Can less radiation after throat surgery be just as effective?
NCT ID NCT01898494
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at people with HPV-positive throat cancer that has spread but can still be removed with surgery. After surgery, some patients get the usual high-dose radiation plus chemo, while others get a lower dose. The goal is to see if the lower dose works just as well and causes fewer side effects. About 519 adults with stage III-IVB cancer took part.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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519 people
The number who actually took part.
- Started
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Jan 2014
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Registration to Surgery (Arm S) * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Patients must have newly diagnosed, histologically or cytologically confirmed squamous cell carcinoma or undifferentiated carcinoma of the oropharynx; patients must have been determined to have resectable oropharyngeal disease; patients with primary tumor or nodal metastasis fixed to the carotid artery, skull base or cervical spine are not eligible * Patients must have American Joint Committee on Cancer (AJCC) TNM tumor stage III, IV a, or IV b (with no evidence of distant metastases) as determined by imaging studies (performed \< 30 days prior to pre-registration) and complete head and neck exam; the following imaging is required: computed tomography (CT) scan with IV contrast or magnetic resonance imaging (MRI) * Patients must have biopsy-proven p16+ oropharynx cancer; the histologic evidence of invasive squamous cell carcinoma may have been obtained from the primary tumor or metastatic lymph node. It is required that patients have a positive p16 IHC (as surrogate for HPV) status from either the primary tumor or metastatic lymph node. * Carcinoma of the oropharynx associated with HPV as determined by p16 protein expression using immunohistochemistry (IHC) performed by a Clinical Laboratory Improvement Amendments (CLIA) approved laboratory; using p16 antibody obtained from Roche mtm laboratories AG (CINtec, clone E6H4) is recommended * Patients with a history of a curatively treated malignancy must be disease-free for at least two years except for carcinoma in situ of cervix and/or non-melanomatous skin cancer * Patients with the following within the last 6 months prior to pre-registration must be evaluated by a cardiologist and/or neurologist prior to entry into the study * Congestive heart failure \> NYHA Class II * Cerebrovascular accident (CVA)/transient ischaemic attack (TIA) * Unstable angina * Myocardial infarction * Absolute neutrophil count \>= 1,500/mm\^3 * Platelets \>= 100,000/mm\^3 * Total bilirubin =\< the upper limit of normal (ULN) * Calculated creatinine clearance must be \> 60 ml/min using the Cockcroft-Gault formula Registration/Randomization to Step2 - Arms A, B, C and D * Histopathologic assessment of surgical pathology must include examination for perineural invasion (PNI) and lymphovascular invasion (LVI) and reported as absent or present; the absence or presence of extracapsular extension (ECE) requires gross and microscopic assessment and is defined to be: * Absent (negative or nodal metastasis with smooth/rounded leading edge confined to thickened capsule/pseudocapsule), * Present - minimal (tumor extends =\< 1 mm beyond the lymph node capsule), or * Present - extensive (gross, tumor extends \> 1 mm beyond the lymph node capsule (includes soft tissue metastasis) * Patient must be stratified/classified into one of the following risk categories (the highest risk feature assessed pathologically will determine the patient's category/treatment arm assignment): * Low Risk: T1-T2, N0-N1 AND clear (≥ 3mm) margins, AND no ECE or PNI/LVI * High Risk: Any of the following features: one or more positive margin(s) with any T stage, OR "Extensive" (\> 1mm) ECE, OR ≥ 5 metastatic lymph nodes (regardless of primary tumor margin status) * Intermediate Risk: Any of the following features: one or more "close" (\< 3mm) margin(s), OR "Minimal" (≤ 1mm) ECE, OR N2a (1 or more lymph node \> 3cm in diameter), OR N2b (2-4 lymph nodes positive, any diameter ≤ 6cm), OR with perineural invasion or lymphovascular invasion. * Unknown Risk: Patients found to have N2C or N3 disease on final pathologic analysis are at unknown risk for recurrence, but are not candidates for deintensified adjuvant therapy in this trial. These patients will be treated on Arm C. * Patients not categorized into the appropriate risk category will be considered ineligible for the study * Patient must be registered/randomized to Step 2 within a maximum of 7 weeks following surgery * Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception Exclusion Criteria: Registration to Surgery (Arm S) * Prior radiation above the clavicles * Evidence of extensive or "matted/fixed" pathologic adenopathy on preoperative imaging * Women must not be pregnant or breast-feeding due to the teratogenicity of chemotherapy; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) * Any intercurrent illness likely to interfere with protocol therapy or prevent surgical resection * Uncontrolled diabetes, uncontrolled infection despite antibiotics or uncontrolled hypertension within 30 days prior to pre-registration
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Boston Medical Center
Boston, Massachusetts, 02118, United States
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Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
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Case Western Reserve University
Cleveland, Ohio, 44106, United States
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City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
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Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
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Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
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Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
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Duke University Medical Center
Durham, North Carolina, 27710, United States
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Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
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Emory University/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
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Florida Hospital Orlando
Orlando, Florida, 32803, United States
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Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
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Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
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Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
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Henry Ford Hospital
Detroit, Michigan, 48202, United States
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Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
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Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287, United States
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Kaiser Permanente Oakland-Broadway
Oakland, California, 94611, United States
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
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Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
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Medical University of South Carolina
Charleston, South Carolina, 29425, United States
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Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
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Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
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Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467-2490, United States
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Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
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Oregon Health and Science University
Portland, Oregon, 97239, United States
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Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907, United States
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PinnacleHealth Cancer Center-Community Campus
Harrisburg, Pennsylvania, 17109, United States
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Porter Adventist Hospital
Denver, Colorado, 80210, United States
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Providence Portland Medical Center
Portland, Oregon, 97213, United States
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Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, 80304, United States
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Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, 80907, United States
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Sentara Cancer Institute at Sentara CarePlex Hospital
Hampton, Virginia, 23666, United States
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Sentara Hospitals
Norfolk, Virginia, 23507, United States
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Sentara Virginia Beach General Hospital
Virginia Beach, Virginia, 23454, United States
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Stanford Cancer Institute
Palo Alto, California, 94304, United States
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Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
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UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095, United States
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UCSF Medical Center-Mount Zion
San Francisco, California, 94115, United States
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UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, United States
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University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233, United States
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University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
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University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
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University of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
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University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536, United States
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University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
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University of Miami Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, 33442, United States
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University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
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University of New Mexico
Albuquerque, New Mexico, 87102, United States
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University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
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University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232, United States
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University of Virginia Cancer Center
Charlottesville, Virginia, 22908, United States
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University of Washington Medical Center
Seattle, Washington, 98195, United States
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University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
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Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
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Yale University
New Haven, Connecticut, 06520, United States
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Zablocki Veterans Administration Medical Center
Milwaukee, Wisconsin, 53295, United States
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Other studies related to the condition(s) this trial covers.