Phase II trial of S-1+oxaliplatin+Cetuximab as first-line treatment in patients with kras-wild type unresectable advanced colorectal cancer - KODK 9 -

Phase II trial of S-1+oxaliplatin+Cetuximab as first-line treatment in patients with kras-wild type unresectable advanced colorectal cancer - KODK 9 - - KODK 9

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008963

Enrollment

Registered

2012-09-25

Start date

2011-08-31

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

(SOX+Cmab) L-OHP 85mg/m2 i.v.(day1) Cmab 500mg/m2 i.v.(day1) S-1 80mg/m2(day1-7) to be repeated every 2 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histopathology confirmed colorectal cancer. 2. KRAS wild-type is confirmed. 3. Presence of at least one measurable lesion (according to the RECIST v1.1) 4.ECOG performance status of 0-1. 5.No prior chemotherapy for colorectal cancer 6.Required baseline laboratory parameters (within 14 days before registration): WBC >= 4,000/mm3 Neu >= 2,000/ mm3 Plt >= 100,000/ mm3 Hb >= 9.0g/dl GOT,GPT<= 100U/L T-Bil <= 1.5mg/dl Cre <1.2mg/dl Ccr >= 60mL/min 7.Age: 20-80 years 8. Written informed consent 9.Be able to take oral drugs

Exclusion criteria

Exclusion criteria: 1.Severe complications 2.History of severe allergy 3.Peripheral sensory 4.Chickenpox 5.Receiving flucytosine 6.Serious infusion reaction has revealed 7. A case with an acute inflammatory disorder 8. Pregnant or lactating women or women of childbearing potential, and no birth-control 9. Active other malignancies. 10. Brain metastasis 11. Atopic dermatitis 12. Not appropriate for the study at the physician's assessment

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Progression Free Survival,Adverse events,Overall Survival,Relative Dose Intensity	—

Countries

Japan

Contacts

Public ContactTsuyosi Okabayashi

Keio University School of Medicine Department of Surgery

okabayashikoji@gmail.com03-3353-2681

Outcome results

None listed

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