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

UMIN ID: UMIN000001340

Registered date:29/08/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Unresectable advanced/recurrent colorectal cancer
• Date of first enrollment: 2007/07/01
• Target sample size: 47
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Alternating mFOLFOX6 and FOLFIRI every 4cycles.

Outcome(s)

• Primary Outcome: RR
• Secondary Outcome: Safety, PFS, 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. Plerral effusion, peritoneal fluid and pericardial fluid 13. Symptomatic brain metastasis 14. Water solubility diarrhea, in case of the patient who has a colostomy, diarrhea impairs daily life activity 15. Need to treatment with atazanavir sulfate 16. under coutinuous steroid therapy 17. Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers 18. on other clinical trial 19. Other conditions not suitable for this study

Related Information

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