Preventive effect of shakuyaku-kanzo-to on neurotoxicity of FOLFOX plus bevacizumab for patients with metastatic colorectal cancer: a prospective phase II study
Phase 2
- Conditions
- Colorectal Cancer
- Registration Number
- JPRN-UMIN000001853
- Lead Sponsor
- niversity of Toyama
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method eurotoxicity frequency of accumulation dose 500mg/m2 of oxaliplatin
- Secondary Outcome Measures
Name Time Method Time to treatment failure Progression-free survival Response rate Adverse events Neurotoxicity incidence