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New combo therapy shows promise for HPV throat cancer patients

NCT ID NCT01932697

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a treatment for people with HPV-related throat cancer. It combined a higher dose of radiation with the chemotherapy drug docetaxel. The goal was to see if this approach could better control the tumor and improve survival. The study involved 81 participants and was completed by the Mayo Clinic.

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

81 people

The number who actually took part.

Started

Sep 2013

Finished

Dec 2021

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: * PRE-REGISTRATION * Provide written informed consent * Submission of research blood draw to be stored until after surgical resection of the primary tumor and confirmation of human papilloma virus (HPV) positivity (Mayo Clinic Rochester patients only) * Patients with oropharynx carcinoma with a smoking history of ˂ 10 pack-year or equivalent 10 year history of tobacco product use and no recent history (within last 5 years) of tobacco use * REGISTRATION * Histological confirmation of HPV+ squamous cell carcinoma of the oropharynx; HPV positivity will be defined as positive staining for p16 on immunohistochemistry (IHC) * Gross total surgical resection with curative intent of the primary tumor and at least unilateral neck dissection within 7 weeks of registration * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 * Smoking history \< 10 pack years or equivalent 10 year history of tobacco product use * Absence of distant metastases on standard diagnostic work-up =\< 10 weeks prior to registration; (chest computed tomography \[CT\], chest x-ray \[CXR\], positron emission tomography \[PET\]/CT, etc.) * Must have one of the following risk factors: * Lymph node \> 3 cm * 2 or more positive lymph nodes * Perineural invasion * Lymphovascular space invasion * T3 or microscopic T4a primary disease * Lymph node extracapsular extension * Absolute neutrophil count (ANC) \>= 1500/mm\^3 * Platelet count \>= 100,000/mm\^3 * Hemoglobin \>= 9.0 g/dL * Direct bilirubin within upper limit of normal (ULN) * Creatinine =\< ULN x 1.5 * Negative pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only * Ability to complete questionnaire(s) by themselves or with assistance * Provide informed written consent * Willingness to return to enrolling institution for follow-up (during the active monitoring phase of the study) Exclusion Criteria: * Any significant tobacco history within the past five years * Any of the following: * Pregnant women * Nursing women * Men or women of childbearing potential who are unwilling to employ adequate contraception * Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens * Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive * 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 * Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm * Other active malignancy =\< 5 years prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: if there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer * History of myocardial infarction =\< 180 days prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias * Prior history of radiation therapy to the affected site * History of connective tissue disorders such as rheumatoid arthritis, lupus, or Sjogren's disease * Presence of any of the following risk factors after surgery: * Any positive surgical margin * Adenopathy below the clavicles * Prior systemic chemotherapy for the study cancer; NOTE: prior chemotherapy for a different cancer is allowable * History of allergic reaction to docetaxel * Receiving any medications or substances that are strong or moderate inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) * Use of strong or moderate inhibitors is prohibited =\< 7 days prior to registration * Receiving any medications or substances that are inducers of CYP3A4 * Use of inducers is prohibited =\< 12 days prior to registration

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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.

Contacts and locations

Locations

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259, United States

More trials for these conditions

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