Phase II study of combination therapy with S-1 plus cetuximab in patients with EGFR positive KRAS wild type unresectable colorectal cancer, who had previously received on irinotecan, oxaliplatin and fluoropyrimidine(KSCC0901).

Phase II study of combination therapy with S-1 plus cetuximab in patients with EGFR positive KRAS wild type unresectable colorectal cancer, who had previously received on irinotecan, oxaliplatin and fluoropyrimidine(KSCC0901). - Phase II study of 3rd-line therapy with S-1 plus cetuximab in patients with KRAS wild type unresectable colorectal cancer(KSCC0901).

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002475

Enrollment

Registered

2009-09-11

Start date

2009-10-01

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

Cetuximab/S-1 combination therapy Cetuximab weekly administration 400 mg/m2(day1), 250mg/m2/week(except day1) S-1 80-120mg/day, PO from day1 to day 28 of each 42 day cycle.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Written informed consent 2) Patients who is judged by investigator to be able to receive the protocol therapy 3) Patients with histologically proven colorectal cancer and clinically proven unresectable advanced/recurrent colorectal cancer 4) Presence of measurable lesion judged by enhanced CT (according to the RECIST 1.1) 5) Patients who had previously received on irinotecan, oxaliplatin and fluoropyrimidine. 6) Patients who had documented PD of 5FU based chemotherapy. 7) EGFR expression in the primary or metastatic tumor tissue is confirmed by immunohistochemical evaluation regardless of intensity 8) KRAS wild type in codon 12 and 13 in the primary or metastatic tumor tissue is confirmed by KSCC central test. 9) Prior chemotherapy was done in the first study treatment before at least 2 weeks 10) Age 20 years<= 11) ECOG performance status 0-1 12) Life expectancy of 3 months 13) Patiens have enough organ function based on blood test within 1 week before registration. 1.WBC>=3,000/mm3 , 2.Neurtophils>=1,500/mm3 3. Platelets>=100,000/mm3 4. Hemoglobin>=9.0g/dl 5. Total bilirubin<=2.0mg/dl 6. AST<=upper limit of normal (ULN)*2.5 (<=ULN*5 in case of liver metastasis) 7.ALT<=upper limit of normal (ULN)*2.5 (<=ULN*5 in case of liver metastasis) 8. Creatinine<=1.5mg/dl 9. creatinine clearance>=50ml/min

Exclusion criteria

Exclusion criteria: 1) Severe bone marrow suppression 2) Severe infectious disease 3) Massive pleural effusion or ascites 4) Comorbidity or history of severe heart failure 5) Comorbidity or history of interstitial lung disease or pulmonary fibrosis 6) Paralytic or mechanical bowel obstruction 7) Jaundice 8)History of severe allergy 9)Impossible to evaluate disease by enhanced CT 10)Pregnant or lactating women or women of childbearing potential 11)Severe comorbidity (uncontrolable diabetes, hypertension, hypercarcemia etc) 12)Symptomatic brain metastasis 13)Simultaneous or metachronous double cancers 14)Patients who had received anti EGFR drug that include cetuximab. 15)Any other cases who are regarded as inadequate for study enrollment by the investigator.

Design outcomes

Primary

Measure	Time frame
Progression free survival(PFS)	—

Secondary

Measure	Time frame
ORR, OS, OS from first diagnosis, DCR, TTF, DI, safety, BRAF mutation	—

Countries

Japan

Contacts

Public ContactKSCC

Clinical Research Support Center Kyushu KSCC

kscc2@cres-kyushu.or.jp092-631-2920

Outcome results

None listed

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