Could less radiation be just as effective for HPV throat cancer?
NCT ID NCT03875716
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is for people with HPV-related throat cancer who have had surgery. It tests whether a lower, personalized dose of radiation (and sometimes chemo) can control the cancer while causing fewer side effects and improving quality of life. About 111 adults whose cancer was removed with clear margins will take part.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 111 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2019
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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: * Histologically or cytologically confirmed squamous cell carcinoma of the tonsil or base of tongue (oropharynx) or unknown primary with p16-positive cervical lymph node metastases * HPV-associated tumor as defined by: positive p16 immunohistochemistry (\>70%) OR in situ hybridization OR PCR-based methods * Eligible for curative-intent surgery with anticipated negative margins * Surgery performed at Brigham \& Women's Hospital * Age 18 or older years. * ECOG performance status 0-1 (Karnofsky ≥70%, see Appendix A) * Normal organ and marrow function as defined below: * leukocytes ≥3,000/mcL * absolute neutrophil count ≥1,000/mcL * platelets ≥100,000/mcL * total bilirubin within normal institutional limits * AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal * creatinine ≤ 1.5 times the institutional upper limit of normal OR * creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal. * Patients with ≤20 pack-years of cumulative cigarette smoking. Pack-years are calculated by multiplying the number of years smoked with the pack of cigarettes smoked per day. One pack is considered to contain 20 cigarettes. * Tumor clinical stage (AJCC 8th edition): T0 or T1 or T2 * Nodal clinical stage (AJCC 8th edition): N0 or N1 * No distant metastases. Clinical M-stage must be M0 (AJCC 8th edition). * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Prior history of head and neck cancer within 5 years. * Prior head and neck radiation * Clinically fixed or matted nodes * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Note: that HIV positive patients will be eligible. * Pregnant women are excluded from this study because of the teratogenic risks of radiation exposure to the developing fetus. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with radiation therapy and supportive care medications required for symptomatic management of head and neck cancer side effects as well as general anesthesia required for oncologic head and neck surgery, breastfeeding should be discontinued if the mother is enrolled in the study. Pregnancy status will be determined by a serum pregnancy test.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Dana Farber Cancer Institute
RECRUITINGBoston, Massachusetts, 02062, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a dental assistant keep cancer Patients' mouths healthier during radiation?
- Why do Non-Smokers get head and neck cancer? scientists probe tumor DNA
- Re-irradiation plus cetuximab targets head and neck tumors that return
- Sharper tumor maps: PET scans could tighten radiation beams
- Five days of radiation instead of weeks: a new test for head and neck cancer
- Can an online program ease the burden on cancer caregivers?