Identification of the Prognostic Factors of Stage II Colon Cancer Patients Receiving Adjuvant Chemotherapy With UFT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,111
- 试验地点
- 152
- 主要终点
- mRNA levels
研究概览
简要总结
RATIONALE: Studying samples of tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict which patients will respond to treatment.
PURPOSE: This laboratory study is looking at prognostic factors in patients receiving tegafur-uracil for stage II colon cancer that was completely removed by surgery.
详细描述
OBJECTIVES:
- Identify the prognostic factors in patients with curatively resected stage II colon cancer receiving adjuvant chemotherapy with tegafur-uracil.
- Identify predictive factors of chemosensitivity to this regimen in these patients.
OUTLINE: Available tumor tissue samples are analyzed by real-time reverse transcriptase-PCR for TS, DPD, TP, OPRT, VEGF, cyclooxygenase-2, and FPGS; by PCR for microsatellite instability and genomic deletions on chromosome arm 18q; and pathologically for tumor budding, Crohn's-like lymphoid reaction, category of extent of poor differentiation, and fibrotic cancer stroma. The candidate prognostic and predictive markers are analyzed for correlation with disease-free survival, relapse-free survival, and overall survival of patients.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
UFT adjuvant therapy group
UFT is given at a dose of 500-600 mg/day as tegafur in 2 divided doses after meals for 5 days, followed by a 2-day rest. This one-week cycle is repeated for one year. During protocol treatment, clinical findings and laboratory values are evaluated every month. After the completion of protocol treatment, patients are followed-up, according to the schedule defined in the study protocol, for 5 years until recurrence, other malignancy or death is confirmed.
干预措施: UFT adjuvant chemotherapy (Drug)
结局指标
主要结局
mRNA levels
时间窗: 9years
mRNA levels of patients are analyzed by the Danenberg tumor profile (DTP) method in the following indicators: thymidylate synthase (TS), dihydropyrimidine dehydrogenase (DPD), thymidine phosphorylase (TP), orotate phosphoribosyltransferase (OPRT), folylpolyglutamate synthetase (FPGS) vascular endothelial growth factor (VEGF), and cyclooxygenase-2 (Cox-2) mRNA levels.
次要结局
- Analysis of microsatellite instability (MSI) and chromosomal instability (CIN)(At enrollment)
- Histopathological examination(At enrollment)