NCT00565708

Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers

Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers - An International, Multi-Center, Double Blind, Randomized Placebo Controlled Phase III Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,587 (actual)
• Sponsor: National Cancer Centre, Singapore · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
OTHER	placebo	Placebo Comparator
DRUG	Acetylsalicylic acid	Adjuvant Therapy

Timeline

• Start date: 2008-12-01
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2007-11-30
• Last updated: 2024-02-02

Locations

67 sites across 10 countries: Australia, China, India, Indonesia, Malaysia, New Zealand, Saudi Arabia, Singapore, South Korea, Sri Lanka