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Multicenter phase II study of combination chemotherapy with IRIS and Cetuximab as second line therapy in patient with colorectal cancer

Multicenter phase II study of combination chemotherapy with IRIS and Cetuximab as second line therapy in patient with colorectal cancer - Multicenter phase II study of combination chemotherapy with IRIS and Cetuximab as second line therapy in patient with colorectal cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000006793
Enrollment
40
Registered
2011-12-01
Start date
2011-12-01
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

colorectal cancer

Interventions

S-1 : day1-14 80mg/m2. CPT-11 : day1 150mg/m2 Cetuximab : day1,8,15 400mg/m2 (1st time) , 250mg/m2 (2nd time or another) to be repeated every 3 weeks

Sponsors

Nippon Medical School Musashikosugi Hospital
Lead Sponsor
Nippon Medical School Hospital Nippon Medical School Tama Nagayama Hospital Nippon Medical School Chiba Hokusoh Hospital
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Histologically confirmed colorectal cancer 2) Unresectable advanced/recurrent colorectal cancer 3) Age between 20 to 80 years 4) ECOG performance status 0-1 5) Presence of measurable lesion (RECIST) 6) Prior chemotherapy involving L-OHP 7) No prior chemotherapy involving CPT-11 or Cetuximab 8) Sufficient organ functions 9) The case can eat 10) Written informed consent

Exclusion criteria

Exclusion criteria: 1) History of severe allergy 2) Simultaneous or metachronous double cancers 3) active infectious disease, 4) Severe comorbidity 5) Massive pleural effusion or ascites 6) Wattery diarrhea 7) Paralytic or mechanical bowel obstruction 8) Symptomatic brain metastasis 9) Patients who is receiving Fluorocytosine or Atazanavir Sulfate 10) Pregnant or lactating women or women of childbearing potential. 11) Amalgamation of mental disease or psychotic manifestation 12) Patients who are inadequate by investigator's decision.

Design outcomes

Primary

MeasureTime frame
response rate

Secondary

MeasureTime frame
progression free survival overall survival disease control rate re-resection rate adverse event dose intensity

Countries

Japan

Contacts

Public ContactHideyuki Suzuki

Nippon Medical School Musashikosugi Hospital Institute of Gastroenterology

044-733-5181

Outcome results

None listed

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