De-escalation of Adjuvant Radiation for Low-Risk HPV Oropharyngeal Cancers

This study is looking at whether patients with low-risk HPV-related oropharyngeal (throat) cancer can receive a lower dose of radiation after surgery. You may be able to join if you are 18 or older, have p16+ and/or HPV+ squamous cell carcinoma of the oropharynx (throat cancer linked to human papillomavirus), and meet specific staging criteria (T1-2 N1 M0). The study will test if a lower dose of Radiation Therapy (50Gy in 25 fractions) to a smaller area works as well as standard radiation in preventing the cancer from coming back. The main goal is to see how many participants are free from cancer progression after two years. The study is currently unclear on its recruitment status and plans to enroll 30 participants.

Study design: This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 30 participants.
What's involved: Participants will undergo treatment with a lower than standard radiation dose and to a smaller than standard radiation field.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed to measure progression-free survival for two 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.

De-escalation of Adjuvant Radiation for Low-Risk HPV Oropharyngeal Cancers

Recruiting

NAAges 18+InterventionalTreatment

Georgetown University

~30 participants

Updated 2026-03-23 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

Progression Free Survival (PFS)

Measured over 2 year

Conditions

Oropharynx Cancer

Where it's being run

1 sites across 1 states

District of Columbia1

Who to contact

Peter Ahn, MD

[email protected]

(202) 444-4036

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).

pathologic stage T1-2 N1 M0 (AJCC 8th ed.) stage I or T3 N0-1 M0 stage II (AJCC 8th ed.) SCCA of the oropharynx, with ≤ 5 distinct nodes involved with tumor, ≤ 2mm ECE (extracapsular extension), ≥ 2mm surgical margins at primary site.

Karnofsky Performance Status (KPS) ≥ 60 within 8 weeks prior to registration.

neutrophil:lymphocyte ratio ≤ 5 within 8 weeks of registration.

hemoglobin count ≥ 10 within 8 weeks of registration. The patient may receive transfusion to reach this goal.

current non-smoker (at least 6 months) with ≤ 15 pack-year smoking history

start radiation within 8 weeks of resection (6 weeks preferable)

have undergone resection of the primary site with Transoral Surgery and neck dissection of at least the ipsilateral neck

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 willingness to sign a written informed consent.

Exclusion

Perineural invasion at primary site

Lymphovascular space invasion at primary site

Level 4 nodal involvement (even if resected)

Retropharyngeal nodal involvement (even if resected)

any intact, unresected disease

nodal disease pathologically invading adjacent neck musculature

Patients treated via an invasive, non-oral approach to the primary site, including jaw-splitting mandibulotomy with resection or lateral pharyngotomy

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 that is undergoing active surveillance.

Patient with extracapsular extension (ECE) who has not had a biopsy of an ipsilateral neck lymph node that demonstrated squamous cell carcinoma

What this trial measures

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

Trialytics