Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers

  • participants needed
  • sponsor
    National Cancer Centre, Singapore
Updated on 7 November 2020
Nick Pavlakis
Primary Contact
Northern Cancer Institute, St Leonards (4.8 mi away) Contact
+42 other location
colon cancer
rectal carcinoma


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)


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

Treatment Placebo, Acetylsalicylic acid
Clinical Study IdentifierNCT00565708
SponsorNational Cancer Centre, Singapore
Last Modified on7 November 2020

Adding a note
adding personal notes guide

Select a piece of text and start making personal notes.


Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Colorectal Cancer?
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)
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Phone Email

Please verify that you are not a bot.
Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more
Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more
Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer


user name

Annotated by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No made yet