CApecitabine Prior to TUmor Resection in Ent Oncology (CAPTURE)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSir Mortimer B. Davis - Jewish General Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• 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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Capecitabine
DrugPatients will receive fixed-dose capecitabine prior to surgery
Standard of Care (SOC)
Other interventionStandard of care (no intervention until surgery)
Treatment groups
75 Participants
are divided into 2 treatment groupsGroup A: Standard of CareActive comparator 1 intervention
Group B: CapecitabineExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
From initiation of capecitabine to surgerySecondary outcomes
1
Treatment toxicity (grade 3 or greater)
CTCAE version 5 grade 3 or greater
Time frame
Within first 60 days of treatment initiationOther outcomes
1
Disease-Free Survival
Disease-Free Survival: length of time after definitive therapy during which free from cancer.
Time frame
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 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Sir Mortimer B. Davis - Jewish General Hospital
Lead sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborator
Lady Davis Institute
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: