Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-26 @ 10:56 AM
NCT ID:
NCT00565708
Brief 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)
Detailed Description:
Aspirin in patients with dukes C or high risk dukes B colorectal cancer can improve survival in this patient population over placebo control.
Eligible patients will be randomized to treatment arms, using the following stratification factors:
* Study Centre
* Tumour Type
* Type of adjuvant chemotherapy received(exposed/not exposed to oxaliplatin
Patients will be randomized over a 5 years' time period. After randomization, patient will have 3 monthly assessments with treatment for 3 years followed by 6 monthly assessments for additional 2 years follow-up
Study:
NCT00565708
Study Brief:
Protocol Section:
NCT00565708