CApecitabine Prior to TUmor Resection in Ent Oncology (CAPTURE)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 主要终点
- Pathologic response
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• 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.
排除标准
- •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.
- •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.
研究组 & 干预措施
Standard of Care
Patients will receive standard of care surgery (no intervention prior to surgery)
干预措施: Standard of Care (SOC) (Other)
Capecitabine
Patients will receive capecitabine prior to surgery
干预措施: Capecitabine (Drug)
结局指标
主要结局
Pathologic response
时间窗: 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
次要结局
- Treatment toxicity (grade 3 or greater)(Within first 60 days of treatment initiation)
研究者
Marco Mascarella
Principal Investigator, Clinical professor
Sir Mortimer B. Davis - Jewish General Hospital