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Could a simple pill before surgery beat back head and neck cancer?

NCT ID NCT07254962

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether taking a short course of capecitabine pills before surgery can shrink tumors and improve outcomes for people with HPV-negative head and neck cancer. About 75 adults with stage III or IVa cancer will be randomly assigned to either standard care or capecitabine before surgery. The goal is to see if this approach reduces tumor size, makes surgery less complex, and improves cancer-free survival.

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 75 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Jan 2031

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: * • Previously untreated, histologically confirmed non-HPV related HNSCC and radiologically or histologically confirmed stage I or IVA (AJCC 8th edition). * No evidence of distant metastatic disease. * Able to undergo protocol therapy, including necessary imaging and surgery. * If female: may participate if not actively pregnancy nor breastfeeding. * If male: must agree to refrain from donating sperm and must either be abstinent or agree to use contraception. * Performance status (ECOG) of 0, 1 or 2. Exclusion Criteria: * History of immunodeficiency, HBV, HCV, HIV. No HBV, HCV or HIV testing is required unless mandated by local health authority. * Active infection requiring systemic therapy. * Previous allogenic tissue/solid organ transplant. * Known severe hypersensitivity (≥ Grade 3) to capecitabine, its active substance and/or any of its excipients. * History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator. * Known DYPD mutation. * Known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the trial. * Received prior systemic anticancer therapy including investigational agents for the current malignancy prior to allocation. * Currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of trial treatment. * Known additional malignancy that is progressing or requires active treatment within the past (5 years), excluding basal cell carcinoma or cutaneous squamous cell carcinoma.

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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

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  2. A doctor treating you

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More trials for these conditions

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