Head Neck CancerPhase 2CAPTURENCT07254962
CApecitabine Prior to TUmor Resection in Ent Oncology (CAPTURE)
A Phase 2 study testing Capecitabine in people with Head Neck Cancer and Mouth Cancer, run by Sir Mortimer B. Davis - Jewish General Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head Neck Cancer, Mouth Cancer, Throat Cancer
- What is being tested?
- Capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Jan 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Marco Mascarella, Assistant Professor of Otolaryngology, MD, MSc, PhD contact
About this study
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
- Being tested
- Capecitabine, Standard of Care (SOC)
- Keywords
- window of opportunity, surgery, neoadjuvant, capecitabine, Head and neck cancer, HPV-negative
- Medical subject headings
- Head and Neck Neoplasms, Mouth Neoplasms, Laryngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Patients will receive fixed-dose capecitabine prior to surgery
Standard of Care (SOC)Other
Standard of care (no intervention until surgery)
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Patients will receive standard of care surgery (no intervention prior to surgery) Receives: Other: Standard of Care (SOC) |
| Capecitabine | Experimental | Patients will receive capecitabine prior to surgery Receives: Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From initiation of capecitabine to surgery
Secondary outcomes (1)
Treatment toxicity (grade 3 or greater)
CTCAE version 5 grade 3 or greater
Measured: Within first 60 days of treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre, Lady Davis Institute
- Responsible party
- Principal investigator, Marco Mascarella, Sir Mortimer B. Davis - Jewish General Hospital
- Investigators
- Marco Mascarella, MD, MSc, PhD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254962
- Sponsor's protocol ID
- MP-37-2026-12048
- Acronym
- CAPTURE
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CApecitabine Prior to TUmor Resection in Ent Oncology (CAPTURE)
- ClinicalTrials.gov ID
- NCT07254962
- Acronym / sponsor ID
- CAPTURE / MP-37-2026-12048
- Conditions
- Head Neck Cancer, Mouth Cancer, Throat Cancer, Larynx Cancer, Skin Cancer Face
- Keywords
- window of opportunity, surgery, neoadjuvant, capecitabine, Head and neck cancer, HPV-negative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General HospitalUniversity, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre, Lady Davis Institute
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2031 (estimated)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Other: Standard of Care (SOC)Patients will receive standard of care surgery (no intervention prior to surgery) |
| Capecitabine | Experimental | Drug: CapecitabinePatients will receive capecitabine prior to surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- • Previously untreated, histologically confirmed non-HPV related HNSCC and radiologically or histologically confirmed stage I or IVA (AJCC 8th edition).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapecitabinePatients will receive fixed-dose capecitabine prior to surgery | Drug | Capecitabine |
| Standard of Care (SOC)Standard of care (no intervention until surgery) | Other | Standard of Care |
Primary outcome
Pathologic response
Time frame: From initiation of capecitabine to surgery
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
1 secondary outcome
Treatment toxicity (grade 3 or greater)
Time frame: Within first 60 days of treatment initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marco Mascarella, Assistant Professor of Otolaryngology, MD, MSc, PhD contact
Marco Mascarella, MD, MSc, PhD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capecitabine in people with Head Neck Cancer and Mouth Cancer, run by Sir Mortimer B. Davis - Jewish General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marco Mascarella, Assistant Professor of Otolaryngology, MD, MSc, PhD (514-934-1934, marco.mascarella@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic response (time frame: From initiation of capecitabine to surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.