Metastatic colorectal cancer Cancer Malignant neoplasm of other and ill-defined digestive organs
Conditions
Interventions
Non-interventional, observational study.
Patients with metastatic colorectal cancer are treated with standard chemotherapy in combination with bevacizumab as per SmPC. During the treatment adverse e
Sponsors
Institute Of Oncology Ljubljana (Slovenia)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent (for prospective part of the study) 2. Histologically or cytologically confirmed colorectal carcinoma with evidence of metastasis 3. Age 18 - 75 years 4. Eastern Cooperative Oncology Group (ECOG) performance score 0 - 2 5. Adequate haematological and organ function
Exclusion criteria
Exclusion criteria: 1. Clinical evidence of brain metastases 2. Clinically significant cardiovascular disease. Examples: 2.1. Cerebrovascular accident (CVA) less than or equal to 6 months before treatment start 2.2. Myocardial infarction less than or equal to 6 months before treatment start 2.3. Unstable angina 2.4. New York Heart Association (NYHA) greater than or equal to grade 2 chronic heart failure (CHF) 2.5. Arrhythmia requiring medication 2.6. Uncontrolled hypertension 3. Current or recent (within 10 days prior to first dose of bevacizumab) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic (as opposed to prophylactic) purposes 4. History of thromboembolic or haemorrhagic events within 6 months prior to treatment 5. Evidence of bleeding diathesis or coagulopathy 6. Serious, non-healing wound, ulcer, or bone fracture 7. Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to treatment 8. Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of bevacizumab or puts the patient at high risk for treatment-related complications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Safety of treatment with bevacizumab 2. Response rate: Response Evaluation Criteria in Solid Tumors (RECIST) 3. Rate of radical surgical resection (R0 resection) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Progression- free survival (PFS) 2. Overall survival (OS) | — |
Countries
Slovenia
Outcome results
None listed