Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers

Summary

We hypothesize through this randomized, placebo-controlled adjuvant study, that Aspirin in patients with dukes C or high risk dukes B colorectal cancer (ASCOLT) can improve survival in this patient population over placebo control. If indeed found to be beneficial, because aspirin is cheap and easy to administer, it will positively impact the lives of many individuals in Asia and globally. STUDY OBJECTIVE To assess the effectiveness of Aspirin against placebo control in patients with dukes C or high risk dukes B colorectal cancer in terms of Disease Free Survival (DFS) and Overall Survival (OS) Primary endpoints * DFS among all eligible subjects (high risk Dukes B colon cancer, Dukes C colon cancer and rectal cancer patient sub-groups); * DFS among patients with colon cancer (high-risk Dukes B and Dukes C colon cancer). Secondary endpoints * Overall survival (OS) over 5 years * DFS and OS in * Chinese, Malay, Indian and other ethnic groups * Resected high risk Dukes B colon cancer, Dukes C colon cancer and rectal cancer sub-groups, individually * Compliant versus non-compliant subjects * PIK3CA mutated tumors (where samples are available)

Timeline

Start

2008-12

Primary completion

2024-06

Completion

2024-06

Outcome

Missed primary endpoint

paper hazard ratio of 0·91 [95% CI 0·73-1·13]; p=0·38). PMID 39824200 ↗

paper aspirin 200 mg daily for 3 years after completion of standard adjuvant therapy was well tolerated but did not significantly improve disease-free survival. PMID 39824200 ↗

Publications

• Background Segelov E, Prenen H, Day D, Macintyre CR, Foo EMJ, Ali R, Wang Q, Wei X, Lopes GL Jr, Ding K, Chen G, Chia JWK, Toh HC; ASCOLT Investigators. Impact of the COVID-19 Epidemic on a Pan-Asian Academic Oncology Clinical Trial. JCO Glob Oncol. 2020 Apr;6:585-588. doi: 10.1200/GO.20.00072. No abstract available.
• Background Day D, Toh HC, Ali R, Foo EMJ, Simes J, Chia JWK, Segelov E; ASCOLT Investigators. Operational Challenges of an Asia-Pacific Academic Oncology Clinical Trial. JCO Glob Oncol. 2023 Jun;9:e2300040. doi: 10.1200/GO.23.00040.
• Chia JWK, Segelov E, Deng Y, Ho GF, Wang W, Han S, Sharma A, Ding K, Chen G, Jeffery MG, Tham CK, Ahn JB, Nott L, Zielinski R, Chao TY, van Hagen T, Wei PL, Day F, Mehta S, Yau T, Peng J, Hayes TM, Li Y, Gandhi M, Foo EMJ, Rahman N, Rothwell P, Ali R, Simes J, Toh HC. Aspirin after completion of standard adjuvant therapy for colorectal cancer (ASCOLT): an international, multicentre, phase 3, randomised, double-blind, placebo-controlled trial. Lancet Gastroenterol Hepatol. 2025 Mar;10(3):198-209. doi: 10.1016/S2468-1253(24)00387-X. Epub 2025 Jan 14.
• Ali R, Toh HC, Chia WK; ASCOLT Trial Investigators. The utility of Aspirin in Dukes C and High Risk Dukes B Colorectal cancer--the ASCOLT study: study protocol for a randomized controlled trial. Trials. 2011 Dec 14;12:261. doi: 10.1186/1745-6215-12-261.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aspirin	Small molecule	200 mg	—

Indications