A Prospective Study of Pharmacogenetic Factors and Gene Expression Profile in Patients Receiving Adjuvant Therapy With FOLFOX-6 After Curative Resection of Colon Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 2,660
- 试验地点
- 1
- 主要终点
- disease-free survival
研究概览
简要总结
This study is a parallel translational study of a Randomized Phase III trial Investigating the Role of Oxaliplatin duration (6 Cycles Versus 12 Cycles) in modified FOLFOX-6 Regimen as Adjuvant Therapy for Patients with Stage II/III Colon Cancer (MIDAS trial: protocol NCCCTS-467) . Patients participating in the trial will be provided with the informed consent of this parallel study, and peripheral blood and tumor tissue of those who signed the consent will be collected for germline polymorphism analysis and gene expression profile study .
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Curatively resected, histologically confirmed colon adenocarcinoma (presence of the inferior pole of the tumor above the peritoneal reflection)
- •AJCC/UICC high-risk stage II, stage III colon cancer Stage II patient with high risk of relapse, if they fulfill one or more of the following criteria:(T4 tumors,bowel obstruction or perforation,vascular or lymphatic or perineural invasion)
- •Patients who are participating in the randomized phase II trial of FOLFOX 6 or 12 cycles
- •Patients should sign a written informed consent for this translational study before or during participating in a randomized phase III study investigating the role of oxaliplatin duration (6 cycles versus 12 cycles) in modified FOLFOX-6 regimen as adjuvant therapy for patients with stage II/III colon cancer
排除标准
- •Patients who do not agree with sampling of peripheral blood for genetic analysis
- •Patients who are considered not to be suitable for this study at investigator's discretion
结局指标
主要结局
disease-free survival
时间窗: 6years
To estimate the interaction between disease-free survival, duration of adjuvant oxaliplatin treatment, and genotypes concerning DNA repair (ERCC1, XPD, XRCC1) and detoxification (GSTP1)
次要结局
未报告次要终点
研究者
Young Suk Park
Professor of Medicine, Sungkyunkwan University School of Medicine, Department of Hematology and Oncology
Samsung Medical Center