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

Phase II study of combination therapy with Irinotecan and S-1 in patients with progressive colorectal cancer after FOLFOX regimen - Phase II study of combination therapy with Irinotecan and S-1 in patients with progressive colorectal cancer after FOLFOX regimen(KSCC0702)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001342
Enrollment
56
Registered
2008-08-29
Start date
2007-08-03
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unresectable advanced/recurrent colorectal cancer

Interventions

Sponsors

KSCC
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.colorectal cancer, cytologically and/or histrogically, and Unresectable advanced/recurrent colorectal cancer 2.2nd-line after FOLFOX base chemotherapy 3.the last prior therapy before more than 2 weeks of registration 4.no prior radiotherapy 5.age: 20-75 years old 6.Performance Status (ECOG): 0-2 7.with measurable lesions 8.Life expectancy estimated >= 3 months 9.Sufficient organ functions 10.witten informed consents

Exclusion criteria

Exclusion 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. 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

Design outcomes

Primary

MeasureTime frame
RR

Secondary

MeasureTime frame
Safety, PFS, OS

Countries

Japan

Contacts

Public ContactKSCC

CReS KSCC

kscc2@cres-kyushu.or.jp092-631-2920

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026