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DPYD Pharmacogenomics and Fluoropyrimidine (FP) Dose-Adjustment
RecruitingPhase 4
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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, including adjuvant 5-FU-based regimens. Exclusion Criteria: * Patients for whom 5-FU or Capecitabine therapy is contraindicated or not deemed appropriate in the judgment of the treating physician. * Patients with two DPYD variants (homozygous deletions or non-functional genetic variants, or double heterozygotes with two different abnormalities) should not receive 5-FU or Capecitabine and are therefore excluded from the study. * Pregnant Women and Children
About the study
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.
What is being tested
- Fluorouracil injection (drug)
- Xeloda (drug)
Sponsor: Rutgers, The State University of New Jersey · Participants: 100 · Started: Aug 27, 2025
Contact the study team
- Howard S Hochster, MD · Phone: 732-253-5618
- Christian F Misdary · Phone: 732-253-5618
Official record on ClinicalTrials.gov — NCT07158164
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.