Evaluating the effectiveness of Aspirin in Colorectal Cancer patients in terms of disease free survival and overall survival.

• Register: SLCTR
• Last refreshed on: 1 April 2024
• Main ID: SLCTR/2014/011
• Date of registration: 2014-05-26
• Prospective Registration: Yes
• Primary sponsor: INDOX Cancer Research Network
• Public title: Evaluating the effectiveness of Aspirin in Colorectal Cancer patients in terms of disease free survival and overall survival.
• Scientific title: Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers, An International, Multi-centre, Double Blind, Randomized Placebo Controlled Phase III Trial
• Date of first enrolment: 2014-05-26
• Target sample size: 40-50 (2660 evaluable patients globally)
• Recruitment status: Recruiting
• URL: https://slctr.lk/trials/slctr-2014-011
• Study type: Interventional
• Study design: Randomized controlled trial
• Phase: Phase 3

Countries of recruitment

China,India,Indonesia,Malaysia,Philippines,Saudi Arabia,Singapore,Sri Lanka,Taiwan, Province of China

Contacts

• Name: Prof. Asita de Silva
• Affiliation: Director

• Name: Dr. Nadarajah Jeyakumaran
• Affiliation: Consultant Clinical Oncologist

Key inclusion & exclusion criteria

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

• 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 (Eastern Cooperative Oncology Group) 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

• Absolute neutrophil count (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)


Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Colorectal Cancer

Intervention(s)

An eligible subject will be randomised to the study in 1:1 ratio to either
- Aspirin arm: 200 mg Aspirin once a day for 3 years
- Placebo arm: 200 mg matching placebo once a day for 3 years.

After randomisation, patient will have 3 monthly assessments for 3 years (month 3 to month 36) followed by 6 monthly assessments for additional 2 years (month 42 to month 60). Assessments include Haematology, Biochemistry, Colonoscopy, CT Scan, X-ray, ECG).

Primary Outcome(s)

1.Disease free survival (DFS) among all eligible subjects (high risk Dukes B colon cancer, Dukes C colon cancer and rectal cancer patient sub-groups)
2.DFS among patients with colon cancer (high-risk Dukes B and Dukes C colon cancer)
[From randomization up to 5 years (3 monthly assessments for 3 years followed by 6 monthly assessments for additional 2 years)]

Secondary Outcome(s)

1. Overall survival (OS) over 5 years
2. 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 tumours (where samples are available)
[From randomization up to 5 years (3 monthly assessments for 3 years followed by 6 monthly assessments for additional 2 years)]

Source(s) of Monetary Support

INDOX Cancer Research Network, University of Oxford National Cancer Centre, Singapore

Secondary Sponsor(s)

National Cancer Centre, Singapore

Ethics review

Status: Approved
Approval date: 11/09/2013
Contact:

[e-mail]

Ethics Review Committee, Faculty of Medicine, University of Kelaniya

[phone]

[e-mail]