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RECRUITING
NCT07158164
PHASE4

DPYD Pharmacogenomics and Fluoropyrimidine (FP) Dose-Adjustment

Sponsor: Rutgers, The State University of New Jersey

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-08-27

Completion Date

2029-07-07

Last Updated

2025-11-13

Healthy Volunteers

No

Interventions

DRUG

Fluorouracil injection

Experimental arm Fluorouracil injection with possible escalation to 75 or 100 percent if tolerated.

DRUG

Xeloda

Experimental arm Fluorouracil injection with possible escalation to 75 or 100 percent if tolerated.

Locations (12)

RWJBarnabas Health Clara Maas Medical Center

Belleville, New Jersey, United States

Trinitas Hospital and Comprehensive Cancer Center

Elizabeth, New Jersey, United States

RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton

Hamilton, New Jersey, United States

RWJBarnabas Health Jersey City Medical Center

Jersey City, New Jersey, United States

Cooperman Barnabas Medical Center

Livingston, New Jersey, United States

Jack and Sheryl Morris Cancer Center

New Brunswick, New Jersey, United States

RWJBarnabas Health - Robert Wood Johnson University Hospita

New Brunswick, New Jersey, United States

Cancer Center Initiative

Newark, New Jersey, United States

University Hospital

Newark, New Jersey, United States

RWJBarnabas Health Newark Beth Israel Medical Center

Newark, New Jersey, United States

RWJBarnabas Health - Robert Wood Johnson University Hospital Somerset

Somerville, New Jersey, United States

RWJBarnabas Health - Community Medical Center

Toms River, New Jersey, United States