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

ational Cancer Centre Department of Medical Oncology Singapore0 个研究点目标入组 2,660 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•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

•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

发起方

ational Cancer Centre Department of Medical Oncology Singapore