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Could less radiation be enough for HPV throat cancer?

NCT ID NCT06554158

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is for people with HPV-positive oropharyngeal (throat) cancer who have had surgery. Researchers want to see if giving a lower dose of radiation to a smaller area (just the neck, not the original tumor site) works as well as the standard higher dose. The goal is to reduce side effects while still controlling the cancer. About 30 participants will receive this de-escalated radiation therapy and be followed for two years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
radiation therapy (lower dose, smaller field)
What this could lead to
If successful, this could allow many patients with HPV-positive throat cancer to receive less radiation, reducing long-term side effects like swallowing problems and dry mouth.
What could go wrong
This is a small, early-phase study with only 30 participants, so results may not apply to everyone. There is a risk that lower-dose radiation might not control the cancer as well as standard treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2019

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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: * 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 Criteria: * 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

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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Medstar Georgetown University Hospital

    RECRUITING

    Washington D.C., District of Columbia, 20007, United States

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