Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers (ASCOLT)

January 31, 2024 updated by: Toh Han Chong, National Cancer Centre, Singapore

Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers - An International, Multi-Center, Double Blind, Randomized Placebo Controlled Phase III Trial

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)

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

1587

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Bankstown, New South Wales, Australia
        • Bankstown-Lidcombe Hospital Bankstown Cancer Centre
      • Campbelltown, New South Wales, Australia
        • Macarthur Cancer Therapy Centre
      • Camperdown, New South Wales, Australia, 2050
        • Chris O'Brien Lifehouse, Clinical Research Centre
      • Coffs Harbour, New South Wales, Australia, 2450
        • Coffs Harbour Health Campus North Coast Cancer Institute
      • Gosford, New South Wales, Australia, 2050
        • Central Coast Cancer Centre Gosford Hospital
      • New Lambton Heights, New South Wales, Australia, 2305
        • Newcastle Private Hospital
      • Orange, New South Wales, Australia
        • Orange Health Service
      • Port Macquarie, New South Wales, Australia, 2444
        • Port Macquarie Base Hospital North Coast Cancer Institute
      • St Leonards, New South Wales, Australia, 2065
        • Northern Cancer Institute, St Leonards
      • Sydney, New South Wales, Australia
        • St Vincent's Hospital
      • Tamworth, New South Wales, Australia, 2340
        • Northwest Cancer Centre Tamworth Hospital
      • Tweed Heads, New South Wales, Australia
        • The Tweed Hospital
      • Waratah, New South Wales, Australia
        • Calvary Mater Newcastle Hospital
    • Northern Territory
      • Tiwi, Northern Territory, Australia
        • Royal Darwin Hospital
    • Queensland
      • Douglas, Queensland, Australia, 4814
        • Townsville Hospital
      • Herston, Queensland, Australia
        • Royal Brisbane and Women'S Hospital
      • Toowoomba, Queensland, Australia
        • Toowoomba Hospital
    • South Australia
      • Elizabeth Vale, South Australia, Australia, 5112
        • Lyell McEwin Hospital
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Royal Hobart Hospital
    • Victoria
      • Albury, Victoria, Australia
        • Border Medical Oncology Research Unit
      • Ballarat, Victoria, Australia, 3350
        • Ballarat Regional Integrated Cancer Centre
      • Geelong, Victoria, Australia
        • Barwon Health Andrew Love Cancer Centre
      • Heidelberg, Victoria, Australia
        • Austin Health Cancer Clinical Trials
      • Launceston, Victoria, Australia
        • Launceston General Hospital
      • Melbourne, Victoria, Australia, 3165
        • Monash Health Medical Oncology
      • Shepparton, Victoria, Australia, 3630
        • Goulburn Valley Health
      • Warrnambool, Victoria, Australia, 3280
        • St John of God Healthcare Southwest Oncology
    • Western Australia
      • Nedlands, Western Australia, Australia
        • Sir Charles Gairdner Hospital
      • Subiaco, Western Australia, Australia
        • St John of God Hospital Subiaco
  • China
      • Hong Kong, China
        • Queen Mary Hospital - Hong Kong
    • Beijing
      • Beijing, Beijing, China
        • Beijing University Cancer Hospital
    • Guangdong
      • Foshan, Guangdong, China
        • The First People's Hospital of Foshan City
      • Guangzhou, Guangdong, China
        • Guangdong General Hospital
      • Guangzhou, Guangdong, China
        • Sun Yat Sen University Cancer Center
      • Guangzhou, Guangdong, China
        • Sixth Affiliated Hospital
      • Zhongshan, Guangdong, China
        • Zhongshan City People's Hospital
    • Jiangsu
      • Nantong, Jiangsu, China
        • Affiliated Hospital of Nantong University
    • Shandong
      • Jinan, Shandong, China
        • Jinan Central Hospital
      • Yantai, Shandong, China
        • Yantai Yuhuangding Hospital
    • Taiwan
      • Taibei, Taiwan, China, 23561
        • Shuang Ho Hospital
      • Taibei, Taiwan, China
        • Koo Foundation Sun Yat Sen Cancer Centre
      • Taibei, Taiwan, China
        • Taipei Medical University Hospital
      • Taibei, Taiwan, China
        • Wan Fang Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • The Second Affiliated Hospital of Zhejiang University
  • India
      • Bangalore, India, 560029
        • Kidwai Memorial Institute of Oncology
      • Coimbatore, India, 641 037
        • G. Kuppuswamy Naidu Memorial Hospital
      • Hyderabad, India, 500 082
        • Nizam's Institute of Medical Sciences
      • Mumbai, India, 400012
        • Tata Memorial Hospital
      • New Delhi, India, 110029
        • All India Institute of Medical Sciences
      • Trivandrum, India, 695011
        • Regional Cancer Center
      • Vellore, India, 632002
        • Christian Medical College and Hospital
  • Indonesia
      • Jakarta, Indonesia, 11420
        • Dharmais Cancer Hospital
      • Jakarta, Indonesia
        • Cipto Mangunkusumo General Hospital
      • Yogyakarta, Indonesia, 55284
        • Rumah Sakit RSUP Dr. Sardjito
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Severance Hospital
    • Gyeonggi-do
      • Anyang-si, Gyeonggi-do, Korea, Republic of
        • Hallym University Sacred Heart Hospital
  • Malaysia
      • Kuala Lumpur, Malaysia, 50586
        • Hospital Kuala Lumpur
      • Kuala Lumpur, Malaysia, 59100
        • University of Malaysia Medical Center
      • Kuala Lumpur, Malaysia
        • University Kebangsaan Malaysia Medical Center
    • Sarawak
      • Kuching, Sarawak, Malaysia
        • Sarawak General Hospital
  • New Zealand
      • Christchurch, New Zealand, 8140
        • Christchurch Public Hospital
      • Dunedin, New Zealand
        • Dunedin Hospital
  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11525
        • King Fahad Medical City
  • Singapore
      • Singapore, Singapore
        • Tan Tock Seng Hospital
      • Singapore, Singapore, 169610
        • National Cancer Centre - Singapore
      • Singapore, Singapore
        • Johns Hopkins Singapore International Medical Center
  • Sri Lanka
      • Maharagama, Sri Lanka
        • National Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • 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
  • Written informed consent

Exclusion Criteria

  • 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)
  • Patient on other investigational drug
  • Patients with HNPCC (Lynch Syndrome)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: acetylsalicylic acid
200mg OD for 3 years
Drug: Acetylsalicylic acid
Adjuvant Therapy
Other Names:
  • Aspirin
Placebo Comparator: Placebo
200mg OD for 3 years
Other: placebo
Placebo Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival
Time Frame: 5 years
Recurrence data documented
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 5 years
Death data documented
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Centre, Singapore

Collaborators

University of Sydney
Australasian Gastro-Intestinal Trials Group
INDOX Cancer Research Network

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2008

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

November 29, 2007

First Submitted That Met QC Criteria

November 29, 2007

First Posted (Estimated)

November 30, 2007

Study Record Updates

Last Update Posted (Estimated)

February 2, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000577892
  • SINGAPORE-ICR-02 (Other Identifier: SCRI)
  • SINGAPORE-ASCOLT (Other Identifier: SCRI)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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