Development of Novel Diagnostic Tools and Therapeutic Strategies for Oral Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Relapse-free recurrence
研究概览
简要总结
The research and development of novel anti-tumor agents in oral cancer is slow, the investigation of repositioning use of currently available drugs in clinical, such as a selective cyclooxygenase-2 (COX-2) inhibitor (Celebrex/Celecoxib) maybe a potential alternative strategy.
详细描述
Celebrex (Celecoxib) is a form of non-steroidal anti-inflammatory drug that directly targets COX-2 enzyme to block the inflammatory signaling and has been approved to treat colon cancer. In our preliminary findings, Celecoxib significantly inhibited cell growth,proliferation, migration, invasion and epithelial-mesenchymal transition programs in oral squamous cell carcinoma cell (OSCC) lines. The Institutional Review Board in China Medical University Hospital (CMUH) has approved the combination treatment of concurrent radiotherapy (RT) and/or Cisplatin with or without Celecoxib in a phase II clinical trial for relapse-free primary OSCC patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •OSCC patients with T1,2/ N0 and without pathological risk features
- •OSCC patients with T1,2/ N0,1 and pathological risk features
- •OSCC patients with T4a/ N2,3
排除标准
- •Pregnant women paitents
- •Taiwanese aboriginal patients
- •Not primary OSCC patients
- •OSCC patients with dysfunction of liver and/or kidneys
研究组 & 干预措施
Celecoxib
Combination of concurrent radiotherapy and/or Cisplatin with or without Celcoxib
干预措施: Celecoxib (Drug)
结局指标
主要结局
Relapse-free recurrence
时间窗: 3 year relapse-free recurrence
3-year follow-up after 6-month treatment of Celecoxib
次要结局
- Relapse-free survival(3 year relapse-free survival)