Efficacy of aspirin for stage III colorectal cancer: a randomized double-blind placebo-controlled trial (JCOG1503C, EPISODE III)
Phase 3
Recruiting
- Conditions
- Stage III colorectal cancer
- Registration Number
- JPRN-UMIN000031532
- Lead Sponsor
- Japan Clinical Oncology Group (JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 880
Inclusion Criteria
Not provided
Exclusion Criteria
1) Synchronous or metachronous (within 5 years) malignancies 2) Infections which needs systemic treatment. 3) Body temperature is higher than 38 degrees centigrade at registration. 4) History of allergy aspirin or salicylic acid. 5) Female during pregnancy, within 28 days of postparturition, or during lactation. 6) Severe psychological disease. 7) Continuous systemic corticosteroid or immunosuppressant treatment. 8) Severe postoperative complicatoins which do not resolve until registration. 9) Regularly using phenytoin. 10) Uncontrollable diabetes mellitus. 11) Uncontrollable hypertension. 12) Unstable angina pectoris, or history of myocardial infarction within 6 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease-free survival
- Secondary Outcome Measures
Name Time Method Overall survival, Relapse-free survival, Relative dose intensity, Adverse events, Sever adverse events.