Celecoxib Polyp Prevention Trial in Participants With Resected Stage I Colon Cancer
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- To determine whether celecoxib 400 mg bid for 3 years will decrease the incidence of adenomatous polyps of the colon and rectum in participants with Stage I adenocarcinoma of the colon.
研究概览
简要总结
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. It is not yet known whether celecoxib is effective in preventing polyps in patients with colon cancer.
PURPOSE: Randomized phase III trial to study the effectiveness of celecoxib in preventing the development of polyps in patients who have undergone surgery for stage I colon cancer.
详细描述
OBJECTIVES:
Primary
- Compare celecoxib vs placebo, in terms of decreasing the incidence of adenomatous polyps of the colon and rectum, in patients with resected stage I adenocarcinoma of the colon.
Secondary
- Compare disease-free survival of patients treated with these regimens.
- Compare the effect of these regimens on self-reported symptoms and health-related quality of life of these patients.
- Compare the quality of life of patients treated with these regimens.
- Compare the benefits of celecoxib in patients with primary tumors or polyps that express cyclo-oxygenase-2 (COX-2) with those that do not express COX-2.
- Compare the expression of signaling targets such as serine/threonine AKT, extracellular signal-regulated kinase 2 (ERK2), and endoplasmic reticulum Ca+2- ATPases in the index tumor and polyps.
- Determine the toxicity and safety of celecoxib in these patients.
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 1: placebo
one placebo capsule taken orally twice a day for 3 years
干预措施: Celecoxib (Drug)
Arm 2: celecoxib
one 400 mg capsule taken orally twice a day for 3 years
干预措施: placebo (Other)
结局指标
主要结局
To determine whether celecoxib 400 mg bid for 3 years will decrease the incidence of adenomatous polyps of the colon and rectum in participants with Stage I adenocarcinoma of the colon.
时间窗: 60 months
次要结局
- To access whether celecoxib will increase disease-free survival.(60 months)
- To access whether celecoxib therapy affects self-reported symptoms and health-related quality of life.(60 months)
- To describe the quality of life in early stage colon cancer patients.(42 months)
- To evaluate if the benefits from celecoxib are more pronounced in a cohort of participants whose primary colon tumors and polyps express COX-2.(60 months)
- To examine the expression of signaling targets such as serine/threonine kinase (AKT) extracellular signal-regulated kinase (ERK2), and endoplasmic reticulum Ca2+-ATPases in the index tumor and polyps.(60 months)
- To monitor the toxicity and safety of celecoxib in this population.(60 months)