• ASCOLT
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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.

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

ascolt@ctc.usyd.edu.au

Principal Investigators

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

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

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

More Information

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

Funding

Cancer Australia
Bowel Cancer Australia.