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Treatment De-Escalation for HPV or p16-Positive Oropharyngeal Cancer

This study is looking at a new way to treat certain head and neck cancers, specifically oropharyngeal cancer (cancer of the middle part of the throat) that is linked to Human Papillomavirus (HPV) or p16. Currently, these cancers are treated with strong radiation and chemotherapy. This study wants to see if giving only radiation, and at a lower dose (66Gy), can be just as effective while causing fewer long-term side effects. We are testing if this reduced treatment can prevent the cancer from returning for at least two years. You might be able to join if you are 18 or older and have p16+ and/or HPV+ squamous cell carcinoma of the oropharynx, with early-stage disease (stage I-II). The study plans to enroll 30 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 30 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main goal is to measure how long participants live without the cancer returning, which will be checked for 2 years after treatment.

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

NCT06902623

Treatment De-Escalation for Favorable Prognosis Human Papilloma Virus (HPV) or p16-Positive Oropharyngeal Cancer Receiving Definitive Radiotherapy

Recruiting
NAAges 18+InterventionalTreatment
Georgetown University
~30 participants
Updated 2026-04-17 on ClinicalTrials.gov
What's tested:Radiation

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression Free Survival (PFS)
Measured over 2 years

Conditions

Oropharyngeal Cancers
HPV
Tonsil Cancer
Base of Tongue Cancer

Explore related trials

Oropharyngeal CarcinomaCDKN2A wt AlleleHPV

Where it's being run

2 sites across 2 states
District of Columbia1
Maryland1

Study leadership

  • Peter Ahn, MD · PRINCIPAL_INVESTIGATOR · Georgetown University

Who to contact

Peter H Ahn, MD
[email protected]
202-444-6385
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patients must be ≥ 18 years of age on the day of signing informed consent.
Patients must have a diagnosis of p16+ and/or HPV+ squamous cell carcinoma of the oropharynx (including base of tongue, glossotonsilar sulcus, tonsil, soft palate, vallecula, and/or posterior oropharyngeal wall).
clinical stage stage I-II (T1-2 N1 M0, or T3 N0-1 M0 ) (AJCC 8th ed.) SCCA of the oropharynx that would mandate definitive chemoradiation as current standard of care when standard radiation fractionation is applied. Debulking of the disease by resecting the exophytic portion of the tumor for biopsy/sample or symptom alleviation will be permitted, as long as gross unresected tumor is left behind.
Subjects must agree to biopsy of areas that are FDG-avid on PET-CT scan 3-4 months after treatment.
Patients must have Karnofsky Performance Status (KPS) ≥ 60 within 8 weeks prior to registration
Patients must have had a neutrophil:lymphocyte ratio ≤ 5 within 8 weeks of registration.
Patient must have had a hemoglobin count ≥ 10 within 8 weeks of registration. The patient may receive transfusion to reach this goal.
Patients must be a current non-smoker (at least 6 months) with ≤ 15 pack-year smoking history
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Ability to understand and the willingness to sign a written informed consent.

Exclusion

Patients with gross involvement of level 4 lymph node level
Endophytic T3 disease, as clinically determined by the principal investigator.
Patients with any single lymph node \> 4cm (multiple lymph nodes including nodal conglomerates that in sum measure \>4cm is allowed)
Patients with nodal disease clinically fixed to or radiographically invading adjacent neck musculature any single lymph node \> 4cm (multiple lymph nodes including nodal conglomerates that in sum measure \>4cm is allowed)
Prior history of malignancy diagnosed within 2 years prior to registration, except for nonmelanomatous skin cancer that has completed treatment and the patient is deemed as being disease-free, or Gleason 6 prostate cancer undergoing active surveillance.
Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.

What this trial measures

  • Progression Free Survival (PFS)2 years

    Progression Free Survival- 2-year progression free survival, as determined by standard of care physical examination and standard of care surveillance imaging.