CApecitabine Prior to TUmor Resection in Ent Oncology (CAPTURE)

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.