CAPRI 2 GOIM Study: Investigate the Efficacy and Safety of a Bio-marker Driven Cetuximab-based Treatment Regimen

Exclusion Criteria

• •1. Any contraindication to the use of cetuximab, Irinotecan, 5-FU, oxaliplatin, folinic acid,bevacizumab, trifluridine-tipiracil, regorafenib
• •2. Active uncontrolled infections, active disseminated intravascular coagulation or history of interstitial lung disease
• •3. Past or current history of malignancies other than colorectal carcinoma, except for curatively treated basal and squamous cell carcinoma of the skin cancer or in situ carcinoma of the cervix
• •4. Pregnancy (exclusion to be ascertained by a beta hCG test)
• •5. Breastfeeding
• •6. Fertile women (\<2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception•
• •7. Myocardial infarction, unstable angina pectoris, balloon angioplasty (PTCA) with or without stenting within the past 12 months before inclusion in the study, Grade III or IV heart failure (NYHA classification)
• •8. Cardiac arrhythmias requiring anti-arrhythmic therapy, with the exception of beta blockers or digoxin
• •9. Medical or psychological impairments associated with restricted ability to give consent or not allowing conduct of the study
• •10. Previous chemotherapy for the colorectal cancer with the exception of adjuvant treatment, completed at least 6 months before entering the study
• •11. Participation in a clinical study or experimental drug treatment within 30 days prior to study inclusion or during participation in the study
• •12. Known or clinically suspected brain metastases
• •13. History of acute or subacute intestinal occlusion or chronic inflammatory bowel disease or chronic diarrhoea
• •14. Severe, non-healing wounds, ulcers or bone fractures
• •15. Uncontrolled hypertension
• •16. Marked proteinuria (nephrotic syndrome)
• •17. Known DPD deficiency (specific screening not required)
• •18. Known history of alcohol or drug abuse
• •19. A significant concomitant disease which, in the investigating physician's opinion, rules out the patient's participation in the study
• •20. Absent or restricted legal capacity