CApecitabine Prior to TUmor Resection in Ent Oncology (CAPTURE) (CAPTURE)

head and neck squamous cell carcinoma (HNSCC) is a type of cancer that affects areas such as the mouth, throat, and voice box. Despite medical progress, little has changed in the care for patients with HPV-negative cancer. The standard care involves surgery followed by radiation or chemotherapy if needed. However, delays in starting treatment - especially beyond six weeks - are linked to worse outcomes. Many patients also experience cancer returning within two years, often making it harder to treat. This study aims to improve outcomes by giving patients a short course of capecitabine, a chemotherapy pill, before surgery. Capecitabine is easier to tolerate than traditional intravenous chemotherapy and has shown promising results in shrinking tumors. Researchers believe that starting this oral treatment early could reduce delays, shrink tumors, make surgery less complex, and improve survival. The clinical trial will randomly assign patients with newly diagnosed stage III or IVa HPV-negative head and neck cancer to receive either standard care or capecitabine before surgery. Surgery will be performed within six weeks of diagnosis, followed by additional therapy as needed. The study will measure how well the tumor responds under the microscope after surgery, how much it shrinks on scans, the safety of the treatment, and cancer-free survival at two years. It will also explore biological markers linked to treatment response.

If successful, this approach could offer a simpler, faster, and more effective way to treat head and neck cancer, leading to earlier treatment, less invasive surgery, and improved patient outcomes. The study plans to include about 62 patients to evaluate the benefits of this new treatment strategy

Study Overview

• Status: Not yet recruiting
• Conditions: Skin Cancer Face; Head Neck Cancer; Larynx Cancer; Mouth Cancer; Throat Cancer
• Intervention / Treatment: Other: Standard of Care (SOC); Drug: Capecitabine

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Marco Mascarella, Assistant Professor of Otolaryngology, MD, MSc, PhD; Phone Number: 514-934-1934; Email: marco.mascarella@mcgill.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care; Patients will receive standard of care surgery (no intervention prior to surgery)	Other: Standard of Care (SOC); Standard of care (no intervention until surgery)
Experimental: Capecitabine; Patients will receive capecitabine prior to surgery	Drug: Capecitabine; Patients will receive fixed-dose capecitabine prior to surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathologic response	modified Ryan criteria: score based on the following: no viable cancer, rare groups of cancer cells, residual cancer with tumor regression, no evident tumor regression	From initiation of capecitabine to surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment toxicity (grade 3 or greater)	CTCAE version 5 grade 3 or greater	Within first 60 days of treatment initiation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-Free Survival	Disease-Free Survival: length of time after definitive therapy during which free from cancer.	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

Collaborators and Investigators

• Sponsor: Sir Mortimer B. Davis - Jewish General Hospital
• Collaborators: McGill University Health Centre/Research Institute of the McGill University Health Centre; Lady Davis Institute
• Investigators: Principal Investigator: Marco Mascarella, MD, MSc, PhD, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2031

Study Registration Dates

• First Submitted: November 16, 2025
• First Submitted That Met QC Criteria: November 19, 2025
• First Posted (Actual): November 28, 2025

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: capecitabine; neoadjuvant; surgery; Head and neck cancer; window of opportunity; HPV-negative
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Laryngeal Diseases; Head and Neck Neoplasms; Laryngeal Neoplasms; Mouth Neoplasms; Health Services Administration; Health Care Quality, Access, and Evaluation; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleic Acids, Nucleotides, and Nucleosides; Quality of Health Care; Quality Indicators, Health Care; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Nucleosides; Uracil; Pyrimidinones; Deoxyribonucleosides; Fluorouracil; Capecitabine; Standard of Care
• Other Study ID Numbers: MP-37-2026-12048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No