DPYD Pharmacogenomics and Fluoropyrimidine (FP) Dose-Adjustment
To prospectively evaluate the efficacy and safety of DPYD-guided dosing strategies in a real-world clinical setting, specifically by comparing the incidence of severe (Grade 3 and 4) fluoropyrimidine-related toxicities of heterozygous DPYD variant patients assigned to DPYD-guided reduced dosing versus patients with sta
| Condition(s) | Colorectal Neoplasms, Breast Neoplasms, Head and Neck Neoplasms, Gastro-Intestinal Intraepithelial Neoplasia |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | To prospectively evaluate the efficacy and safety of DPYD-guided dosing strategies in a real-world clinical setting, specifically by comparing the incidence of severe (Grade 3 and 4) fluoropyrimidine-related toxicities of heterozygous DPYD variant patients assigned to DPYD-guided reduced dosing versus patients with standard dosing in the control arm. |
| Who can participate | Inclusion Criteria: * Diagnosis of cancer in either the adjuvant or metastatic setting requiring initial therapy with 5-FU or Capecitabine. * DPYD testing performed by a CLIA-certified laboratory (i.e., Guardant 360 or Caris blood testing for genomic profiling, DPYD testing by the Mayo Clinic or other certified laboratory) with results available before starting chemotherapy. * DPYD testing results falling into one of the following cohorts for first-line therapy with a fluoropyridine: * Study Cohort: Patients with one DPYD variant in one gene (heterozygotes). * Control Arm: Patients with normal or wild-type DPYD genes, for comparison, will be treated at the usual 100% dose. --FOLFOX regimen (N=50) * ECOG Performance Status 0-2. * Measurable disease or non-measurable disease allowed, includi |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Rutgers, The State University of New Jersey |
| Locations | Belleville, New Jersey, United States; Elizabeth, New Jersey, United States; Hamilton, New Jersey, United States; Jersey City, New Jersey, United States; Livingston, New Jersey, United States; New Brunswick, New Jersey, United States (+6 more sites) |
| Start date | 2025-08-27 |
| NCT ID | NCT07158164 |
| Official listing | https://clinicaltrials.gov/study/NCT07158164 |