Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers

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Basic Trial Information

PhaseTypeAgeTrial IDs
Phase IIITreatment18 and overCDR0000577892
NCI-2015-01484, NCI-2014-01372, SINGAPORE-07-32-LGI, SINGAPORE-ASCOLT, SINGAPORE-ICR-02, ICR-02, NCT00565708

Trial Description



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.


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)

Further Study Information

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


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

Eligibility Criteria

Inclusion Criteria:

Male or female outpatient of ≥ 18 years of age or ≥ country's legal age for adult


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 ±


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


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)

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

National Cancer Centre

  • Australasian Gastro-Intestinal Trials Group Coordinating Center
  • INDOX Cancer Research Network
  • University of Oxford

Link to the current record.
NLM Identifer NCT00565708

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