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)
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,587
Placebo Comparator
Adjuvant Therapy
Bankstown-Lidcombe Hospital Bankstown Cancer Centre
Bankstown, New South Wales, Australia
Macarthur Cancer Therapy Centre
Campbelltown, New South Wales, Australia
Chris O'Brien Lifehouse, Clinical Research Centre
Camperdown, New South Wales, Australia
Coffs Harbour Health Campus North Coast Cancer Institute
Coffs Harbour, New South Wales, Australia
Central Coast Cancer Centre Gosford Hospital
Gosford, New South Wales, Australia
Disease-free survival
Recurrence data documented
Time frame: 5 years
Overall survival
Death data documented
Time frame: 5 years
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