Safety and efficacy of Alternating mFOLFOX6 plus bevacizumab and FOLFIRI plus bevacizumab every 4cycles as First line Therapy in Advanced colorectal Cancer

UMIN ID: UMIN000001312

Registered date:12/08/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Unresectable advanced/recurrent colorectal cancer
• Date of first enrollment: 2008/03/01
• Target sample size: 51
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Alternating mFOLFOX6 plus bevacizumab and FOLFIRI plus bevacizumab every 4cycles.

Outcome(s)

• Primary Outcome: PFS
• Secondary Outcome: Response rate, Safety, OS

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1. Administering antithrobotic drug within 7 days 2. Serious complications (renal failure or hepatic failure) 3. Serious drug hypersensitivity or a history of drug allergy 4. Peripheral neuropathy 5. Active concomitant malignancy 6. Active infections 7. High blood pressure and diabetic that cannot be controlled 8. symptomatic or asymptomatic but treated heart disease 9. interstitial pnumonitis, pulmonary fibrosis or high-grade pulmonary emphysema 10. histry of mental disturbances or cerebrovascular attach 11. Fresh hemorrhage from digestive tube, intestines tube paralysis, intestinal obstruction and peptic ulcer 12. Current or previous (within one year) history of GI perforation 13. Plerral effusion, peritoneal fluid and pericardial fluid 14. Symptomatic brain metastasis 15. Water solubility diarrhea, in case of the patient who has a colostomy, diarrhea impairs daily life activity 16. Need to treatment with atazanavir sulfate 17. under coutinuous steroid therapy 18. Any surgical treatments including skin-open biopsy, trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week 19. CV-port procedure within one week 20. Anti-platelets therapy (including aspirin and NSAIDS) 21. history of organ transplantation 22. Traumatic gracture of unrecovery 23. Bevacizumab used previous chemotherapy 24. Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers 25. Other conditions not suitable for this study

Related Information

• Primary Sponsor: KSCC
• Source(s) of Monetary Support: CReS