Colorectal Cancer
Conditions
Brief summary
The main aim of the study is to check gene change in tumor tissues with an additional analysis of the data from PARADIGM Exploratory Study, which is conducted for people with advanced/recurrent colorectal cancer. In the PARADIGM Exploratory Study (NCT02394834), the drug being tested in this study is called Panitumumab and the main aim of this study is to check side effect from the study treatment (mFOLFOX6 + bevacizumab versus mFOLFOX6 + panitumumab therapy) and check if the study treatment improves symptoms of advanced/recurrent colorectal cancer.
Detailed description
This is a non-interventional study to do additional exploratory analysis of biomarkers from the PARADIGM Exploratory Study (NCT02394834), which is conducted for participants with advanced/recurrent colorectal cancer. 757 patients have enrolled in the PARADIGM Exploratory Study.
Interventions
DRUGmFOLFOX6 + panitumumab combination therapy
oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab oxaliplatin (OXA), levofolinate calcium (l-LV), panitumumab: intra-venous infusion 5-FU: bolus and continuous intra-venous infusion
DRUGmFOLFOX6 + bevacizumab combination therapy
oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, bevacizumab oxaliplatin (OXA), levofolinate calcium (l-LV), bevacizumab: intra-venous infusion 5-FU: bolus and continuous intra-venous infusion
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
1. Participants enrolled in the PARADIGM Exploratory Study (NCT02394834) who have consented to the secondary use of samples and genomic data and have not withdrawn their consent. 2. Participants with sufficient surplus samples for gene expression/mutation and pathomorphologic (IHC, IF and/or ISH, etc.) analysis.
Exclusion criteria
Participants who are considered inappropriate for participation in this study by the research institution.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | Up to approximately 63 months | OS obtained in the main study will be stratified by the gene expression levels in tumor tissues at the baseline of the main study to evaluate the relationship between OS and gene expression. OS will be measured as the time from the date of randomization to the date of death due to any causes. |
| Progression-Free Survival (PFS) | Up to approximately 63 months | PFS obtained in the main study will be stratified by the gene expression levels in tumor tissues at the baseline of the main study to evaluate the relationship between the PFS and gene expression. PFS is defined as the time from the date of randomization to the earlier of Progressive Disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or death due to any cause. |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of Correlation between Change in Each Gene Mutations in Plasma Free DNA at Baseline and Discontinuation of Protocol Treatment of Main Study, and Efficacy Endpoints (OS and PFS) | Up to approximately 63 months |
| Evaluation of Correlation between Change in Each Gene Expression Levels in Tumor Tissue at Baseline and Discontinuation of Protocol Treatment of Main Study, and Efficacy Endpoints (OS and PFS) | Up to approximately 63 months |
| Evaluation of Correlation between Each Gene Mutations in Plasma Free DNA at Baseline of Main Study, and Efficacy Endpoints (OS and PFS) | Up to approximately 63 months |
| Evaluation of Correlation between Change in Gene Expression Region in Tumor Tissue at Baseline and Discontinuation of Protocol Treatment of Main Study, and Efficacy Endpoints (OS and PFS) | Up to approximately 63 months |
| Evaluation of Correlation between High Gene Expression Region in Tumor Tissue at Baseline of Main Study, and Efficacy Endpoints (OS and PFS) | Up to approximately 63 months |
| Evaluation of Correlation between Each Gene Expression Levels in Tumor Tissue at Baseline of Main Study, and Efficacy Endpoints (OS and PFS) | Up to approximately 63 months |
Countries
Japan
Outcome results
None listed