Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers
Status:
Active, not recruiting
Trial end date:
2026-06-01
Target enrollment:
Participant gender:
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)
Phase:
Phase 3
Details
Lead Sponsor:
National Cancer Centre, Singapore
Collaborators:
Australasian Gastro-Intestinal Trials Group INDOX Cancer Research Network University of Oxford