Association of the C677T and A1298C MTHFR Polymorphisms With Chemotherapy Effectiveness Among Patients With Metastatic Colorectal Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Assessment of C677T and A1298C MTHFR polymorphisms and overall survival
研究概览
简要总结
Fluoropyrimidines are the backbone of chemotherapy regimes used to treat metastatic colorectal cancer (CRC). These drugs act in different pathways of folate metabolism altering DNA synthesis mainly by inhibition of the tymidylate synthase. For this reaction the 5,10-methylenetetrahydrofolate acts as cofactor. It has been demonstrated that A1298C and C677T polymorphisms in the methylenetetrahydrofolate reductase (MTHFR) gene result in reduced enzyme activity that leads to reduced availability of this important cofactor. Hence, we hypothesized that the presence of these polymorphisms are related to the efficacy and toxicity of fluoropyrimidines in patients with CRC.
详细描述
Patients with metastatic colorectal cancer are invited to join this study at the start of treatment with any fluoropyrimidine used alone or in combination with oxaliplatin and/or irinotecan +/- bevacizumab, panitumumab or cetuximab. DNA extraction will be done from blood and tissue samples to determine the C677T (rs1801133) and 1298 A>C (rs18011131) polymorphisms of the MTHFR gene.
The patient will be followed at least for one year during treatment to determine any toxicity related to the therapy and to determine the overall survival, progression-free survival and response rate. Patients will be categorized into different categories according to the genetic status of each polymorphism.
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
- •Patients with metastatic colorectal cancer receiving first line therapy with any fluoropyrimidine (capecitabine or 5-Fluorouracil) alone or in association with oxaliplatin, and/or irinotecan, plus either bevacizumab or cetuximab/panitumumab.
排除标准
- •Any other malignant condition
结局指标
主要结局
Assessment of C677T and A1298C MTHFR polymorphisms and overall survival
时间窗: From the start date of treatment until the date of death from any cause, assessed up to 24 months
Overall survival
Assessment of C677T and A1298C MTHFR polymorphisms and response rate
时间窗: From the start date of treatment until the first radiological or clinical assessment, up to 6 months.
Response rate
Assessment of C677T and A1298C MTHFR polymorphisms and progression-free survival
时间窗: From the start date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Progression-Free survival
次要结局
- Assessment of C677T and A1298 MTHFR polymorphisms and toxicity(From treatment initiation to detected toxicity during treatment with any fluoropyrimidine alone or in combination with oxaliplatin, irinotecan or any biological treatment as first line therapy of colorectal metastatic cancer (up to 24 months))
研究者
Allan Ramos-Esquivel
Principal Investigator
Universidad de Costa Rica