ASCOLT

Aspirin for Dukes C and high-risk Dukes B Colorectal cancer.

The ASCOLT study will evaluate the safety and effectiveness of low-dose aspirin compared to placebo in reducing recurrence of colorectal cancer and improving survival for patients with Dukes C and high-risk Dukes B colorectal cancer.

Colorectal cancer is the second most common cancer that affects people in Australia. Surgery is one of the important treatment modality for patients with early colorectal cancer.  However, the effectiveness of such therapy depends on whether the colorectal cancer is localised.  Chemotherapy may be used to decrease the risk of cancer returning in significant number of patients after surgery.  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.

Share

Trial Status

Open

Cancer Type

Colorectal Cancer

If you think this trial is relevant to your situation, please contact your Cancer Specialist to discuss further.

Aim

The purpose of the ASCOLT study is to evaluate the safety and effectiveness of low-dose aspirin compared to placebo in reducing recurrence of colorectal cancer and improving survival for patients with Dukes C and high-risk Dukes B colorectal cancer.

Summary

Colorectal cancer is the second most common cancer that affects people in Australia. Surgery is one of the important treatment modality for patients with early colorectal cancer.  However, the effectiveness of such therapy depends on whether the colorectal cancer is localised (that is, the cancer has not spread to other organs). Chemotherapy may be used to decrease the risk of cancer returning in significant number of patients after surgery.

Aspirin is known to be helpful in preventing and treating heart and blood vessel diseases and there is growing evidence that aspirin possesses some anticancer properties. Previous studies have indicated that aspirin may prevent development of colorectal cancer and colorectal polyps. Studies on 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. ASCOLT is one of the most important gastro-intestinal cancer studies globally, and aims to determine whether aspirin can reduce colorectal cancer recurrences and improve patient survival.

The study is a randomised controlled trial of aspirin 200 mg daily for 3 years versus placebo in patients who have already completed standard therapy for colorectal cancer.

Participants will be randomly allocated to one of two groups: one group will be provided with aspirin (daily for 3 years) and the other group will be provided with a matching placebo. 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.

To find out more about this trial

Information available online at the Australian New Zealand Clinical Trial Registry (ANZCTR) here.

Participating Centres

New South Wales
Bankstown-Lidcombe Hospital
Calvary Mater- Newcastle
Campbelltown Hospital
Gosford Hospital
Chris O’Brien Lifehouse
Newcastle Private Hospital
NCCI – Coffs Harbour Health Campus
Orange Hospital
Port Macquarie Base Hospital/NCCI
Northern Cancer Institute
Tamworth Base Hospital
The Tweed Hospital
Border Medical Oncology
St Vincents Public Hospital
Northern Territory
Royal Darwin Hospital
Queensland
Townsville Hospital
Royal Brisbane and Womens Hospital
Toowoomba Hospital
South Australia
Lyell McEwin Hospital
Tasmania
Royal Hobart Hospital
Launceston General Hospital
Victoria
Andrew Love Cancer Centre
Austin Health
Ballarat Oncology & Haematology Services
Goulburn Valley Health
Monash Medical Centre
South West Healthcare
Mildura Base Hospital
St John of God Hospital, Warrnambool
Western Australia
Sir Charles Gairdner Hospital
St John of God Hospital, Subiaco
New Zealand
Christchurch Hospital
Dunedin Hospital

Trial Status

Open

Cancer Type

Colorectal Cancer

If you think this clinical trial may be relevant to your patient or to discuss further, please contact the Clinical Trial team.

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.

Publication Reference

None to date.

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:

Open Trial Recruitment Table

Participating Centres

New South Wales
Bankstown-Lidcombe Hospital
Calvary Mater- Newcastle
Campbelltown Hospital
Gosford Hospital
Chris O’Brien Lifehouse
Newcastle Private Hospital
NCCI – Coffs Harbour Health Campus
Orange Hospital
Port Macquarie Base Hospital/NCCI
Northern Cancer Institute
Tamworth Base Hospital
The Tweed Hospital
Border Medical Oncology
St Vincents Public Hospital
Northern Territory
Royal Darwin Hospital
Queensland
Townsville Hospital
Royal Brisbane and Womens Hospital
Toowoomba Hospital
South Australia
Lyell McEwin Hospital
Tasmania
Royal Hobart Hospital
Launceston General Hospital
Victoria
Andrew Love Cancer Centre
Austin Health
Ballarat Oncology & Haematology Services
Goulburn Valley Health
Monash Medical Centre
South West Healthcare
Mildura Base Hospital
St John of God Hospital, Warrnambool
Western Australia
Sir Charles Gairdner Hospital
St John of God Hospital, Subiaco
New Zealand
Christchurch Hospital
Dunedin Hospital

Key Eligibility Criteria

Please note that the information below contains only the most important inclusion and exclusion criteria and is not a comprehensive list.

Key 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.

Key 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.

Visit ANZTCR for more detailed information on inclusion/exclusion criteria and eligibility.

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.au

Principal Investigator

Professor Eva Segelov

More Information

Available online at the Australian New Zealand Clinical Trial Registry (ANZCTR) here.

Funding

Cancer Australia
Bowel Cancer Australia.