Additional Exploratory Analysis of Biomarkers in the PARADIGM Exploratory Study in Patients With Advanced/Recurrent Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 787
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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Exploratory Study (NCT02394834) who have consented to the secondary use of samples and genomic data and have not withdrawn their consent.
- •Participants with sufficient surplus samples for gene expression/mutation and pathomorphologic (IHC, IF and/or ISH, etc.) analysis.
排除标准
- •Participants who are considered inappropriate for participation in this study by the research institution.
研究组 & 干预措施
Group P; mFOLFOX6 + panitumumab combination therapy
OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 panitumumab: 6 mg/kg mFOLFOX6 + panitumumab combination therapy, once every two weeks
干预措施: mFOLFOX6 + panitumumab combination therapy (Drug)
Group B; mFOLFOX6 + bevacizumab combination therapy
OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 bevacizumab: 5 mg/kg mFOLFOX6 + bevacizumab combination therapy, once every two weeks
干预措施: mFOLFOX6 + bevacizumab combination therapy (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: 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)
时间窗: 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.
次要结局
- 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 Each Gene Expression Levels in Tumor Tissue at Baseline 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 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 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)