Multicenter Phase II study of combination therapy with S-1 plus Irinotecan plus Cetuximab (MetronomicIRIS/Cmab combination therapy) in patients with KRAS wild type unresectable colorectal cancer, who had previously received on fluoropyrimidine , oxaliplatin , irinotecan and bevacizumab. (KSCOG CR-06)

Multicenter Phase II study of combination therapy with S-1 plus Irinotecan plus Cetuximab (MetronomicIRIS/Cmab combination therapy) in patients with KRAS wild type unresectable colorectal cancer, who had previously received on fluoropyrimidine , oxaliplatin , irinotecan and bevacizumab. (KSCOG CR-06) - Multicenter Phase II study of MetronomicIRIS/Cmab combination therapy in patients with KRAS wild type unreseactable colorectal cancer. (KSCOG CR-06)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012063

Enrollment

Registered

2013-10-18

Start date

2013-11-01

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

MetronomicIRIS(S-1/CPT-11)/Cmab combination therapy S-1:50 or 60 or 80mg/body/day(day3-7,10-14,17-21,24-28) CPT-11:60mg/m2(day1,8,15) Cmab*:250mg/m2(day1,8,15,22) *:400mg/m2 for the initial dosi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with histologically proven colorectal cancer 2) KRAS wild type 3) Age 20 years<= 80 4) Patients who had previously received on fluoropyrimidine, oxaliplatin, irinotecan and bevacizumab 5) ECOG performance status 0-2 6) Presence of measurable lesion judged by enhanced CT (according to the RECIST) 7) Patiens have enough organ function based on blood test within 28day before registration 1.WBC>=3,000/mm3<=12,000/mm3 2.Neurtophils>=1,500/mm3 3.Platelets>=100,000/mm3 4.Hemoglobin>=9.0g/dl 5.Total bilirubin<=2.0mg/dl 6.AST and ALT<=100U/L(ALT<=200U/L with liver metastases) 7.Serum creatinine <=1.5 mg/dl 8.creatinine clearance>=50ml/min 8) Be able to take oral drugs 9) Life expectancy at least 3 months 10) Written informed consent

Exclusion criteria

Exclusion criteria: 1) With contraindicate S-1 2) Patients under treatment with flucytosine,phenytoin,warfarin potassium 3) Patients who is receiving Atazanavir Sulfate 4) Severe bone marrow suppression 5) Active infection and inflammation 6) Comorbidity or history of interstitial lung disease or pulmonary fibrosis 7) Massive pleural effusion or ascites 8) Watery stools or diarrhea 9) Severe complications 10) Simultaneous or metachronous double cancers 11) Pregnant or lactating women or women of childbearing potential 12) Other patients who are unfit for the study as determined by the attending physician

Design outcomes

Primary

Measure	Time frame
Progression free survival	—

Secondary

Measure	Time frame
Overall response rate Disease control rate Overall survival Safety Dose intensity	—

Countries

Japan

Contacts

Public ContactYutaka Ogata

Kurume University Medical Center Department of Surgery

yogata@med.kurume-u.ac.jp0942-22-6111

Outcome results

None listed

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