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.
- Conditions
- previously untreated recurrent advanced colorectal cancer with KRAS wild type
- Registration Number
- JPRN-UMIN000006706
- Lead Sponsor
- Multicenter Study Group of Osaka (MCSGO), Colorectal Cancer Treatment Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 50
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate
- Secondary Outcome Measures
Name Time Method 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