Adjuvant Low Dose Aspirin in Colorectal Cancer

Korábbi kezelés

• Concomitant antiplatelet therapy (eg clopidrogrel or ticlopidine) or anticoagulant therapy (warfarin or low molecular weight heparin). Post-operative treatment with low molecular weight heparin must be withdrawn before administration of study treatment
• Active gastritis or peptic ulcer, or significant surgical post-op bleeding, within the previous three months assessed at screening and randomization
• Ongoing regular use of corticosteroids, Nonsteroidal Anti-Inflammatory Drug (NSAID)

Más betegség

• Hereditary colorectal cancer linked to familial colonic polyposis or Lynch syndrome
• Inflammatory bowel disease (Crohn's disease or ulcerative colitis)
• Other cancers (excluding colorectal cancer or other skin cancer than melanoma) within 3 years from screening
• Known bleeding diathesis (such as hemophilia)
• Uncontrolled hypertension according to Investigator's judgment
• Clinically significant liver impairment according to Investigators judgment
• Significant medical illness that would interfere with study participation
• Known allergy to NSAIDs or ASA

Laborértékek

• Existing renal failure according to Investigator's judgment. Renal failure with decreased creatinine clearance <60 should lead to consultation with a nephrologist.

Egyéb

• Distant metastases
• Pregnancy or breastfeeding females
• Current participation in another clinical trial that will be in conflict with the present study
• Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude, inability to return for subsequent visits) and/or otherwise considered by the Investigator to be unlikely to complete the study

• Tumor with somatic alterations in PIK3CA, PIK3R1 or PTEN
• Colon or rectal cancer tumor stage II-III
• Radical surgery according to surgeon and pathologist
• Karnofsky performance status ≥60%
• Platelets ≥ 100 x 109 / L
• Clean Colonoscopy or Computed Tomography (CT) colon within 3 months preoperatively or postoperatively but before randomization
• Patient able to swallow tablets
• Patient able to understand and sign written informed consent