NCT07254962Not yet recruitingPhase 2
CApecitabine Prior to TUmor Resection in Ent Oncology (CAPTURE)
Source: ClinicalTrials.gov · Last updated 28 Nov 2025
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- First submitted
- 16 Nov 2025
- Start date
- 1 Jan 2026
- Primary completion date
- 1 Jan 2028
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General Hospital
- Diseases
- Head and neck cancer
- NCT number
- NCT07254962
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 75
- From 1 Jan 2026 to the primary completion date, 1 Jan 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous allogenic tissue/solid organ transplant.
- 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.
Other illness
- 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.
- Known severe hypersensitivity (≥ Grade 3) to capecitabine, its active substance and/or any of its excipients.
- Known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the trial.
- Known additional malignancy that is progressing or requires active treatment within the past (5 years), excluding basal cell carcinoma or cutaneous squamous cell carcinoma.
Lab values
- 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.
Other
- Known DYPD mutation.
Who the study is looking for
- • 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.