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OncoMatch/Clinical Trials/NCT07158164

DPYD Pharmacogenomics and Fluoropyrimidine (FP) Dose-Adjustment

Is NCT07158164 recruiting? Yes, currently enrolling (May 2026). This Phase 4 trial studies multiple treatments including Fluorouracil and Xeloda for colorectal neoplasms.

Phase 4RecruitingRutgers, The State University of New JerseyNCT07158164Data as of May 2026

Treatment: Fluorouracil · Xeloda — 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.

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Breast Carcinoma

Head and Neck Squamous Cell Carcinoma

Biomarker criteria

Required: DPYD one variant in one gene (heterozygotes)

Study Cohort: Patients with one DPYD variant in one gene (heterozygotes).

Required: DPYD normal or wild-type

Control Arm: Patients with normal or wild-type DPYD genes, for comparison, will be treated at the usual 100% dose.

Excluded: DPYD two variants (homozygous deletions or non-functional genetic variants, or double heterozygotes with two different abnormalities)

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.

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • RWJBarnabas Health Clara Maas Medical Center · Belleville, New Jersey
  • Trinitas Hospital and Comprehensive Cancer Center · Elizabeth, New Jersey
  • RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton · Hamilton, New Jersey
  • RWJBarnabas Health Jersey City Medical Center · Jersey City, New Jersey
  • Cooperman Barnabas Medical Center · Livingston, New Jersey

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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