Dukes C or high-risk Dukes B colorectal cancer
High quality evidence indicates that aspirin is effective in reducing colorectal polyps; and numerous epidemiological studies point towards an ability to prevent colorectal cancer. However, the role of Aspirin as an adjuvant agent in patients with established cancers remains to be defined.
The study team is hypothesizing 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. The study is intended 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 end points were 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).
RemediumOne is part of this project from 2014. In Sri Lanka we have cleared both ethics and regulatory submissions in 14 weeks. Globally 1587 participants are expected to get enrolled. In Sri Lanka National Cancer Institute is taking part in this project along with other 74 global locations. Currently the recruitment is ongoing globally. Primary completion date of this project is December 2025. So far, Sri Lanka has recruited 30+ participants and the retention is rate is 100%.