones CU, Gensheimer MF, Galloway TJ, DeMora L, Le QT, Shah JL, Suresh K, Mierzwa M. Treatment Interruption and Outcomes in Head and Neck Cancer: A Secondary Analysis of 3 Randomized Clinical Trials. JAMA Otolaryngol Head Neck Surg. 2026 Feb 1;152(2):144-153. doi: 10.1001/jamaoto.2025.4203.

    PubMed 41343184

  • Quan DL, Grauer JS, Sunkara PR, Cramer JD. Surgical salvage of human papillomavirus-positive oropharyngeal cancer: Secondary analysis of a randomized controlled trial. Cancer. 2023 Feb 1;129(3):376-384. doi: 10.1002/cncr.34562. Epub 2022 Nov 19.

    PubMed 36401615

  • Psyrri A, Rampias T, Vermorken JB. The current and future impact of human papillomavirus on treatment of squamous cell carcinoma of the head and neck. Ann Oncol. 2014 Nov;25(11):2101-2115. doi: 10.1093/annonc/mdu265. Epub 2014 Jul 23.

    PubMed 25057165

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cetuximab, cisplatin and IMRT in people with Head and Neck Cancer and Precancerous Condition, run by Radiation Therapy Oncology Group at 185 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 185 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01302834, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.

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