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

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000441

Enrollment

2660

Registered

2010-05-17

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Aspirin: 200 mg OD for 3 years Control Intervention1: Placebo: 200 mg OD for 3 years

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
1. Disease free survival for all eligible subjects (high risk Dukes B colon cancer, Dukes C colon cancer and rectal cancer ptient sub groups)Timepoint: 3 years;Disease free survival for colon cancer (high risk Dukes B and Dukes C colon cancer)Timepoint: 3 years	—

Secondary

Measure	Time frame
Overall survival over 5 yearsTimepoint: 5 years	—

Countries

China, Hong Kong, India, Indonesia, Malaysia, Philippines, Saudi Arabia, Singapore, Taiwan, Thailand

Contacts

Public ContactDr. Atul Sharma

atul1@hotmail.com01126589490

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026