colorectal cancer
Conditions
Interventions
Trade Name: 5-FLUOROURACIL "EBEWE"
Product Name: 5-FLUOROURACIL "EBEWE"
Pharmaceutical Form: Injection*
Sponsors
University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male and female age of 18 to 80 years, inclusive, caucasian race, suffering from colorectal carcinoma Dukes C, indicated to neoadjuvant chemoradiotherapy. 2) Subject is available for the entire Study Period and will provide his written informed consent. 3) Physical examination without significant deviations. 4) Vital signs without significant deviations. 5) All laboratory screening results within the normal range or being assessed as non-significant by the attending physician. 6) Czech citizenship. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) History of severe allergy or allergic reactions to the study drugs or related drugs. 2) History of serious clinical illness that can impact on the fate of drugs. 3) Serious mental disease or inability to cooperate with clinical team. 4) Sitting blood pressure after a minimum 5-minute rest 120 bpm during the screening procedure. 5) Orthostatic hypotension during the screening procedure or in history. 6) Drug, alcohol or solvents abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 5-fluorouracil (5-FU) is the drug most commonly used in the treatment of patients with colorectal cancer. Its efficacy and toxicity can also be evaluated and predicted according to individual pharmacogenetic (PG), pharmacokinetic (PK) and dynamic data (PD). Individual PK is estimated according to drug plasma concentrations –Cpl and kinetic parameters of 5-FU, mainly the AUC as the measure of exposure to drugs. Clinical outcome which is evaluated according to PD parameters, is more depedent on pharmacokinetics than on the dose. This study is devoted to kinetally guided therapy with 5-FU.;Secondary Objective: a. The final effect of 5-FU is also dependent on PG conditions which determine enzymatic activity of DPD (dihydropyrimidin reductase), TS (thymidylate synthase), and MTHFR (methylfolate reductase). These enzymes undergo genetic polymorphism. There for this study is also interested in the genotype;Primary end point(s): interindividual variability in pharmacokinetics and dynamics (toxicity) | — |
Countries
Czech Republic
Outcome results
None listed