Colorectal Cancer
Conditions
Interventions
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
Sponsors
INDOX Cancer Research Network
National Cancer Centre, Singapore
Eligibility
Inclusion 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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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)] | — |
Countries
China,India,Indonesia,Malaysia,Philippines,Saudi Arabia,Singapore,Sri Lanka,Taiwan, Province of China
Contacts
Public ContactDr. Nadarajah Jeyakumaran
Consultant Clinical Oncologist
Outcome results
None listed