Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers
ASCOLT
3 other identifiers
interventional
1,587
10 countries
67
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 colorectal-cancer
Started Dec 2008
Longer than P75 for phase_3 colorectal-cancer
67 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2007
CompletedFirst Posted
Study publicly available on registry
November 30, 2007
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedFebruary 2, 2024
January 1, 2024
15.5 years
November 29, 2007
January 31, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease-free survival
Recurrence data documented
5 years
Secondary Outcomes (1)
Overall survival
5 years
Study Arms (2)
acetylsalicylic acid
EXPERIMENTAL200mg OD for 3 years
Placebo
PLACEBO COMPARATOR200mg OD for 3 years
Interventions
Eligibility Criteria
You may qualify if:
- Male or female outpatient of ≥ 18 years of age or ≥ country's legal age for adult consent
- Dukes C colon cancer, high risk Dukes B colon cancer, Dukes B rectal cancer or Dukes C rectal cancer (see Appendix 1 for definition of High Risk Dukes B)
- Undergone complete resection of primary tumour
- Completed standard therapy ( at least 3 months of chemotherapy ± radiotherapy )
- Within 120 days of completion of standard therapy (surgery, chemotherapy ± radiotherapy)
- ECOG performance status 0 to 2
- Satisfactory haematological or biochemical functions (tests should be carried out within 8 weeks prior to randomisation): Results of clinical investigations carried out within 8 weeks prior to randomisation can be used in place of the required screening investigations. Patients with mild laboratory abnormalities can be included at the discretion by the site principal investigator, and after approval by ASCOLT Trial Management Group
- ANC ≥ 1.0 x 109/L
- Platelets ≥ 100 x 109/L
- Creatinine clearance ≥ 30 mL/min
- Total bilirubin ≤ 2.0 x the upper limit normal
- AST \& ALT ≤ 5 x the upper limit normal
- Completed the following investigations
- Colonoscopy(or CT colonogram(within 16 months prior to randomization)
- Imaging of abdomen (CT or CT colonogram or MRI or PET or Ultrasound) within 16 months prior to randomization
- +1 more criteria
You may not qualify if:
- Pre-existing Familial adenomatous polyposis, inflammatory bowel disease or ulcerative colitis
- Active gastritis or active peptic ulcer
- History of continuous daily use of PPI more than 1 year prior to consent
- Gastrointestinal bleeding within the past one year
- Haemorrhagic diathesis (i.e. haemophilia)
- Uncontrolled hypertension (untreated systolic blood pressure \> 160 mmHg, or diastolic blood pressure \> 95 mmHg)
- History of recent cancers (except for colorectal cancers, non-melanoma skin cancers, basal cell carcinomas, squamous cell carcinomas) in the past 5 years
- History of stroke, coronary arterial disease, angina, or vascular disease
- Patients who are on current long term treatment (≥ 4 consecutive weeks) with Aspirin, NSAID or Cox-2 inhibitors
- History of erosive GERD or active erosive GERD on gastroscopy.
- Patient on active current treatment of antiplatelet agents (i.e. off-study Aspirin, clopidogrel, ticlopidine)
- Patient receiving active treatment of anticoagulants (i.e. warfarin, low molecular weight heparins)
- Pregnant, lactating, or not using adequate contraception
- Patient having known allergy to NSAID or Aspirin
- Unexplained rise of CEA (i.e. smoker with elevated CEA will not be excluded)
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cancer Centre, Singaporelead
- Australasian Gastro-Intestinal Trials Groupcollaborator
- INDOX Cancer Research Networkcollaborator
- University of Sydneycollaborator
Study Sites (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, 2050, Australia
Coffs Harbour Health Campus North Coast Cancer Institute
Coffs Harbour, New South Wales, 2450, Australia
Central Coast Cancer Centre Gosford Hospital
Gosford, New South Wales, 2050, Australia
Newcastle private Hospital
New Lambton Heights, New South Wales, 2305, Australia
Orange Health Service
Orange, New South Wales, Australia
Port Macquarie Base Hospital North Coast Cancer Institute
Port Macquarie, New South Wales, 2444, Australia
Northern Cancer Institute, St Leonards
St Leonards, New South Wales, 2065, Australia
St Vincent's Hospital
Sydney, New South Wales, Australia
Northwest Cancer Centre Tamworth Hospital
Tamworth, New South Wales, 2340, Australia
The Tweed Hospital
Tweed Heads, New South Wales, Australia
Calvary Mater Newcastle Hospital
Waratah, New South Wales, Australia
Royal Darwin Hospital
Tiwi, Northern Territory, Australia
Townsville Hospital
Douglas, Queensland, 4814, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Toowoomba Hospital
Toowoomba, Queensland, Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, 5112, Australia
Royal Hobart Hospital
Hobart, Tasmania, 7000, Australia
Border Medical Oncology Research Unit
Albury, Victoria, Australia
Ballarat Regional Integrated Cancer Centre
Ballarat, Victoria, 3350, Australia
Barwon Health Andrew Love Cancer Centre
Geelong, Victoria, Australia
Austin Health Cancer Clinical Trials
Heidelberg, Victoria, Australia
Launceston General Hospital
Launceston, Victoria, Australia
Monash Health Medical Oncology
Melbourne, Victoria, 3165, Australia
Goulburn Valley Health
Shepparton, Victoria, 3630, Australia
St John of God Healthcare Southwest Oncology
Warrnambool, Victoria, 3280, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
St John of God Hospital Subiaco
Subiaco, Western Australia, Australia
Beijing University Cancer Hospital
Beijing, Beijing Municipality, China
The First People's Hospital of Foshan City
Foshan, Guangdong, China
Guangdong General Hospital
Guangzhou, Guangdong, China
Sixth Affiliated Hospital
Guangzhou, Guangdong, China
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, China
Zhongshan City People's Hospital
Zhongshan, Guangdong, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
Jinan Central Hospital
Jinan, Shandong, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Shuang Ho Hospital
Taibei, Taiwan, 23561, China
Koo Foundation Sun Yat Sen Cancer Centre
Taibei, Taiwan, China
Taipei Medical University Hospital
Taibei, Taiwan, China
Wan Fang Hospital
Taibei, Taiwan, China
The Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
Queen Mary Hospital - Hong Kong
Hong Kong, China
Kidwai Memorial Institute of Oncology
Bangalore, 560029, India
G. Kuppuswamy Naidu Memorial Hospital
Coimbatore, 641 037, India
Nizam's Institute of Medical Sciences
Hyderabad, 500 082, India
Tata Memorial Hospital
Mumbai, 400012, India
All India Institute of Medical Sciences
New Delhi, 110029, India
Regional Cancer Center
Trivandrum, 695011, India
Christian Medical College and Hospital
Vellore, 632002, India
Dharmais Cancer Hospital
Jakarta, 11420, Indonesia
Cipto Mangunkusumo General Hospital
Jakarta, Indonesia
Rumah Sakit RSUP Dr. Sardjito
Yogyakarta, 55284, Indonesia
Sarawak General Hospital
Kuching, Sarawak, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, 50586, Malaysia
University of Malaysia Medical Center
Kuala Lumpur, 59100, Malaysia
University Kebangsaan Malaysia Medical Center
Kuala Lumpur, Malaysia
Christchurch Public Hospital
Christchurch, 8140, New Zealand
Dunedin Hospital
Dunedin, New Zealand
King Fahad Medical City
Riyadh, 11525, Saudi Arabia
National Cancer Centre - Singapore
Singapore, 169610, Singapore
Johns Hopkins Singapore International Medical Center
Singapore, Singapore
Tan Tock Seng Hospital
Singapore, Singapore
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, South Korea
Severance Hospital
Seoul, South Korea
National Cancer Institute
Maharagama, Sri Lanka
Related Publications (4)
Segelov E, Prenen H, Day D, Macintyre CR, Foo EMJ, Ali R, Wang Q, Wei X, Lopes GL Jr, Ding K, Chen G, Chia JWK, Toh HC; ASCOLT Investigators. Impact of the COVID-19 Epidemic on a Pan-Asian Academic Oncology Clinical Trial. JCO Glob Oncol. 2020 Apr;6:585-588. doi: 10.1200/GO.20.00072. No abstract available.
PMID: 32293940BACKGROUNDDay D, Toh HC, Ali R, Foo EMJ, Simes J, Chia JWK, Segelov E; ASCOLT Investigators. Operational Challenges of an Asia-Pacific Academic Oncology Clinical Trial. JCO Glob Oncol. 2023 Jun;9:e2300040. doi: 10.1200/GO.23.00040.
PMID: 37364220BACKGROUNDChia JWK, Segelov E, Deng Y, Ho GF, Wang W, Han S, Sharma A, Ding K, Chen G, Jeffery MG, Tham CK, Ahn JB, Nott L, Zielinski R, Chao TY, van Hagen T, Wei PL, Day F, Mehta S, Yau T, Peng J, Hayes TM, Li Y, Gandhi M, Foo EMJ, Rahman N, Rothwell P, Ali R, Simes J, Toh HC. Aspirin after completion of standard adjuvant therapy for colorectal cancer (ASCOLT): an international, multicentre, phase 3, randomised, double-blind, placebo-controlled trial. Lancet Gastroenterol Hepatol. 2025 Mar;10(3):198-209. doi: 10.1016/S2468-1253(24)00387-X. Epub 2025 Jan 14.
PMID: 39824200DERIVEDAli R, Toh HC, Chia WK; ASCOLT Trial Investigators. The utility of Aspirin in Dukes C and High Risk Dukes B Colorectal cancer--the ASCOLT study: study protocol for a randomized controlled trial. Trials. 2011 Dec 14;12:261. doi: 10.1186/1745-6215-12-261.
PMID: 22168568DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
John Chia, MBBS, MRCP
National Cancer Centre, Singapore
- STUDY CHAIR
Raghib Ali, MBBS,MRCP
NYU
- STUDY CHAIR
Han Chong Toh, MD,MBBS,MRCP
National Cancer Centre, Singapore
- STUDY CHAIR
Eva Segelov, MBBS,PhD
Monash University, University of Bern
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof
Study Record Dates
First Submitted
November 29, 2007
First Posted
November 30, 2007
Study Start
December 1, 2008
Primary Completion
June 1, 2024
Study Completion
June 1, 2024
Last Updated
February 2, 2024
Record last verified: 2024-01