A randomized Phase II study comparing SOX+B-mab with SOX+C-mab in patients with previously untreated recurrent advanced colorectal cancer with KRAS wild type.

A randomized Phase II study comparing SOX+B-mab with SOX+C-mab in patients with previously untreated recurrent advanced colorectal cancer with KRAS wild type. - A randomized Phase II study comparing SOX+B-mab with SOX+C-mab in patients with previously untreated recurrent advanced colorectal cancer with KRAS wild type. (SOX+BC)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006706

Enrollment

Registered

2011-11-11

Start date

2011-11-10

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

previously untreated recurrent advanced colorectal cancer with KRAS wild type

Interventions

A group (SOX+B-mab) TS-1 administered for 14 days followed by 7 days rest according to body surface area. L-OHP is administered intravenously in 130 mg/m2 at day 1. B-mab is administered intravenou

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histopathological confirmation of Adenocarcinoma. 2.Untreated recurrent or advanced colorectal cancer. 3.KRAS wild type 4.Measurable disease 5.Age 20=< 6.ECOG performance status of 0 to 1 7.No prior chemotherapy 8.At least one measurable lesion based on the recist criterion. (within 30 days before registration) 9.Sufficient function of important organs Leu : >=4,000 /mm3 Neu : >= 2,000 /mm3 Plt : >= 100,000 /mm3 hemoglobin : >= 9.0 g/dL AST, ALT : =< 2.5xULN IU/L (5.0xULN IU/L in case of liver metastasis) St.bil : =< 1.5 mg/dL Ccr : >= 40 ml/min proteinuria : =<1+ INR : =<1.5 10.Expected more than 3 months survival 11.Sufficient oral intake 12.With written informed consent

Exclusion criteria

Exclusion criteria: 1.History of the severe hypersensitivity 2.Active infection and inflammation. 3.Severe complications 4.Case with the history of usage of the L-OHP 5.Patients under treatment with steroid 6.Patients under treatment with flucytosine, phenytoin or warfarin potassium 7.Symptomatic or asymptomatic but treated heart disease 8.Patients have peripheral sensory neuropathy 9.Watery stools or diarrhea 10.Patients have Active hepatitis type B 11.Massive pleural or abdominal effusion 12.Patients have gastrointestinal perforation or bleeding 13.High-grade stricture 14.High-grade peritoneal metastasis or node 15.Metastasis to CNS 16.synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ 17.Pregnant or lactating woman 18.No birth-control 19.Other patients who are unfit for the study as determined by the attending physician.

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Desease control rate, Progression-free survival, Overall survival, Time to treatment failure, Completion rate of treatment, R0 resection rate, Time to efficacy, Frequency and grade of adverse event	—

Countries

Japan

Contacts

Public ContactMamoru Uemura

Osaka University Graduate School of Medicine Department of Surgery

muemura@gesurg.med.osaka-u.ac.jp06-6879-3251

Outcome results

None listed

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