Colorectal Cancer
Conditions
Interventions
Patients receive FOLFOX4 plus bevacizumab or modified FOLFOX6 plus bevacizumab and take shakuyaku-kanzo-to (7.5g/day) orally every day during FOLFOX plus bevacizumab treatment.
Sponsors
University of Toyama
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed adenocarcinoma of the colon and rectum 2. Unresectable or recurrent colorectal cancer 3. No prior chemotherapy, immunotherapy and radiotherapy 4. Age 20<= years 5. ECOG performance status of 0,1 6. Life expectancy at least 12 weeks 7. Adequate organ function 8. Sufficient oral intake 9. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Active other malignancies 2. Brain metastasis 3. Massive pleural effusion or ascites 4. History of severe drug hypersensitivity 5. Uncontrollable hepertension 6. Severe complications(ileus, interstitial pneumonitis, pulmonary fibrosis, uncontrollable diabetes mellitus, heart failure) 7. History of thromboembolitic disease 8. Bleeding diathesis 9. Active peptic ulcer 10. Active infectious disease 11. Uncontrollable watery diarrhea 12. Peripheral neuropathy 13. Aldosteronism 14. Myopathy 15. Surgical procedure within 4 weeks before registration 16. Psychosis 17. Pregnant or lactating woman 18. Not appropriate for the study at the physician's assessmnt
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neurotoxicity frequency of accumulation dose 500mg/m2 of oxaliplatin | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to treatment failure Progression-free survival Response rate Adverse events Neurotoxicity incidence | — |
Countries
Japan
Contacts
Public ContactAyumu Hosokawa
University of Toyama Department of Gastroenterology and Hematology, Faculty of Medicine
Outcome results
None listed