Preventive effect of shakuyaku-kanzo-to on neurotoxicity of FOLFOX plus bevacizumab for patients with metastatic colorectal cancer: a prospective phase II study

UMIN ID: UMIN000001853

Registered date:06/04/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Colorectal Cancer
• Date of first enrollment: 2009/04/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: Neurotoxicity frequency of accumulation dose 500mg/m2 of oxaliplatin
• Secondary Outcome: Time to treatment failure Progression-free survival Response rate Adverse events Neurotoxicity incidence

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: University of Toyama
• Source(s) of Monetary Support: None