Trial Identifiers
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Scientific Title
Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers - An International, Multi-Center, Double Blind, Randomized Placebo Controlled Phase III Trial
Cooperative Group
Australasian Gastro-Intestinal Trials Group (AGITG)
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)