Aspirin in Preventing Colorectal Cancer in Patients at Increased Risk of Colorectal Cancer

Phase 2 Completed 79 enrolled National Cancer Institute (NCI)

RandomizedParallel-groupDouble-blindPrevention

Summary

This randomized phase II trial is studying how well aspirin works in preventing colorectal cancer in patients at increased risk of colorectal cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of aspirin may prevent colorectal cancer.

Timeline

Start: 2007-03
Primary completion: 2009-12
Completion: 2011-08

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Acetylsalicylic Acid vs Placebo; p = 0.11; Wilcoxon (Mann-Whitney) NCT00468910 ↗

registry analysis (superiority or other test); Acetylsalicylic Acid vs Placebo; p = 0.17; Wilcoxon (Mann-Whitney) NCT00468910 ↗

Publications

Roy HK, Turzhitsky V, Wali R, Radosevich AJ, Jovanovic B, Della'Zanna G, Umar A, Rubin DT, Goldberg MJ, Bianchi L, De La Cruz M, Bogojevic A, Helenowski IB, Rodriguez L, Chatterton R, Skripkauskas S, Page K, Weber CR, Huang X, Richmond E, Bergan RC, Backman V. Spectral biomarkers for chemoprevention of colonic neoplasia: a placebo-controlled double-blinded trial with aspirin. Gut. 2017 Feb;66(2):285-292. doi: 10.1136/gutjnl-2015-309996. Epub 2015 Oct 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aspirin	Small molecule	325 mg	Oral