Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers
- Conditions
- Colorectal Cancer
- Interventions
- Other: placebo
- Registration Number
- NCT00565708
- Lead Sponsor
- National Cancer Centre, Singapore
- 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1587
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo placebo 200mg OD for 3 years acetylsalicylic acid Acetylsalicylic acid 200mg OD for 3 years
- Primary Outcome Measures
Name Time Method Disease-free survival 5 years Recurrence data documented
- Secondary Outcome Measures
Name Time Method Overall survival 5 years Death data documented
Trial Locations
- Locations (67)
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
Newcastle private Hospital
🇦🇺New Lambton Heights, New South Wales, Australia
Orange Health Service
🇦🇺Orange, New South Wales, Australia
Port Macquarie Base Hospital North Coast Cancer Institute
🇦🇺Port Macquarie, New South Wales, Australia
Northern Cancer Institute, St Leonards
🇦🇺St Leonards, New South Wales, Australia
St Vincent's Hospital
🇦🇺Sydney, New South Wales, Australia
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