NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000001312

Registered date:12/08/2008

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedUnresectable advanced/recurrent colorectal cancer
Date of first enrollment2008/03/01
Target sample size51
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Alternating mFOLFOX6 plus bevacizumab and FOLFIRI plus bevacizumab every 4cycles.

Outcome(s)

Primary OutcomePFS
Secondary OutcomeResponse rate, Safety, OS

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteria
Exclude criteria1. 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

Contact

public contact
Name KSCC
Address Maidashi 3-1-1, Higashi-ku, Fukuoka, 812-8582 Japan
Telephone 092-631-2920
E-mail kscc2@cres-kyushu.or.jp
Affiliation CReS KSCC
scientific contact
Name Maehara Yoshihiko
Address Maidashi 3-1-1, Higashi-ku, Fukuoka, 812-8582 Japan
Telephone 092-631-2920
E-mail info2@cres-kyushu.or.jp
Affiliation Kyushu University Dpt. of surgery and science