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)
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
St Vincent's Hospital
🇦🇺Sydney, New South Wales, Australia
Royal Brisbane and Women's Hospital
🇦🇺Herston, Queensland, Australia
Wan Fang Hospital
🇨🇳Taibei, Taiwan, China
Sir Charles Gairdner Hospital
🇦🇺Nedlands, Western Australia, Australia
St John of God Hospital Subiaco
🇦🇺Subiaco, Western Australia, Australia
All India Institute of Medical Sciences
🇮🇳New Delhi, India
Ballarat Regional Integrated Cancer Centre
🇦🇺Ballarat, Victoria, Australia
Barwon Health Andrew Love Cancer Centre
🇦🇺Geelong, Victoria, Australia
Royal Hobart Hospital
🇦🇺Hobart, Tasmania, Australia
St John of God Healthcare Southwest Oncology
🇦🇺Warrnambool, Victoria, Australia
Tan Tock Seng Hospital
🇸🇬Singapore, Singapore
Sarawak General Hospital
🇲🇾Kuching, Sarawak, Malaysia
National Cancer Institute
🇱🇰Maharagama, Sri Lanka
Nizam's Institute of Medical Sciences
🇮🇳Hyderabad, India
Hospital Kuala Lumpur
🇲🇾Kuala Lumpur, Malaysia
Tata Memorial Hospital
🇮🇳Mumbai, India
Christian Medical College and Hospital
🇮🇳Vellore, India
University of Malaysia Medical Center
🇲🇾Kuala Lumpur, Malaysia
University Kebangsaan Malaysia Medical Center
🇲🇾Kuala Lumpur, Malaysia
National Cancer Centre - Singapore
🇸🇬Singapore, Singapore
Johns Hopkins Singapore International Medical Center
🇸🇬Singapore, Singapore
Bankstown-Lidcombe Hospital Bankstown Cancer Centre
🇦🇺Bankstown, New South Wales, Australia
Orange Health Service
🇦🇺Orange, 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
Port Macquarie Base Hospital North Coast Cancer Institute
🇦🇺Port Macquarie, New South Wales, Australia
The Tweed Hospital
🇦🇺Tweed Heads, New South Wales, Australia
Northern Cancer Institute, St Leonards
🇦🇺St Leonards, New South Wales, Australia
Northwest Cancer Centre Tamworth Hospital
🇦🇺Tamworth, New South Wales, Australia
Calvary Mater Newcastle Hospital
🇦🇺Waratah, New South Wales, Australia
Toowoomba Hospital
🇦🇺Toowoomba, Queensland, Australia
Townsville Hospital
🇦🇺Douglas, Queensland, Australia
Lyell McEwin Hospital
🇦🇺Elizabeth Vale, South Australia, Australia
Border Medical Oncology Research Unit
🇦🇺Albury, Victoria, Australia
Austin Health Cancer Clinical Trials
🇦🇺Heidelberg, Victoria, Australia
Launceston General Hospital
🇦🇺Launceston, Victoria, Australia
The First People's Hospital of Foshan City
🇨🇳Foshan, Guangdong, China
Beijing University Cancer Hospital
🇨🇳Beijing, Beijing, China
Guangdong General Hospital
🇨🇳Guangzhou, Guangdong, China
Sun Yat Sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Sixth Affiliated Hospital
🇨🇳Guangzhou, Guangdong, China
Zhongshan City People's Hospital
🇨🇳Zhongshan, Guangdong, China
Affiliated Hospital of Nantong University
🇨🇳Nantong, Jiangsu, China
Yantai Yuhuangding Hospital
🇨🇳Yantai, Shandong, China
Koo Foundation Sun Yat Sen Cancer Centre
🇨🇳Taibei, Taiwan, China
Jinan Central Hospital
🇨🇳Jinan, Shandong, China
Shuang Ho Hospital
🇨🇳Taibei, Taiwan, China
The Second Affiliated Hospital of Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
Taipei Medical University Hospital
🇨🇳Taibei, Taiwan, China
Kidwai Memorial Institute of Oncology
🇮🇳Bangalore, India
Queen Mary Hospital - Hong Kong
🇨🇳Hong Kong, China
G. Kuppuswamy Naidu Memorial Hospital
🇮🇳Coimbatore, India
Regional Cancer Center
🇮🇳Trivandrum, India
Dharmais Cancer Hospital
🇮🇩Jakarta, Indonesia
Hallym University Sacred Heart Hospital
🇰🇷Anyang-si, Gyeonggi-do, Korea, Republic of
Cipto Mangunkusumo General Hospital
🇮🇩Jakarta, Indonesia
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Rumah Sakit RSUP Dr. Sardjito
🇮🇩Yogyakarta, Indonesia
Christchurch Public Hospital
🇳🇿Christchurch, New Zealand
Dunedin Hospital
🇳🇿Dunedin, New Zealand
King Fahad Medical City
🇸🇦Riyadh, Saudi Arabia
Monash Health Medical Oncology
🇦🇺Melbourne, Victoria, Australia
Goulburn Valley Health
🇦🇺Shepparton, Victoria, Australia
Royal Darwin Hospital
🇦🇺Tiwi, Northern Territory, Australia