Celecoxib for the Treatment of Non-muscle Invasive Bladder Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 58
- 主要终点
- Time to first recurrence
研究概览
简要总结
The treatment of non-muscle invasive bladder cancer (NMIBC) is problematic given the variable natural history of the disease. Although contemporary treatment options are limited, new targets and new approaches are under investigation for preventing bladder cancer recurrence and progression. Among those, COX-2 is a promising target since plays an important role in urothelial carcinogenesis and iCOX-2 selective inhibitors, like celecoxib, effectively inhibit tumor development and growth and enhances survival, in bladder cancer in vitro and in vivo models.
Therefore, the investigators conducted a pilot study of celecoxib to prevent recurrence in patients with intermediate risk NMIBC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Histologically proven urothelial bladder cancer
- •Intermediate risk NMIBC
- •ECOG Performance Status ≤ 2 or Karnofsky Score ≥ 60%
- •Imaging study excluding upper urinary tract TCC
排除标准
- •Pregnant and lactating women;
- •Advanced co-existing medical or psychiatric disorders;
- •Positive history of gastro-intestinal disease (peptic ulcer, inflammatory disease), intestinal bleeding;
- •History of allergy to sulfonamide drugs;
- •Concomitant investigational medications.
研究组 & 干预措施
ARM A
Patients undergoing treatment with oral celecoxib
干预措施: Celecoxib (Drug)
结局指标
主要结局
Time to first recurrence
时间窗: 5 years
Safety assessed by description of grade 1-4 adverse events
时间窗: 5 years
次要结局
未报告次要终点
研究者
Pagliarulo Vincenzo
Medical Doctor
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari