Colorectal cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed adenocarcinoma of the colon and rectum 2. Unresectable or recurrent colorectal cancer 3. No prior chemotherapy 4. Previous adjuvant therapy of fluoropyrimidines is permitted if completed at least 6 months before registration. 5. ECOG performance status of 0,1 6. Life expectancy of longer than 3 months 7. Adequate organ function 8. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Brain metastasis 2. Massive pleural effusion or ascites 3. Active other malignancies 4. Nonhealing wound 5. Surgical procedure within 28 days before registration 6. Severe complications(bowel obstruction, symptomatic cardiovascular disease, interstitial pneumonitis, pulmonary fibrosis, uncontrollable hepertension, uncontrollable diabetes mellitus, active peptic ulcer, bleeding diathesis) 7. History of thromboembolitic disease 8. Uncontrollable diarrhea 9. Administration of corticosteroids 10. Administration of anticoagulants 11. Peripheral neuropathy 12. Active infectious disease 13. History of severe drug hypersensitivity 14. Psychosis 15. Pregnant or breast-feeding women 16. Men of wishing fertility 17. Not appropriate for the study at the physician's assessmnt
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival Overall survival Time to treatment failure | — |
Countries
Japan
Contacts
University of Toyama Department of Gastroenterology and Hematology, Faculty of Medicine