Statin Polyp Prevention Trial in Patients With Resected Colon Cancer
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 406
- 试验地点
- 584
- 主要终点
- Occurrence of ≥ 1 Adenomatous Polyp of the Colon or Rectum, Metachronous Colorectal Carcinoma, or Colon Cancer Recurrence (APMC+R)
研究概览
简要总结
RATIONALE: Rosuvastatin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving rosuvastatin after surgery may kill any tumor cells that remain after surgery. It may also keep polyps from forming or colon cancer from coming back. It is not yet known whether rosuvastatin is more effective than a placebo in treating colon cancer that was removed by surgery.
PURPOSE: This randomized phase III trial is studying rosuvastatin to see how well it works compared with placebo in treating patients with stage I or stage II colon cancer that was removed by surgery.
详细描述
OBJECTIVES:
Primary
- To compare the effect of rosuvastatin vs placebo on the 5-year occurrence of adenomatous polyps of the colon or rectum, metachronous colorectal carcinoma, or colon cancer recurrence (APMC+R) in patients with resected stage I or II colon cancer.
Secondary
- To determine whether the effect of rosuvastatin vs placebo is of the same magnitude in patients taking aspirin (regardless of dose) compared to patients not taking aspirin.
- To determine whether taking aspirin (regardless of dose) vs no aspirin will decrease the occurrence or APMC+R and, if there is an effect, to explore the relationship to dose.
- To determine the effect of rosuvastatin in patients with familial colorectal cancer.
- To determine the effect of rosuvastatin in patients with microsatellite unstable tumors (i.e., tumors displaying loss of MLH1 or MSH2 expression by IHC).
- To determine the relationship between rosuvastatin therapy and features of colorectal adenomas as well as the size and number of colorectal adenomas.
- To compare the time to APMC+R in patients treated with rosuvastatin vs placebo.
- To compare the disease-free survival of patients treated with rosuvastatin vs placebo.
- To compare the overall survival of patients treated with rosuvastatin vs placebo.
- To compare the rate of recurrence of colon cancer in patients treated with rosuvastatin vs placebo.
- To compare the rate of second non-colorectal primary cancers in patients treated with rosuvastatin vs placebo.
- To determine the effect of rosuvastatin on health-related quality of life, global quality of life, and self-reported symptoms.
- To compare the incidence and severity of adverse events associated with rosuvastatin vs placebo.
- To assess relevant tumor and blood markers that may affect the metabolism, activity, or effect of the study drugs, such as HMG-CoA reductase, UGT1A6, P450-2C9, PTGS2 (COX-2), and other possible markers.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group 1: placebo
Patients receive oral placebo once daily for 5 years.
干预措施: placebo (Other)
Group 2: rosuvastatin
Patients receive oral rosuvastatin once daily for 5 years.
干预措施: rosuvastatin (Drug)
结局指标
主要结局
Occurrence of ≥ 1 Adenomatous Polyp of the Colon or Rectum, Metachronous Colorectal Carcinoma, or Colon Cancer Recurrence (APMC+R)
时间窗: Up to 4.8 years
Percentage of patients with occurrence of APMC+R event. APMC+R events include at least one adenomatous polyp of the colon or rectum, metachronous colorectal carcinoma, or colon cancer recurrence
次要结局
- Size of Colorectal Adenomas, Including Advanced Adenomas(Up to 4.8 years)
- Disease-free Survival(Up to 4.8 years)
- Overall Survival (OS)(Up to 4.8 years)
- Recurrence-free Interval (RFI)(Up to 4.8 years)
- Second Non-colorectal Primary Cancer-free Interval(Up to 4.8 years)
- Behavioral and Health Outcomes as Measured by SF-12 Component Scores, Global Quality-of-life Scale, and Symptom Checklist(12-month time point)
- Toxicity Assessed by Adverse Events(Up to 4.8 years)
- Measurements of Relevant Tumor and Blood Markers(At randomization)