Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers - An International, Multi-Center, Double Blind, Randomized Placebo Controlled Phase III Trial
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,587
- 试验地点
- 67
- 主要终点
- Disease-free survival
研究概览
简要总结
We hypothesize through this randomized, placebo-controlled adjuvant study, that Aspirin in patients with dukes C or high risk dukes B colorectal cancer (ASCOLT) can improve survival in this patient population over placebo control. If indeed found to be beneficial, because aspirin is cheap and easy to administer, it will positively impact the lives of many individuals in Asia and globally.
STUDY OBJECTIVE
To assess the effectiveness of Aspirin against placebo control in patients with dukes C or high risk dukes B colorectal cancer in terms of Disease Free Survival (DFS) and Overall Survival (OS)
Primary endpoints
- DFS among all eligible subjects (high risk Dukes B colon cancer, Dukes C colon cancer and rectal cancer patient sub-groups);
- DFS among patients with colon cancer (high-risk Dukes B and Dukes C colon cancer).
Secondary endpoints
-
Overall survival (OS) over 5 years
-
DFS and OS in
-
Chinese, Malay, Indian and other ethnic groups
-
Resected high risk Dukes B colon cancer, Dukes C colon cancer and rectal cancer sub-groups, individually
-
Compliant versus non-compliant subjects
-
PIK3CA mutated tumors (where samples are available)
详细描述
Aspirin in patients with dukes C or high risk dukes B colorectal cancer can improve survival in this patient population over placebo control.
Eligible patients will be randomized to treatment arms, using the following stratification factors:
- Study Centre
- Tumour Type
- Type of adjuvant chemotherapy received(exposed/not exposed to oxaliplatin
Patients will be randomized over a 5 years' time period. After randomization, patient will have 3 monthly assessments with treatment for 3 years followed by 6 monthly assessments for additional 2 years follow-up
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
- Triple (Participant, Care Provider, 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
acetylsalicylic acid
200mg OD for 3 years
干预措施: Acetylsalicylic acid (Drug)
Placebo
200mg OD for 3 years
干预措施: placebo (Other)
结局指标
主要结局
Disease-free survival
时间窗: 5 years
Recurrence data documented
次要结局
- Overall survival(5 years)
研究者
Toh Han Chong
Prof
National Cancer Centre, Singapore