Rosuvastatin in Treating Patients With Stage I or Stage II Colon Cancer That Was Removed By Surgery
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|ClinicalTrials.gov Identifier: NCT01011478|
Recruitment Status : Terminated
First Posted : November 11, 2009
Last Update Posted : April 11, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Precancerous Condition||Drug: rosuvastatin Other: placebo||Phase 3|
- 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.
- 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.
OUTLINE: This is a multicenter study. Patients are stratified according to family history of a first-degree relative with colorectal cancer (yes vs no), intended aspirin dose (none vs 81 mg vs 325 mg), and adjuvant therapy for colon cancer (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Group 1: Patients receive oral placebo once daily for 5 years.
- Group 2: Patients receive oral rosuvastatin once daily for 5 years.
Patients may complete a quality-of-life questionnaire at baseline and at 6, 12, 36, 60, and 84 months.
Tumor tissue, serum, and blood samples may be collected periodically for biomarker and other analyses.
After completion of study treatment, patients are followed up periodically for up to 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||406 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Statin Polyp Prevention Trial in Patients With Resected Colon Cancer|
|Study Start Date :||March 2010|
|Primary Completion Date :||December 2014|
|Study Completion Date :||February 2015|
Placebo Comparator: Group 1: placebo
Patients receive oral placebo once daily for 5 years.
Experimental: Group 2: rosuvastatin
Patients receive oral rosuvastatin once daily for 5 years.
Other Name: Crestor
- Occurrence of ≥ 1 adenomatous polyp of the colon or rectum, metachronous colorectal carcinoma, or colon cancer recurrence (APMC+R) [ Time Frame: From start of study through 5 years ]
- Size, number, and features of colorectal adenomas, including advanced adenomas [ Time Frame: From start of study through 7 years ]
- Disease -free survival [ Time Frame: Time from randomization to colon cancer recurrence,second primary cancer, or death from any cause through 7 years ]
- Overall Survival: Time from randomization to death from any cause [ Time Frame: Time from randomization to death from any cause through 7 years ]
- Recurrence-free interval: Time from randomization to first recurrence of colon cancer [ Time Frame: Time from randomization to first recurrence of colon cancer through 7 years ]
- Second non-colorectal primary cancer-free interval [ Time Frame: Time from randomization to first occurrence of non-colorectal primary cancer through 7 years ]
- Behavioral and Health Outcomes as measured by SF-12 component scores, global quality-of-life scale, and symptom checklist [ Time Frame: Assessed at 6, 12, 36, 60, and 84 months ]
- Occurrence and grade of reported toxicities [ Time Frame: From start of study through 7 years ]
- Measurements of relevant tumor and blood markers [ Time Frame: Samples collected at start of study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01011478
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|Principal Investigator:||Norman Wolmark, MD||NSABP Foundation Inc|