An exploratory study to evaluate biomarkers as predictive and /or prognostic factors of benefit from randomized phase ll study of mFOLFOX6+bevacizumab or mFOLFOX6+cetuximab in liver only metastasis from KRAS wild type colorectal cancer
Not Applicable
- Conditions
- liver only metastasis from KRAS Exon 2 wild type (under protocol 1.0-1.2 edition) and RAS wild type (under protocol 2.0 edition) colorectal cancer
- Registration Number
- JPRN-UMIN000010429
- Lead Sponsor
- EPS Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
None
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the values of angiogenesis-related growth factors in plasma with Progression-free survival (PFS); centrally assessed
- Secondary Outcome Measures
Name Time Method 1) To evaluate the correlation of values of angiogenesis-related growth factors in plasma with efficacy and adverse events - Response rate (RR) - Tumor shrinkage rate at week 8 - Liver resection rate - R0 liver resection rate (patholigically confirmed) - Progression-free survial (PFS); CT/MRI image assessed by the attending physician - Time to treatment-failure (TTF) - Overall survival (OS) - Incidence of adverse events (drag-related, surgery-related) - Exploratory endpoints - Primary endpoint and secondary endpoints in the RAS wild-type subpopulation 2) Exploratory analysis of the relevance of tumor size and expression level of angiogenesis-related growth factors in plasma