- ASCOLT
Trial Status
Completed
Cancer Type
Colorectal Cancer
Protocol Title
ASCOLT – Aspirin for Dukes C and High-Risk Dukes B Colorectal Cancers.
An International, Multi-centre, Double Blind, Randomised Placebo Controlled Phase III Trial.
Purpose of the Study
The purpose of the ASCOLT study is to evaluate the safety and efficacy of adjuvant aspirin 200 mg versus placebo 200mg and to determine if it can improve disease-free survival and overall survival in patients with resected Dukes C or high-risk Dukes B colorectal cancer.
Eligibility Criteria
Inclusion Criteria
- Adults (18 years or over) with high-risk stage II and III colorectal cancer (Dukes C colon cancer, high-risk Dukes B colon cancer, Dukes C rectal cancer, or Dukes B rectal cancer)
- Has undergone complete resection to remove the primary tumour
- Completed at least 3 months of chemotherapy, with or without radiotherapy
- Within 120 days of completion of standard therapy (surgery or chemotherapy with or without radiotherapy)
- Satisfactory haematological or biochemical functions (tests should be carried out within 8 weeks prior to randomisation)
- Willing to follow all study requirements, including treatment, timing of required assessments and follow-up.
Exclusion Criteria
- Pre-existing bowel diseases such as familial adenomatous polyposis, inflammatory bowel disease or ulcerative colitis
- Uncontrolled blood pressure
- Allergy to aspirin
- Patients taking a proton pump inhibitor (PPI) continuously for more than 1 year
- Active gastric or peptic ulcers, or gastro-intestinal bleeding within the past one year
- History of stroke, cardiovascular or vascular disease
- Patients already taking aspirin in the long term for other medical reasons.
Contact Email
Study Chairs
Dr Mark Jeffery
Professor Eva Segelov
Detailed Information Available on
Available online at the Australian New Zealand Clinical Trial Registry (ANZCTR) please click here.
Funding
Cancer Australia
Bowel Cancer Australia
Trial Status
Completed
Cancer Type
Colorectal Cancer
Protocol Title
ASCOLT – Aspirin for Dukes C and High-Risk Dukes B Colorectal Cancers.
An International, Multi-centre, Double Blind, Randomised Placebo Controlled Phase III Trial.
Conference Presentation Reference
Segelov E, Zielinski R, Asghari R, Simes J, Yip S, Coote A, Friend C, Aiken C, Kuang JCW, Jeffery M. ASCOLT: Aspirin for Dukes C and high risk Dukes B colorectal cancers. Clinical Oncological Society of Australia 43rd Annual Scientific Meeting; 15–17 Nov 2016; Gold Coast.
Aim
The purpose of the ASCOLT study is to evaluate the safety and efficacy of adjuvant aspirin 200 mg versus placebo 200mg and to determine if it can improve disease-free survival and overall survival in patients with resected Dukes C or high-risk Dukes B colorectal cancer.
Background
ASCOLT is a phase III clinical trial to determine whether aspirin is an effective and safe treatment option in prolonging survival in patients with localised colorectal cancer.
Currently, surgery with adjuvant chemotherapy is the standard treatment for patients with localised colorectal cancer. There are currently limited alternative treatment options available if the cancer has metastasised or if surgery is unable to remove all the cancer cells.
Aspirin has been used to prevent and treat cardiovascular and vascular disease. There is growing evidence that suggests that aspirin also has some anti-cancer properties. Previous studies into large groups of patients with colorectal cancer have shown that aspirin may be able to reduce recurrence of the cancer and improve survival in patients.
The aim of ASCOLT trial is to confirm if aspirin can improve colorectal cancer patient survival. The results of the study will provide proof of the role of aspirin in providing an affordable and readily available treatment option for localised colorectal cancer after completion of standard therapy.
ASCOLT is being conducted in 12 countries throughout Asia and Australasia and will set a new standard, nationally and internationally.
Clinical Trial Design
The ASCOLT study is an international, randomised, double blind and placebo controlled phase III multi-centre trial, investigating the effect of aspirin on disease free survival and overall survival as adjuvant treatment in patients with resected stage II and III colorectal cancer.
Participants in this trial will be randomly allocated to one of the two groups. One group will be provided with aspirin 200mg (daily for 3 years) and the other group will be provided with a matching placebo 200mg (daily for 3 years).
Participants will be asked to attend clinic visits every 3 months for a period of 3 years, and thereafter every 6 months for 2 years. During this period, assessments include clinical examinations, tests for side effects of previous and current treatments, blood tests, computed tomography (CT) scans and two colonoscopies during the five-year period.
Patients Recruited
Click to access the table and view recruitment data on all AGITG open trials:
Study Chairs (Australia and New Zealand)
Dr Mark Jeffery (Christchurch Hospital, New Zealand)
Professor Eva Segelov (Monash Health, Monash University, VIC)
Contact Email
ascolt@ctc.usyd.edu.auMore Information
Available online at the Australian New Zealand Clinical Trial Registry (ANZCTR) here.
Funding
Cancer Australia
Bowel Cancer Australia.
Changing outcomes for people with gastro-intestinal cancer since 1991