Randomized, Phase II Trial of Atorvastatin, RAFTILOSE Synergy 1, and Sulindac Among Patients at Increased Risk for Sporadic Colorectal Neoplasia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Percent Change in Number of Rectal Aberrant Cryptic Foci (ACF) as Measured by Magnification Chromoendoscopy
研究概览
简要总结
This randomized phase II trial is studying atorvastatin calcium to see how well it works compared to oligofructose-enriched inulin, sulindac, or a placebo in preventing cancer in patients at increased risk of developing colorectal neoplasia. Chemoprevention is the use of certain drugs or substances to keep cancer from forming, growing, or coming back. The use of atorvastatin calcium, oligofructose-enriched inulin, or sulindac may stop cancer from forming in patients at increased risk of colorectal neoplasia. It is not yet known whether atorvastatin calcium, oligofructose-enriched inulin, or sulindac are more effective than a placebo in preventing cancer in patients at increased risk of developing colorectal neoplasia.
详细描述
PRIMARY OBJECTIVE:
I. Percent change in number of rectal aberrant cryptic foci (ACF) as measured by magnification chromoendoscopy
SECONDARY OBJECTIVES:
I. Screening for possible phase III testing II. Effects on proliferation (Ki67 expression) and apoptosis (caspase-3 expression) as measured by biopsy samples obtained from normal-appearing rectal mucosa at baseline and after completion of study treatment III. Correlation of endoscopic features with histologic characteristics of rectal ACF IV. Observation of the natural history of rectal ACF in patients receiving placebo V. Adverse events VI. Utilization of a biospecimen repository archive
OUTLINE: This is a multicenter, prospective, randomized, partially blinded, placebo-controlled study. Patients are stratified according to history of prior surgical resection of the colon (yes vs no) and number of rectal aberrant cryptic foci (ACF) (5-9 vs >= 10). Patients are randomized to 1 of 4 treatment 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
- 40 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 (atorvastatin calcium)
Patients receive oral atorvastatin once daily.
干预措施: atorvastatin calcium (Drug)
Arm I (atorvastatin calcium)
Patients receive oral atorvastatin once daily.
干预措施: laboratory biomarker analysis (Other)
Arm II (sulindac)
Patients receive oral sulindac twice daily.
干预措施: sulindac (Drug)
Arm II (sulindac)
Patients receive oral sulindac twice daily.
干预措施: laboratory biomarker analysis (Other)
Arm IV (placebo)
Patients receive an oral placebo twice daily.
干预措施: placebo (Drug)
Arm III (oligofructose-enriched inulin)
Patients receive oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily.
干预措施: oligofructose-enriched inulin (Drug)
Arm III (oligofructose-enriched inulin)
Patients receive oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily.
干预措施: laboratory biomarker analysis (Other)
Arm IV (placebo)
Patients receive an oral placebo twice daily.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Percent Change in Number of Rectal Aberrant Cryptic Foci (ACF) as Measured by Magnification Chromoendoscopy
时间窗: 6 months
At the Pre-Intervention Evaluation, rectal ACF will be classified with respect to ACF number, crypt number, crypt size, tissue plane, staining intensity, and (optional) lumen shape for each subject. At the Post- Intervention Evaluation, these same parameters will be recorded and incident vs prevalent rectal ACF status will also be recorded. Compare each non-placebo arms versus the placebo arm to screen the three active study agents for possible phase III testing.
次要结局
- Effects on Proliferation (Ki67 Expression).(Up to 6 months)
- Effects on Apoptosis (Caspase-3 Expression).(Up to 6 months)
- Adverse Events.(Up to 30 days after completion of study treatment)