Study of Cetuximab + Irinotecan + S-1 as first line therapy in metastatic colorectal cancer with KRAS wild type

Study of Cetuximab + Irinotecan + S-1 as first line therapy in metastatic colorectal cancer with KRAS wild type - CIRIS study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004580

Enrollment

Registered

2010-11-18

Start date

2010-11-01

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

Metastatic colorectal cancer

Interventions

IRIS + Cetuximab Cetuximab loading dose 400mg/m2, 250 mg/m2/week Irinotecan 100 mg/m2/biweekly S-1 80,100,120 mg/twice/day 1-14, following two weeks off

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with histologically proven colorectal cancer 2. Metastatic colorectal cancer 3. KRAS wild type 4. No prior chemotherapy for metastatic colorectal cancer 5. Age over 20 6. ECOG Performance Status 0-1 7. A measurable lesion is confirmed with objective documents such as CT, MRI and the X-ray check within 30th before registration. 8. Patients have enough organ function for study treatment. 9. Enable to internal use 10. Life expectancy of more than 3 months 11. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Sever myeloablation 2. Severe infectious disease 3. Sensory alteration or paresthesia interfering with function 4. A mental disorder, nucleus neuropathy, cerebrovascular neuropathy failure 5. Comorbidity or history of heart failure 6. Interstitial lung disease or pulmonary fibrosis 7. Prior radiotherapy for primary and metastases tumors 8. History of severe allergy 9. Women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test 10. Sever comorbidity (renal failure, liver failure, hypertension, high calcium, etc) 11. Symptomatic brain metastases 12. Patient have metachronous multiple malignancy 13. Any other cases who are regarded as inadequate for study enrollmet by investigators

Design outcomes

Primary

Measure	Time frame
Response Rate	—

Secondary

Measure	Time frame
Overall Survival Progression Free Survival Safety Best response: % change at baseline	—

Countries

Japan

Contacts

Public ContactToshiki Masuishi

Tsuchiura kyodo general hospital Department of Gastroenterology

Outcome results

None listed

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