Phase IIb/III Chemoprevention Trial of Celecoxib to Prevent Recurrence of Superficial Bladder Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Time to recurrence
研究概览
简要总结
This randomized phase IIb/III trial is studying celecoxib to see how well it works in preventing disease recurrence in patients who have bladder cancer. Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of celecoxib may be an effective way to prevent the recurrence of bladder cancer
详细描述
OBJECTIVES:
I. Compare the time to recurrence after treatment with celecoxib vs placebo in patients with superficial transitional cell carcinoma of the bladder at high risk for recurrence.
II. Correlate the modulation of one or more biomarkers with recurrence of bladder cancer and confirm the value of the marker(s) as a surrogate endpoint biomarker for bladder cancer and celecoxib.
III. Determine the toxicity of celecoxib in these patients. IV. Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to center and presence of Tis disease (yes vs no). Patients are randomized to one of two arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I (celecoxib)
Patients receive oral celecoxib twice daily.
干预措施: celecoxib (Drug)
Arm II (placebo)
Patients receive oral placebo twice daily.
干预措施: placebo (Drug)
结局指标
主要结局
Time to recurrence
时间窗: 3 years
次要结局
- Correlation of biomarkers with tumor recurrence(3 years)
- Modulation of biomarkers(3 years)
- Adverse events as measured by NCI CTC v2.0(3 years)
- Quality of life as measured by EORTC QLQ-C30 v3.0(Up to 24 months)