New study aims to cut side effects in throat cancer treatment

NCT ID NCT05800574

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase II trial is testing whether giving radiation only to the side of the neck where the cancer is found can reduce dry mouth and other side effects in people with HPV-positive oropharynx cancer. About 22 participants will receive radiation (with or without chemotherapy) to just one side of the neck. The main goal is to see if the cancer stays away from the untreated side within a year after treatment.

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 and cisplatin chemotherapy
What this could lead to
If successful, this approach could reduce long-term dry mouth and other side effects for patients with HPV-related throat cancer, while still controlling the disease.
What could go wrong
This is a small, early-phase study with only 22 participants, so results may not apply to everyone. There is a risk that cancer could spread to the untreated side of the neck.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 22 people

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

Started

Mar 2023

Expected to finish

Sep 2027

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

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: * Pathologically confirmed squamous cell carcinoma of the oropharynx * Patients to be treated with bilateral neck radiation per current guidelines must have either present (see below): * Nodal status (based on staging manual, AJCC (American Joint Committee on Cancer) 8th ed.): N0 (provided the tumor is within 1cm of midline) N1\> 1 lymph nodes (on the same side of the neck as the primary cancer) or cN3 (cranial nerve III) with no contralateral neck adenopathy * Tumor stage T1-2 that approaches within 1 cm but does not cross midline as appreciated radiographically and/or by the treating radiation oncologist or a head and neck surgeon * CT with contrast and/or MRI with contrast performed within 56 days prior to registration that does not demonstrate bilateral neck adenopathy. In the setting of medical contraindication to both CT and MRI contrast please contact the study PI * PET/CT performed with 28 days prior to registration that does not demonstrate bilateral neck adenopathy. * Immunohistochemical staining for p16 that demonstrates moderate to severe staining in at least 70% of cells. * Patients must provide their smoking history prior to registration. Number of pack-years = \[Frequency of smoking (number of cigarettes per day) x duration of cigarette smoking (years)\]/20 * Patients must have clinically and/or radiographically evident disease that can be accurately measured in accordance with RECIST criteria v. 1.1. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1 within 56 days prior to registration * Age ≥ 18 years. * Adequate hematologic function within 14 days prior to registration * Adequate renal function within 14 days prior to registration * Adequate hepatic function within 14 days prior to registration Exclusion Criteria: * Tumors that cross midline, regardless of T stage * N2 adenopathy (bilateral neck adenopathy) * Gross total excision of the primary site in a diagnostic procedure prior to either imaging and/or physical examination by registering physician. * p16-negative squamous cell carcinoma * Definitive clinical or radiologic evidence of metastatic disease or adenopathy below the clavicles * Prior systemic therapy for the study cancer * Prior head and neck cancer surgery that involved the neck (includes excisional biopsy) * Prior radiation therapy to the head and neck that would result in overlap of treated fields * History of allergic reaction attributed to Technetium-99m-tilmanocept used in lymphoscintigraphy * Uncontrolled intercurrent illness including, but not limited to, any other malignancy, other 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. * Pregnant or breast feeding

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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

  • Fox Chase Cancer Center

    RECRUITING

    Philadelphia, Pennsylvania, 19111, United States

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