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Tracking Information | |||||
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First Received Date † | June 8, 2006 | ||||
Last Updated Date | April 26, 2009 | ||||
Start Date † | March 2006 | ||||
Current Primary Outcome Measures † |
Percent change in number of rectal aberrant cryptic foci (ACF) as measured by magnification chromoendoscopy [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00335504 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
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Descriptive Information | |||||
Brief Title † | Atorvastatin, Oligofructose-Enriched Inulin, or Sulindac in Preventing Cancer in Patients at Increased Risk of Developing Colorectal Neoplasia | ||||
Official Title † | Randomized Phase II Trial of Atorvastatin, RAFTILOSE®Synergy1, and Sulindac Among Patients at Increased Risk for Sporadic Colorectal Neoplasia | ||||
Brief Summary | RATIONALE: Chemoprevention is the use of certain drugs or substances to keep cancer from forming, growing, or coming back. The use of atorvastatin, 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, oligofructose-enriched inulin, or sulindac are more effective than a placebo in preventing cancer in patients at increased risk of developing colorectal neoplasia. PURPOSE: This randomized phase II trial is studying atorvastatin 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. |
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Detailed Description | OBJECTIVES: Primary
Secondary
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.
Tissue samples are collected at baseline and at the completion of study treatment. Tissue is examined by immunohistochemistry for proliferation (Ki67) and apoptosis (cleaved caspase-3). After completion of study treatment, patients are followed at approximately 30 days. PROJECTED ACCRUAL: A total of 112 patients will be accrued for this study. |
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Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Prevention, Randomized, Double-Blind, Placebo Control | ||||
Condition † |
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Intervention † |
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Study Arms / Comparison Groups |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 112 | ||||
Completion Date | |||||
Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
NOTE: **Patients may be eligible for study treatment after discontinuing NSAIDs for 12 weeks, at the discretion of their health care provider |
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Gender | Both | ||||
Ages | 40 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States, Canada | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00335504 | ||||
Responsible Party | Paul J. Limburg, Mayo Clinic Cancer Center | ||||
Secondary IDs †† | MAYO-030103, MAYO-1395-05 | ||||
Study Sponsor † | Mayo Clinic | ||||
Collaborators †† | National Cancer Institute (NCI) | ||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | January 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |