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NCT01011478 Clinical Trial

Rosuvastatin in Treating Patients With Stage I or Stage II Colon Cancer That Was Removed By Surgery

Colorectal Cancer Clinical Trial

Official title:
Statin Polyp Prevention Trial in Patients With Resected Colon Cancer

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01011478
Other study ID # NSABP-P-5
Secondary ID NSABP P-5NCI-201
Status Terminated
Phase Phase 3
First received
Last updated
Start date March 2010
Est. completion date February 2015

Study information
Verified date July 2023
Source NSABP Foundation Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• rosuvastatin

Other:
• placebo

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Sponsors (2)
Lead Sponsor Collaborator
NSABP Foundation Inc National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Boman BM, Bandos H, Wickerham DL, et al.: Statin polyp prevention trial in patients with resected colon cancer: NSABP protocol P-5. [Abstract] J Clin Oncol 30 (Suppl 15): A-TPS1615, 2012.

Outcome
Type Measure Description Time frame Safety issue
Primary Occurrence of = 1 Adenomatous Polyp of the Colon or Rectum, Metachronous Colorectal Carcinoma, or Colon Cancer Recurrence (APMC+R) 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 Up to 4.8 years
Secondary Size of Colorectal Adenomas, Including Advanced Adenomas The histologic size (diameter of adenoma into the wall of the colon; as per AJCC staging) of the largest adenoma among patients who have at least one adenoma detected. If histologic size was not available, the endoscopic size was provided. Up to 4.8 years
Secondary Disease-free Survival Number of patients with DFS event (colon cancer recurrence, second primary cancer, or death from any cause) Up to 4.8 years
Secondary Overall Survival (OS) Number of patients with the OS event (death from any cause) Up to 4.8 years
Secondary Recurrence-free Interval (RFI) Number of patients with the RFI event (First recurrence of colon cancer) Up to 4.8 years
Secondary Second Non-colorectal Primary Cancer-free Interval Number of patients with the first occurrence of non-colorectal primary cancer Up to 4.8 years
Secondary Behavioral and Health Outcomes as Measured by SF-12 Component Scores, Global Quality-of-life Scale, and Symptom Checklist Global Quality-of-life Scale score, ranges from 0 (worst imaginable health status) to 10 (best imaginable health status. 12-month time point
Secondary Toxicity Assessed by Adverse Events Percentage of patients with at least one grade 2 or higher adverse event reported. Up to 4.8 years
Secondary Measurements of Relevant Tumor and Blood Markers This study terminated early. Data on samples was not collected, the relevant analyses were not performed. At randomization
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