NIPH Clinical Trials Search

UMIN ID: UMIN000001342

Registered date:29/08/2008

Phase II study of combination therapy with Irinotecan and S-1 in patients with progressive colorectal cancer after FOLFOX regimen

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedUnresectable advanced/recurrent colorectal cancer
Date of first enrollment2007/08/03
Target sample size56
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Irinotecan+S-1, repeated every 3 weeks.


Primary OutcomeRR
Secondary OutcomeSafety, PFS, 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. Active concomitant malignancy 5. Active infections 6. High blood pressure and diabetic that cannot be controlled 7. symptomatic or asymptomatic but treated heart disease 8. interstitial pnumonitis, pulmonary fibrosis or high-grade pulmonary emphysema 9. histry of mental disturbances or cerebrovascular attach 10. Fresh hemorrhage from digestive tube, intestines tube paralysis, intestinal obstruction and peptic ulcer 11. Plerral effusion, peritoneal fluid and pericardial fluid 12. Symptomatic brain metastasis 13. Water solubility diarrhea, in case of the patient who has a colostomy, diarrhea impairs daily life activity 14. Need to treatment with atazanavir sulfate or flucytosine 15. under coutinuous steroid therapy 16. Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers 17. on other clinical trial 18. Other conditions not suitable for this study

Related Information


public contact
Address Maidashi 3-1-1, Higashi-ku, Fukuoka, 812-8582 Japan
Telephone 092-631-2920
Affiliation CReS KSCC
scientific contact
Name Maehara Yoshihiko
Address Maidashi 3-1-1, Higashi-ku, Fukuoka, 812-8582 Japan
Telephone 092-631-2920
Affiliation Kyushu University Dpt. of surgery and science