Phase II Study of bi-weekly SOX+Cetuximab for EGFR positive and K-ras wild type dvanced and recurrent Colorectal Cancer

Phase II Study of bi-weekly SOX+Cetuximab for EGFR positive and K-ras wild type dvanced and recurrent Colorectal Cancer - KW-SOXCet

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005884

Enrollment

Registered

2011-06-29

Start date

2010-09-01

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

Oxaliplatin:85mg/m2/week iv, day1.15 q 4weeks Cetuximab:day1 400, day8 250, day15 500mg/m2, day15- q 2weeks S-1:80mg/m2, day1-14 q 4weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histopathologically confirmed colorectal cancer. 2) EGFR positive, K-RAS wild-type, unresectable colorectal cancer. 3) Evaluable tumor lesions (RECIST ver.1.1). 4) ECOG Performance status (PS) of 0-1. 5) Colorectal cancer that is not amenable to curative resection and have non-previously received chemotherapy. 6) No severe organ failure: and suitable results of all laboratory test performed. White blood cell count >= 3,000/mm3 Neutrophil count >= 1,500/mm3 platelet count >= 75,000/mm3 hemoglobin >=8.0g/dl GOT,GPT: 100 U/L GOT and GPT <= 100. if the patient has liver metastasis <= 200. Total bilirubin <= 1.5mg/dL serum creatinine <= 1.2 mg/dL (CCr)60mL/min <= ECG: normal 7) Age of 20<=, <=75 years. 8 ) Written informed consent will be obtained from each patient before enrollment. 9) considered to survive for more than 3 months. 10) be able to take oral drugs

Exclusion criteria

Exclusion criteria: 1)Serious complications(intestinal paralysis and intestinal obstruction, interstitial pneumonia, pulmonary fibrosis, renal failure, cardiac failure , liver failure) 2)History of serious drug hypersensitivity 3)Peripheral neuropathy 4)without helpes simplex 5)Requiring flucytosine. 6)History of serious Infusional reaction. 7)Active infection. 8)renal dysfuncsion serum creatinine <= 1.2 mg/dL (CCr) 60mL/min <= 9)Pregnant or lactating woman 10)Active other malignancies. 11)Symptomatic brain metastasis 12)Atopic delmatitis 13)Not appropriate for the study at the physician's assessment

Design outcomes

Primary

Measure	Time frame
Response ratte : RR	—

Secondary

Measure	Time frame
Safety,Overall survival,Time to progression,Progression Free Survival ,Compliance	—

Countries

Japan

Contacts

Public ContactTadashi Anan

Jikei Medical University School of Medicine Gatrointestinal surgery

anan@jikei.ac.jp03-3433-1111

Outcome results

None listed

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