NCT07254962: CAPTURE

CApecitabine Prior to TUmor Resection in Ent Oncology (CAPTURE)

Not yet recruiting Phase 2 Last updated 28 November 2025

What this trial tests

Phase 2 trial testing Capecitabine in Head Neck Cancer in 75 participants. Not yet recruiting.

Timeline

1 January 2026

Primary endpoint
1 January 2028

1 January 2031

Quick facts

Lead sponsor	Sir Mortimer B. Davis - Jewish General Hospital
Phase	Phase 2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	75
Start date	1 January 2026
Primary completion	1 January 2028
Estimated completion	1 January 2031

Drugs / interventions tested

• Capecitabine (capecitabine) — full drug profile →
• Standard of Care (SOC) — full drug profile →

Conditions studied

• Head Neck Cancer — all drugs for Head Neck Cancer →
• Mouth Cancer — all drugs for Mouth Cancer →
• Throat Cancer — all drugs for Throat Cancer →
• Larynx Cancer — all drugs for Larynx Cancer →

Sponsor

Sir Mortimer B. Davis - Jewish General Hospital

Who can join

18 and older, any sex, with Head Neck Cancer or Mouth Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.