There is one clinical trial.
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.
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.
Description: Overall survivalMeasure: Assessment of C677T and A1298C MTHFR polymorphisms and overall survival Time: From the start date of treatment until the date of death from any cause, assessed up to 24 months
Description: Progression-Free survivalMeasure: Assessment of C677T and A1298C MTHFR polymorphisms and progression-free survival Time: 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
Description: Response rateMeasure: Assessment of C677T and A1298C MTHFR polymorphisms and response rate Time: From the start date of treatment until the first radiological or clinical assessment, up to 6 months.
Description: Prospective assessment of toxicity according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) 4.0 criteria according to the C677T and A1298C polymorphismsMeasure: Assessment of C677T and A1298 MTHFR polymorphisms and toxicity Time: 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)