A multicenter phase II trial of TS-1+oxaliplatin+panitumumab as first-line treatment in patients with kras-wild type unresectable advanced colorectal liver metastasis.

A multicenter phase II trial of TS-1+oxaliplatin+panitumumab as first-line treatment in patients with kras-wild type unresectable advanced colorectal liver metastasis. - A multicenter phase II trial of TS-1+oxaliplatin+panitumumab as first-line treatment in patients with kras-wild type unresectable advanced colorectal liver metastasis.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007236

Enrollment

Registered

2012-02-07

Start date

2012-02-01

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

Dosing period: until progression disease Dose: TS-1 80mg/m2 (day1 to day15) Oxaliplatin 130mg/m2 (day1) panitumumab 6mg/kg (day1) every 3 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histopathological confirmation of Adenocarcinoma located in colon and rectosigmoid. 2) KRAS wild type (in codon 12, 13) confirmed, either in the primary tumor or in metastatic tumor lesion 3) Patient with unresectable synchronous or metachronous liver metastasis 4) Age of 20~80 5) ECOG performance status of 0 to 1 6) Presence of at least one measurable lesion according to RECIST 7) Patient without prior chemotherapy or radiation therapy 8) Sufficient function of important organs 1. WBC:>= 3,000 /mm3 2. Neu : >= 1,500 /mm3 3. Platelet : >= 100,000 /mm3 4. Hemoglobin : >= 9.0 g/dL 5. Sr.bil : <= 2.0 mg/dL 6. AST, ALT : <= 100IU/L 7. Serum creatinine : <= 1.2mg/dL 8. Ccr : >= 50 ml/min 9) Sufficient oral intake 10) Expected more than 3 months survival 11) With written informed consent

Exclusion criteria

Exclusion criteria: 1) History of severe allergy 2) Administration contraindication of oxaliplatin, panitumumab, TS-1, or 5FU 3) Severe infectious disease 4) Severe complications (interstitial lung disease or pulmonary fibrosis, , kidney failure, hepatic failure, uncontrolable diabetes, uncontrolable hypertension) 5) History of interstitial lung disease or pulmonary fibrosis 6) Severe heart failure or history of severe heart failure 7) Peripheral sensory 8) Wattery diarrhea 9) Massive pleural effusion or ascites 10) Gastrointestinal perforation or bleeding 11) Patient medicated with anticoagulant drugs (except for low-dose aspirin [less than 325mg/day]) 12) Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ 13) Pregnant or lactating women or women of childbearing potential, and no birth-control 14) Mechanical bowel obstruction 15) Active hepatitis type B 16) Any other cases who are regarded as inadequate for study enrollment by the investigator.

Design outcomes

Primary

Measure	Time frame
RR: response rate	—

Secondary

Measure	Time frame
OS: overall survival PFS: progression free survival treatment completion rate safety	—

Countries

Japan

Contacts

Public ContactTakeshi Nagasaka

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Department of Gastroenterological Surgery

takeshin@cc.okayama-u.ac.jp086-235-7257

Outcome results

None listed

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