Phase I/II study of triweekly administration regimen of irinotecan and TS-1 in patients with advanced colorectal cancer

Phase I/II study of triweekly administration regimen of irinotecan and TS-1 in patients with advanced colorectal cancer - Phase I/II study of irinotecan and TS-1 in patients with advanced colorectal cancer

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001365

Enrollment

Registered

2008-09-10

Start date

2004-12-01

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 colorectal cancer

Interventions

Treatment : TS-1+CPT-11

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Histological confirmation of colorectal cancer (2) Advanced colorectal cancer (3) Measurable disease (4) No prior chemotherapy/radiotherapy (5) ECOG-PS:0-2 (6) Adequate major organ function (7) All patients provided written informed consent

Exclusion criteria

Exclusion criteria: (1) Massive pleural effusion or massive ascites (2) Symptomatic brain metastases (3) Active diarrhea

Design outcomes

Primary

Measure	Time frame
1) Phase I To determine the recommended dose 2) Phase II Response Rate	—

Secondary

Measure	Time frame
Safety, Overall survival, Progression free survival	—

Countries

Japan

Contacts

Public ContactHitoshi Kusaba

Kyushu University Hospital Division of Hematology and Oncology

092-642-5232

Outcome results

None listed

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