Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Could less radiation be just as good for HPV throat cancer?

NCT ID NCT05387915

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether giving a lower dose of radiation after robotic surgery can help people with HPV-positive throat cancer have fewer side effects, like trouble swallowing, while still controlling the cancer. About 33 adults with this type of cancer will receive the reduced radiation and be followed for one year to check their swallowing function and cancer outcomes. The goal is to improve quality of life without making the cancer more likely to return.

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 33 people

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

Started

Jun 2022

Expected to finish

Jan 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

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. * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%). * Life expectancy \> 12 weeks as determined by the Investigator. * Has diagnosis of HPV-associated squamous cell carcinoma of the oropharynx * HPV positive either via p16 status or via in situ hybridization * This includes patients with HPV positive squamous cell carcinoma of an unknown primary of the head and neck presumed to be of oropharyngeal origin who have undergone ipsilateral palatine and lingual tonsillectomies. * pT1-2, pN0-1, cM0 disease. * Positive ctHPVDNA titer prior to surgery. * =\< 10 pack-year smoking history. * Completed transoral robotic surgery (TORS) oropharyngectomy and at least ipsilateral neck dissection by an Emory otolaryngologist. * Pathology must demonstrate at least one of the follow intermediate risk factors: * Close margin (1 - 4 mm) * Perineural invasion * Lymphovascular space invasion * 2 - 4 positive lymph nodes without extranodal extension (ENE) * A single positive lymph node \> 3 cm in size, without ENE * Pathology cannot demonstrate \> 4 positive lymph nodes, ENE, or a positive final margin (defined as \< 1 mm). Margins that have been subsequently cleared are allowed. * Radiation increases the risk of birth defects. For this reason, females of child-bearing potential (FCBP) must have a negative serum or urine pregnancy test prior to starting therapy. * FCBP and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 12 months after completion of radiation. A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months. * Willingness and ability of the subject to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions. * Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation. Exclusion Criteria: * Patients with a prior history of malignancy in the last two years (excluding non- melanomatous skin cancer). * Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier (i.e., have residual toxicities \> grade 1). * Patients who are receiving any other investigational agents or an investigational device within 21 days before administration of first dose of study drugs. * Uncontrolled intercurrent illness including, but not limited to, 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. * Significant cardiovascular disease (e.g., myocardial infarction, arterial thromboembolism, cerebrovascular thromboembolism) within 3 months prior to start of study therapy; angina requiring therapy; symptomatic peripheral vascular disease; New York Heart Association class 3 or 4 congestive heart failure; or uncontrolled grade \>= 3 hypertension (diastolic blood pressure \>= 100 mmHg or systolic blood pressure \>= 160 mmHg) despite antihypertensive therapy.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Clinical stage I HPV-mediated (P16-positive) oropharyngeal carcinoma ajcc V8 are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

Contacts and locations

Locations

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322, United States

  • Emory University Midtown Hospital

    Atlanta, Georgia, 30308, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.