Colorectal Adenoma Chemoprevention Trial Using Aspirin: A Phase III Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 635
- 试验地点
- 42
- 主要终点
- Reduction in size of tumors
研究概览
简要总结
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of aspirin may be an effective way to prevent the recurrence of polyps in colorectal cancer.
PURPOSE: Randomized phase III trial to study the effectiveness of aspirin in treating patients who have stage I, stage II, or stage III colorectal cancer that has been surgically removed.
详细描述
OBJECTIVES: I. Determine whether aspirin administered at a dose of 325 mg/day will decrease the number and size of new adenomas in patients with Dukes' A/B1/B2/C colorectal cancer who have undergone curative surgical resection. II. Assess whether this dose of aspirin will increase disease-free survival in these patients.
OUTLINE: Randomized, double-blind study. Arm I: Chemoprevention. Enteric-coated Aspirin, ASA, NSC-27223. Arm II: Control. Placebo, PLCB.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 74 Years（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
Aspirin
325 mg/day PO
干预措施: aspirin (Drug)
Placebo
干预措施: placebo (Other)
结局指标
主要结局
Reduction in size of tumors
时间窗: Up to 4 years
Reduction in number of tumors
时间窗: Up to 4 years
Disease free survival
时间窗: Up to 4 years
次要结局
未报告次要终点