Could a simple pill before surgery beat back head and neck cancer?
NCT ID NCT07254962
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 75 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2031
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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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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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.
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Other studies related to the condition(s) this trial covers.
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