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

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ClinicalTrials.gov Identifier: NCT00565708
Recruitment Status : Recruiting
First Posted : November 30, 2007
Last Update Posted : September 16, 2019
Sponsor:
Collaborators:
University of Oxford
Australasian Gastro-Intestinal Trials Group
INDOX Cancer Research Network
Information provided by (Responsible Party):
John Chia Whay Kuang, National Cancer Centre, Singapore

Tracking Information
First Submitted Date  ICMJE November 29, 2007
First Posted Date  ICMJE November 30, 2007
Last Update Posted Date September 16, 2019
Study Start Date  ICMJE December 2008
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2012)
Disease-free survival [ Time Frame: 5 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 29, 2007)
Disease-free survival at 3 years
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2012)
Overall survival [ Time Frame: 5 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2007)
  • Overall survival at 5 years
  • Disease-free survival of Chinese, Malay, Indian, and other ethnic groups
  • Disease-free survival of subgroups of patients with Dukes stage C or high-risk Dukes stage B colorectal cancer
  • Adverse events
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers
Official Title  ICMJE Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers - An International, Multi-Center, Double Blind, Randomized Placebo Controlled Phase III Trial
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)
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Other: placebo
    Placebo Comparator
  • Drug: Acetylsalicylic acid
    Adjuvant Therapy
    Other Name: Aspirin
Study Arms  ICMJE
  • Experimental: acetylsalicylic acid
    200mg OD for 3 years
    Intervention: Drug: Acetylsalicylic acid
  • Placebo Comparator: Placebo
    200mg OD for 3 years
    Intervention: Other: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 24, 2018)
1587
Original Enrollment  ICMJE
 (submitted: November 29, 2007)
1400
Estimated Study Completion Date  ICMJE June 2026
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: John Chia, MBBS, MRCP 65-96536990 nmocwk@nccs.com.sg
Contact: Estelle Foo, BN,CRP estelle.foo.m.j@nccs.com.sg
Listed Location Countries  ICMJE Australia,   China,   India,   Indonesia,   Korea, Republic of,   Malaysia,   New Zealand,   Philippines,   Saudi Arabia,   Singapore,   Sri Lanka,   Taiwan
Removed Location Countries Thailand
 
Administrative Information
NCT Number  ICMJE NCT00565708
Other Study ID Numbers  ICMJE CDR0000577892
SINGAPORE-ICR-02 ( Other Identifier: SCRI )
SINGAPORE-ASCOLT ( Other Identifier: SCRI )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party John Chia Whay Kuang, National Cancer Centre, Singapore
Study Sponsor  ICMJE National Cancer Centre, Singapore
Collaborators  ICMJE
  • University of Oxford
  • Australasian Gastro-Intestinal Trials Group
  • INDOX Cancer Research Network
Investigators  ICMJE
Study Chair: John Chia, MBBS, MRCP National Cancer Centre, Singapore
Study Chair: Raghib Ali, MBBS, MRCP University of Oxford
Study Chair: Han Chong Toh, MD, MBBS, MRCP National Cancer Centre, Singapore
Study Chair: Eva Segelov, MBBS,FRACP,PhD St. Vincent's Hospital-Manhattan
PRS Account National Cancer Centre, Singapore
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP