CApecitabine Prior to TUmor Resection in Ent Oncology (CAPTURE)

NCT ID: NCT07254962

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2031-01-01

Brief Summary

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

Conditions

Head Neck Cancer; Mouth Cancer; Throat Cancer; Larynx Cancer; Skin Cancer Face

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of Care

Patients will receive standard of care surgery (no intervention prior to surgery)

Group Type: ACTIVE_COMPARATOR

Standard of Care (SOC)

Intervention Type: OTHER

Standard of care (no intervention until surgery)

Capecitabine

Patients will receive capecitabine prior to surgery

Group Type: EXPERIMENTAL

Capecitabine

Intervention Type: DRUG

Patients will receive fixed-dose capecitabine prior to surgery

Interventions

Capecitabine

Patients will receive fixed-dose capecitabine prior to surgery

Intervention Type: DRUG

Standard of Care (SOC)

Standard of care (no intervention until surgery)

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: collaborator

Lady Davis Institute

OTHER

Sponsor Role: collaborator

Sir Mortimer B. Davis - Jewish General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Marco Mascarella

Principal Investigator, Clinical professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marco Mascarella, MD, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

McGill University Health Centre/Research Institute of the McGill University Health Centre

Central Contacts

Marco Mascarella, Assistant Professor of Otolaryngology, MD, MSc, PhD

Role: CONTACT

marco.mascarella@mcgill.ca

514-934-1934

Other Identifiers

MP-37-2026-12048

Identifier Type: -

Identifier Source: org_study_id