CApecitabine Prior to TUmor Resection in Ent Oncology (CAPTURE) (NCT07254962) | Clinical Trial Compass
Not Yet RecruitingPhase 2
CApecitabine Prior to TUmor Resection in Ent Oncology (CAPTURE)
75 participantsStarted 2026-01-01
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* Curr…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pathologic response
Timeframe: From initiation of capecitabine to surgery
Trial details
NCT IDNCT07254962
SponsorSir Mortimer B. Davis - Jewish General Hospital
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2028-01-01
Contact for this trial
Marco Mascarella, Assistant Professor of Otolaryngology, MD, MSc, PhD