Phase III, Multi-centre, Double Blind, Randomized Placebo Controlled Trial of Aspirin for Duke C and High Risk Dukes B Colorectal Cancers

Phase 3

• Conditions: Health Condition 1: null- Dukes C and High Risk Dukes B Colorectal Cancer

• Registration Number: CTRI/2010/091/000441
• Lead Sponsor: ational Cancer Centre Department of Medical Oncology Singapore

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 2660

Inclusion Criteria

1. Male or female outpatient of >= 18 years of age
2. Dukes C colon cancer, high risk Dukes B colon cancer, Dukes B rectal cancer or Dukes C rectal cancer
3. Undergone complete resection of primary tumor
4. Completed standard therapy (atleast 3 months of chemotharapy +- radiotherapy
5. Within 90 days of completion of standard therapy (syrgery, chemotherapy +- radiotherapy)
6. ECOG performance status 0-2
7. Satisfactory haematological or biochemical functions (tests should be carried out wuthin 2 weeks prior to randomization)
8. Creatinine clearence > 50 ml/min
9. Total bilirubin <= 1.5 x upper limit normal
10. AST/ALT <= 3 x the upper limit nirmal

Exclusion Criteria

1. Familial adenomatous polyposis, inflammatory bowel disease or ulcerative colitis
2. Active gastritis or active ulcer
3. History of continuous daily use of PPI more than 1 year prior to consent
4. Gastrointestinal bleeding within the past one year
5. Haemorrhagic diathesis (i.e haemophilia)
6. Uncontrolled hypertension (untreated SBP > 160 mm hg, or DBP >95 mm hg
7. History of recent cancers (except for non melanoma skin cancers, basal cell carcinomas, squamous cell carcinomas) in the past 5 years
8. History of stroke, CAD, angina, or vascular disease
9. Patients who are on current long term treatment (>= 4 consecutive weeks) with Aspirin, NSAID or Cox-2 inhibitor
10. History of erosive GERD or active erosive GERD on gastroscopy
11. Patient on antiplatelet agents (i.e off-study Aspirin, clopidogrel, ticlopidine)
12. Patient receiving anticoagulants (i.e warfarin, low molecular weight heparins)
13. Pregnant, lactating, or not using adequate contraception
14. Patient having known allergy to NSAID or Aspirin
15. Unexplained rise of CEA (i.e smoker with elevated CEA will not be excluded)
16. Patient on other investigational drug

Study & Design

• Study Type: Interventional
• Study Design: Not specified