Radiation Therapy With Cisplatin or Cetuximab in Treating Patients With Oropharyngeal Cancer
NCT ID: NCT01302834
Last Updated: 2026-01-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
987 participants
INTERVENTIONAL
2011-06-30
2025-09-04
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IMRT + Cisplatin
Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin
cisplatin
100 mg/m2 IV on days 1 and 22 of IMRT
IMRT
35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
IMRT + Cetuximab
Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab
cetuximab
400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks
IMRT
35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Interventions
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cetuximab
400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks
cisplatin
100 mg/m2 IV on days 1 and 22 of IMRT
IMRT
35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients must be positive for p16, determined by central review prior to randomization.
3. 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.
4. 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;
* One of the following combinations of imaging is required within 8 weeks prior to registration:
1. A computerized tomography (CT) scan of the neck (with contrast) and a chest CT scan (with or without contrast);
2. or a magnetic resonance imaging (MRI) scan of the neck (with contrast) and a chest CT scan (with or without contrast);
3. or a CT scan of neck (with contrast) and a positron emission tomography (PET)/CT of neck and chest (with or without contrast);
4. 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.
5. Zubrod Performance Status 0-1 within 2 weeks prior to registration
6. Age ≥ 18;
7. 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.
8. 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;
9. 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)
10. Patients must provide their smoking history (for stratification) via the computer-assisted self interview (CASI) head and neck risk factor survey tool.
11. Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential;
12. 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.
13. 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.
14. 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.
Exclusion Criteria
2. Stage T1-2, N0-1;
3. Distant metastasis or adenopathy below the clavicles;
4. 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.
5. Simultaneous primaries or bilateral tumors;
6. 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);
7. Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable;
8. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
9. 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.
10. 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.
11. Prior allergic reaction to cisplatin or cetuximab;
12. Prior cetuximab or other anti-EGFR therapy.
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
NRG Oncology
OTHER
Radiation Therapy Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Andy M. Trotti, MD
Role: PRINCIPAL_INVESTIGATOR
H. Lee Moffitt Cancer Center and Research Institute
Maura Gillison, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Locations
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Providence Cancer Center
Anchorage, Alaska, United States
Auburn Radiation Oncology
Auburn, California, United States
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
Burbank, California, United States
Radiation Oncology Centers - Cameron Park
Cameron Park, California, United States
Mercy Cancer Center at Mercy San Juan Medical Center
Carmichael, California, United States
Enloe Cancer Center at Enloe Medical Center
Chico, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States
Kaiser Permanente - Division of Research - Oakland
Oakland, California, United States
Rohnert Park Cancer Center
Rohnert Park, California, United States
Radiation Oncology Center - Roseville
Roseville, California, United States
Radiological Associates of Sacramento Medical Group, Incorporated
Sacramento, California, United States
Mercy General Hospital
Sacramento, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Santa Clara, California, United States
Kaiser Permanente Medical Center - South San Francisco
South San Francisco, California, United States
Solano Radiation Oncology Center
Vacaville, California, United States
Rocky Mountain Cancer Centers - Aurora
Aurora, Colorado, United States
Boulder Community Hospital
Boulder, Colorado, United States
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States
Porter Adventist Hospital
Denver, Colorado, United States
Swedish Medical Center
Englewood, Colorado, United States
McKee Medical Center
Loveland, Colorado, United States
North Suburban Medical Center
Thornton, Colorado, United States
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
New Britain, Connecticut, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
North Broward Medical Center
Deerfield Beach, Florida, United States
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, United States
Integrated Community Oncology Network at Southside Cancer Center
Jacksonville, Florida, United States
Baptist Medical Center South
Jacksonville, Florida, United States
Integrated Community Oncology Network
Jacksonville Beach, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States
Integrated Community Oncology Network - Orange Park
Orange Park, Florida, United States
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando, Florida, United States
M.D. Anderson Cancer Center at Orlando
Orlando, Florida, United States
Florida Cancer Center - Palatka
Palatka, Florida, United States
Sacred Heart Cancer Center at Sacred Heart Hospital
Pensacola, Florida, United States
Flagler Cancer Center
Saint Augustine, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States
Georgia Cancer Center for Excellence at Grady Memorial Hospital
Atlanta, Georgia, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
Savannah, Georgia, United States
Northwest Community Hospital
Arlington Heights, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Creticos Cancer Center at Advocate Illinois Masonic Medical Center
Chicago, Illinois, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States
Evanston Hospital
Evanston, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States
Cancer Institute at St. John's Hospital
Springfield, Illinois, United States
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States
Elkhart General Hospital
Elkhart, Indiana, United States
Parkview Regional Cancer Center at Parkview Health
Fort Wayne, Indiana, United States
Center for Cancer Care at Goshen General Hospital
Goshen, Indiana, United States
Community Regional Cancer Care at Community Hospital East
Indianapolis, Indiana, United States
Community Regional Cancer Care at Community Hospital North
Indianapolis, Indiana, United States
Michiana Hematology-Oncology, PC - South Bend
Mishawaka, Indiana, United States
Cancer Center at Ball Memorial Hospital
Muncie, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
McFarland Clinic, PC
Ames, Iowa, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States
Kansas City Cancer Centers - Southwest
Overland Park, Kansas, United States
CCOP - Kansas City
Prairie Village, Kansas, United States
Lucille P. Markey Cancer Center at University of Kentucky
Lexington, Kentucky, United States
James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge, Louisiana, United States
CCOP - Ochsner
New Orleans, Louisiana, United States
Maine Center for Cancer Medicine and Blood Disorders - Scarborough
Scarborough, Maine, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States
St. Agnes Hospital Cancer Center
Baltimore, Maryland, United States
Lahey Clinic Medical Center - Burlington
Burlington, Massachusetts, United States
NSMC Cancer Center - Peabody
Danvers, Massachusetts, United States
Hudner Oncology Center at Saint Anne's Hospital - Fall River
Fall River, Massachusetts, United States
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, United States
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan, United States
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States
Fairview Southdale Hospital
Edina, Minnesota, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, United States
Regions Hospital Cancer Care Center
Saint Paul, Minnesota, United States
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, United States
Cancer Institute of Cape Girardeau, LLC
Cape Girardeau, Missouri, United States
Kansas City Cancer Centers - South
Kansas City, Missouri, United States
Kansas City Cancer Centers - North
Kansas City, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, United States
Barnes-Jewish West County Hospital
St Louis, Missouri, United States
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, United States
David C. Pratt Cancer Center at St. John's Mercy
St Louis, Missouri, United States
Billings Clinic - Downtown
Billings, Montana, United States
Methodist Estabrook Cancer Center
Omaha, Nebraska, United States
Nebraska Medical Center
Omaha, Nebraska, United States
Renown Institute for Cancer at Renown Regional Medical Center
Reno, Nevada, United States
Payson Center for Cancer Care at Concord Hospital
Concord, New Hampshire, United States
Seacoast Cancer Center at Wentworth - Douglass Hospital
Dover, New Hampshire, United States
Kingsbury Center for Cancer Care at Cheshire Medical Center
Keene, New Hampshire, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Monmouth Medical Center
Long Branch, New Jersey, United States
Frederick R. and Betty M. Smith Cancer Treatment Center
Sparta, New Jersey, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Lourdes Regional Cancer Center
Binghamton, New York, United States
Highland Hospital of Rochester
Rochester, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
Greensboro, North Carolina, United States
Kinston Medical Specialists
Kinston, North Carolina, United States
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
Pinehurst, North Carolina, United States
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, United States
Barberton Citizens Hospital
Barberton, Ohio, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States
Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Northwest Ohio Oncology Center
Maumee, Ohio, United States
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, United States
Lake/University Ireland Cancer Center
Mentor, Ohio, United States
Southwest General Health Center
Middleburg Heights, Ohio, United States
St. Charles Mercy Hospital
Oregon, Ohio, United States
Flower Hospital Cancer Center
Sylvania, Ohio, United States
St. Anne Mercy Hospital
Toledo, Ohio, United States
Precision Radiotherapy at University Pointe
West Chester, Ohio, United States
UHHS Westlake Medical Center
Westlake, Ohio, United States
Cancer Treatment Center
Wooster, Ohio, United States
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States
Dubs Cancer Center at Rogue Valley Medical Center
Medford, Oregon, United States
Providence Cancer Center at PMCC
Medford, Oregon, United States
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Knight Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, United States
Dale and Frances Hughes Cancer Center at Pocono Medical Center
East Stroudsburg, Pennsylvania, United States
Adams Cancer Center
Gettysburg, Pennsylvania, United States
Cherry Tree Cancer Center
Hanover, Pennsylvania, United States
St. Mary Regional Cancer Center
Langhorne, Pennsylvania, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading, Pennsylvania, United States
York Cancer Center at Apple Hill Medical Center
York, Pennsylvania, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States
Cancer Centers of the Carolinas - Faris Road
Greenville, South Carolina, United States
CCOP - Greenville
Greenville, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Cancer Centers of the Carolinas - Spartanburg
Spartanburg, South Carolina, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
University of Texas Medical Branch
Galveston, Texas, United States
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Murray, Utah, United States
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
Ogden, Utah, United States
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, United States
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States
Sentara Cancer Institute at Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Coastal Cancer Center at Sentara Virginia Beach General Hospital
Virginia Beach, Virginia, United States
St. Joseph Cancer Center
Bellingham, Washington, United States
CCOP - Virginia Mason Research Center
Seattle, Washington, United States
Northwest Cancer Specialists at Vancouver Cancer Center
Vancouver, Washington, United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, United States
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
Huntington, West Virginia, United States
Schiffler Cancer Center at Wheeling Hospital
Wheeling, West Virginia, United States
Theda Care Cancer Institute
Appleton, Wisconsin, United States
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee
Milwaukee, Wisconsin, United States
University of Wisconcin Cancer Center at Aspirus Wausau Hospital
Wausau, Wisconsin, United States
CancerCare Manitoba
Winnipeg, Manitoba, Canada
McGill Cancer Centre at McGill University
Montreal, Quebec, Canada
Countries
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References
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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.
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. 2025 Dec 4:e254203. doi: 10.1001/jamaoto.2025.4203. Online ahead of print.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Study Documents
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Document Type: Individual Participant Data Set
Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive
View DocumentOther Identifiers
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CDR0000695731
Identifier Type: -
Identifier Source: secondary_id
NCI-2011-02638
Identifier Type: REGISTRY
Identifier Source: secondary_id
RTOG-1016
Identifier Type: -
Identifier Source: org_study_id
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