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Closed (no longer recruiting)Last updated: 23 October 2023

ASCOLT: This phase III trial is investigating asprin for Dukes C and high risk Dukes B colorectal cancersAspirin for Dukes C and High Risk Dukes B Colorectal Cancers - An International, Multi-Center, Double Blind, Randomized Placebo Controlled Phase III Trial

Clinical summary

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)

Conditions

This trial is treating patients with Dukes C and high risk Dukes B Colorectal Cancer.

Cancer

Bowel Cancers Bowel

Age

People18+

Phase

III

Trial Acronym

ASCOLT

More information

Trial Identifiers

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Commercial Sponsor

Australasian Gastro-Intestinal Trials Group (AGITG)

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

Eligibility

Inclusion

  • Your cancer has not spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
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