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Study of De-Intensified Radiation Therapy for HPV-Associated Head and Neck Cancer

This study is looking at whether we can safely lower the standard dose of radiation therapy after surgery for certain head and neck cancers. These cancers are linked to the human papillomavirus (HPV) and often have better cure rates. Researchers want to see if using less radiation therapy can lead to fewer side effects and a better quality of life, while still keeping cure rates high. You might be able to join if you have squamous cell carcinoma (a type of cancer) of the tonsil, base of tongue, or an unknown primary cancer with p16-positive lymph nodes, and your tumor is confirmed to be HPV-associated. The main goal is to measure how long people live without their disease returning, over two years.

Study design
This is an interventional study with a planned enrollment of 111 participants. The study is investigating different approaches to radiation therapy.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to measure disease-free survival at 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03875716

Study of De_Intensified Postoperative Radiation Therapy for HPV Associated Oropharyngeal Squamous Cell Carcinoma

Recruiting
NAAges 18+InterventionalTreatment
Dana-Farber Cancer Institute
~111 participants
Updated 2026-03-13 on ClinicalTrials.gov
What's tested:Radiation therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disease-free survival
Measured over 2 years

Conditions

Head and Neck Cancer

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Oropharyngeal Squamous Cell CarcinomaCDKN2A wt Allele

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Danielle N. Margalit, MD, MPH · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute

Who to contact

Danielle N. Margalit, MD, MPH
[email protected]
617-632-3591
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Disease-free survival2 years

    Survival without any signs or symptoms of cancer after the treatment ends.