Aspirin in Preventing Colorectal Cancer in Patients With Colorectal Adenoma

Phase 2 Active not recruiting 81 enrolled National Cancer Institute (NCI)

RandomizedParallel-groupDouble-blindPrevention

Summary

This phase IIa trial studies how well aspirin works in preventing colorectal cancer in patients with colorectal adenoma. Aspirin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Timeline

Start: 2018-01-16
Primary completion: 2023-01-31
Completion: 2026-12-24

Outcome

Missed primary endpoint

paper For the primary endpoint of decrease in the Ki-67:BCL2-associated X ratio, we could not establish equivalence for the two treatment regimens PMID 40034042 ↗

Publications

Zhu X, Chen R, Ness RM, Naik RD, Murff HJ, Zhang H, Xu Y, Benante KA, Azcarate-Peril MA, Zheng Y, Wang J, Shrubsole MJ, Su T, Mi X, Kocherginsky M, Rodriguez LM, Della'Zanna G, Richmond E, Hou L, Khan SA, Dai Q. Evaluating Intermittent Dosing of Aspirin for Colorectal Cancer Chemoprevention. Cancer Prev Res (Phila). 2025 Jun 2;18(6):321-334. doi: 10.1158/1940-6207.CAPR-24-0168.

Drugs

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