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Could less radiation be enough for HPV throat cancer? new study investigates

NCT ID NCT03777384

Knowledge-focused Sponsor: Sanford Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether a lower dose of radiation can safely treat HPV-positive oropharynx (throat) cancer in people who have never smoked or smoked very little. Researchers will follow 75 patients for up to 5 years to see if the cancer stays away and how their quality of life is affected. The goal is to find out if reducing radiation can still be effective while causing fewer side effects.

What this could mean

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

Active substance
de-escalated radiotherapy
What this could lead to
If successful, this could confirm that lower-dose radiation is safe and effective for HPV+ throat cancer in non-smokers, reducing side effects while maintaining cancer control.
What could go wrong
This is an observational study, not a randomized trial, so results may not prove cause and effect. The small size (75 people) and specific population (non-smokers) limit how broadly the findings can be applied.

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.

Participants

75 people

The number who actually took part.

Started

Oct 2018

Expected to finish

Dec 2026

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.

Who is studied

Patients with HPV positive oropharynx cancers who have minimal nicotine exposure who are not current uses (\< 10 pack year smoking history; \< 10 year history of any nicotine product \[electronic cigarette, chewing tobacco\]).

Ages

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age \> 18 years * Histologic confirmation of tumor of the oropharynx * Radiation therapy (de-escalated head and neck irradiation) decision has been made * Human Papilloma Virus (HPV) associated cancer as determined by positive p16 immunohistochemistry * HPV positivity is defined by p16 IHC staining of \> 70% of tumor cells (strong and diffuse nuclear and cytoplasmic staining) * For cases that are indeterminate or if p16 testing cannot be accurately performed, HPV positivity can be confirmed by high-risk HPV DNA Testing which covers the following HPV subtypes: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68 * \< 10 pack year smoking history OR \< 10 year nicotine use history * No current tobacco/nicotine use (including electronic cigarettes and chewing tobacco) * T1-T3, N0-N2 (AJCC8) requiring definitive therapy greater than surgery alone * Ability to provide informed written consent * Willingness to return to Sanford Cancer Center for follow-up * Life expectancy \> 12 weeks * ECOG performance status \< 3 (Appendix B) * Adequate organ function for chemotherapy and radiotherapy Exclusion Criteria: * Any of the following because the inclusion criteria require delivery of radiotherapy and chemotherapy which is known to be genotoxic, and is associated with mutagenic and teratogenic effects: pregnant women, nursing women, men or women of childbearing potential who are unwilling to employ adequate contraception. * Prior head and neck radiotherapy * Any factor precluding safe delivery of chemotherapy

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Conditions

The condition(s) this trial relates to.

Head and Neck Neoplasms oropharyngeal carcinoma oropharynx cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Oropharyngeal cancer

Contacts and locations

Locations

  • Sanford Edith Cancer Center

    Sioux Falls, South Dakota, 57104, United States

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58102, United States

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