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Pill combo offers new hope for rural head and neck cancer patients

NCT ID NCT06997068

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study is testing whether taking three oral chemotherapy drugs together is safe and practical for patients with head and neck cancer that has returned or spread. The trial focuses on people living in rural Midwest areas, making it easier for them to participate from home. The goal is to see if this approach can control the disease and improve access to 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

Phase 2

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

Participants

About 25 people

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

Started

Jul 2025

Expected to finish

Jun 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 * Histologically confirmed diagnosis of relapsed/metastatic head and neck cancer, including oral cavity, oropharynx \[human papillomavirus (HPV) positive and negative), hypopharynx, and larynx cancer * Measurable or non-measurable disease is allowed * Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria * Non-measurable disease * NOTE: Other nonmeasurable lesions include clinically evident lesions not well visualized on imaging \[e.g., oral cavity mass readily seen on physical exam but obscured on computed tomography (CT)\], dermal metastases, and bone metastases * Prior treatment: * One of the following must be true: * Received standard 1st-line immunotherapy or chemo-immunotherapy OR * Unable to receive or refuse 1st-line therapy * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2 * Hemoglobin ≥ 9.0 g/dL (obtained 15 days prior to registration) * Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (obtained 15 days prior to registration) * Platelet count ≥ 100,000/mm\^3 (obtained 15 days prior to registration) * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained 15 days prior to registration) * Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) (obtained 15 days prior to registration) * Prothrombin time (PT)/international normalized ratio (INR)/activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy (obtained 15 days prior to registration) * Calculated creatinine clearance ≥ 45 ml/min per Chronic-Kidney Disease-Epidemiology (CKD-EPI) Creatinine Equation (obtained 15 days prior to registration) * Estimated creatinine clearance (Clcr) by the CKD-EPI Creatinine Equation (per National Kidney Foundation) (obtained 15 days prior to registration) * Negative pregnancy test done ≤ 8 days prior to registration, for persons of childbearing potential only * Provide written informed consent * Ability to complete questionnaire(s) by themselves or with assistance * Ability to swallow pills * Willing and able to adhere with the protocol schedule for the duration of the study including undergoing treatment, attending scheduled visits, and examinations Exclusion Criteria: * Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the developing fetus and newborn are unknown * Pregnant persons * Nursing persons * Persons of childbearing potential and persons able to father a child who are unwilling to employ adequate contraception * Uncontrolled intercurrent illness including, but not limited to: * Myocardial infarction ≤ 6 months prior to registration * New York Heart Association (NYHA) class III or IV heart failure * Corrected QT interval (QTc) prolongation more than 440 ms in males and 460 ms in females * Uncontrolled dysrhythmias or poorly controlled angina * History of serious ventricular arrhythmia \[ventricular tachycardia (VT) or ventricular flutter (VF)\] and/or factors that predispose to arrhythmia (e.g., heart failure, hypokalemia, family history of long QT syndrome) * Ongoing or active infection requiring systemic treatment * Active gastrointestinal bleeding * Psychiatric illness/social situations that would limit compliance with study requirements * Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy * NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial * Known hepatitis * Exception: For patients with evidence of chronic hepatitis B virus infection the hepatitis B (HepB) viral load must be undetectable on suppressive therapy, if indicated, to be eligible * Exception: Patients with a history of hepatitis C virus infection must have been treated and cured. Patients with hepatitis C virus (HCV) infection who are currently on treatment are eligible if they have an undetectable HCV viral load * Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm * Other active malignancy requiring therapy such as radiation, chemotherapy, or immunotherapy. Patients on hormonal therapy for treated breast or prostate cancer are permitted if they meet other eligibility criteria * NOTE: Patients with secondary malignancy with life expectancy ≥ 2 years are eligible * 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

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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 study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Mayo Clinic in Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

    Contact Email: •••••@•••••

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