A multicenter phase I/II study of irinotecan (CPT-11) and S-1 combination chemotherapy for metastatic colorectal cancer (CRC)

A multicenter phase I/II study of irinotecan (CPT-11) and S-1 combination chemotherapy for metastatic colorectal cancer (CRC) - C-0401

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001617

Enrollment

Registered

2009-01-06

Start date

2004-02-01

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

advanced/recurrent colorectal cancer

Interventions

Irinotecan+S-1, repeated every 3 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.colorectal cancer, cytologically and/or histrogically, 2.Unresectable advanced/recurrent colorectal cancer 3. age: 20-75 years old 4. Performance Status (ECOG): 0,1 5. with measurable lesions 6.No prior chemotherapy / radiotherapy 7. the last prior therapy before more than 12 weeks of registration 8. Sufficient organ functions 9.witten informed consents

Exclusion criteria

Exclusion criteria: 1. Serious drug hypersensitivity or a history of drug allergy 2. Plerral effusion, peritoneal fluid and pericardial fluid 3.Active infections 4. Water solubility diarrhea, in case of the patient who has a colostomy, diarrhea impairs daily life activity 5.Intestines tube paralysis, intestinal obstruction and peptic ulcer 6. interstitial pnumonitis, pulmonary fibrosis 7.Need to treatment with flucytosine 8.Active concomitant malignancy 9.diabetic that cannot be controlled 10. symptomatic or asymptomatic but treated heart disease 11. histry of mental disturbances or cerebrovascular attach 12. under coutinuous steroid therapy 13. Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers 14.Other conditions not suitable for this study

Design outcomes

Primary

Measure	Time frame
Phase I : recommended dose Phase I I: Response rate	—

Countries

Japan

Outcome results

None listed

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