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

Phase 3
18 Years
Open (Enrolling)
Colorectal Cancer

Thank you

Trial Information

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

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 oxalaplatin

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

Inclusion Criteria

Inclusion Criteria

- Male or female outpatient of 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

- Undergone complete resection of primary tumour

- Completed standard therapy (at least 3 months of chemotherapy +- radiotherapy)

- Within 90 days of completion of standard therapy (Surgery, Chemotherapy +-

- ECOG performance status 0-2

- Satisfactory Haematological or biochemical functions (tests should be carried out
within 4 weeks prior to randomization): Results of clinical investigations carried
out within 4 weeks prior to randomization 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 10^9/L

- Platelet count ≥ 100 x 10^9/L

- Creatinine clearance > 50 mL/min

- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST/ALT ≤ 3 times ULN

- Written Informed Consent

Exclusion Criteria

- Familial adenomatour polyposis, inflammatory bowel disease or ulcerative colitis

- Active gastritis or peptic ulcer

- History of continuous daily use of PPI more than 1 year prior to consent

- Gastrointestinal bleeding within the past year

- Hemorrhagic diathesis (i.e., hemophilia)

- 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

- People who are on current long term treatment with Aspirin, NSAID or Cox-2 inhibitors

- History of erosive GERD or active erosive GERD on gastroscopy

- Patient on antiplatelet agents

- Patient receiving anticoagulants

- Pregnant, lactating, or not using adequate contraception

- Known allergy to NSAIDs or aspirin

- Unexplained rise in CEA (i.e., smoker with elevated CEA will not be excluded)

- Patient on other investigational drug

- Patients with HNPCC (Lynch Syndrome)

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Disease-free survival

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

John Chia, MBBS, MRCP

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Centre, Singapore


Singapore: Health Sciences Authority

Study ID:




Start Date:

December 2008

Completion Date:

December 2020

Related Keywords:

  • Colorectal Cancer
  • stage II colon cancer
  • stage III colon cancer
  • stage II rectal cancer
  • stage III rectal cancer
  • Colorectal Neoplasms