Colorectal Cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed colorectal cancer. 2. No prior chemotherapy for metastatic disease. 3. Measurable lesion based on RECIST ver1.1. 4. Written informed consent 5. Age of at least 20 years. 6. ECOG PS of 0 or 1 7. A life expectancy of more than 3 months. 8. Adequate function of vital organs, including normal hematopoietic, liver and renal function: White blood cell count >= 3,000/mm3 and <= 12,000/mm3. Platelets>=100,000/mm3. Hemoglobin> =9.0g/dl Total bilirbin> =2.0mg/dl Aspartate aminotransferase and alanine aminotransferase levels <=100IU/I (200IU/I in case of liver metastasis) Serum creatinine level male:less than 1.8mg/dl female: less than 1.35mg/dl Urinary protein less than 1+
Exclusion criteria
Exclusion criteria: 1. Serious renal dysfunction 2. Serious drug hypersensitivity or a history of drug allergy 3. Active multiple primary neoplasm 4. Active infections 5. Serious heart disease 6. History of thrombosis, interstitial pneumonitis, pulmonary fibrosis or high-grade pulmonary emphysema 7. Fresh gastrointestinal hemorrhage, intestinal obstruction or peptic ulcer 8. Pleural effusion, peritoneal fluid and pericardial fluid 9. Symptomatic brain metastasis 10. History of mental disturbances or cerebrovascular disorder 11. Uncontrolled high blood pressure and diabetes 12. Uncontrolled diarrhea 13. Serious non-healing wound and/or major surgical procedure within 4 weeks prior to enrollment 14. Traumatic fracture not healed 15. Bleeding tendency and anti-platelets therapy (including aspirin and NSAIDS) 16. Pregnant or possibly pregnant, and nursing women 17. Peripheral neuropathy 18. Other conditions not suitable for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate Overall survival Time to treatment failure Relative dose intensity Safety | — |
Countries
Japan
Contacts
Epidemiological and Clinical research Information Network (ECRIN) Data Center