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RecruitingPhase 4NCT07158164

DPYD Pharmacogenomics and Fluoropyrimidine (FP) Dose-Adjustment

Sponsor

Rutgers, The State University of New Jersey

Enrollment

100 participants

Start Date

Aug 27, 2025

Study Type

INTERVENTIONAL

Conditions

Breast NeoplasmsColorectal NeoplasmsHead and Neck NeoplasmsGastro-Intestinal Intraepithelial Neoplasia

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study examines whether reducing the dose of certain chemotherapy drugs (fluoropyrimidines, such as 5-FU or capecitabine) based on genetic testing can make treatment safer for cancer patients. Some people have a genetic variant in a gene called DPYD that makes them process these drugs more slowly — increasing the risk of serious side effects at standard doses. **You may be eligible if...** - You have been diagnosed with cancer and are starting treatment with 5-FU or capecitabine for the first time - You have had DPYD genetic testing done by a certified lab before starting chemotherapy - Your ECOG performance status is 0–2 **You may NOT be eligible if...** - Your doctor does not consider 5-FU or capecitabine appropriate for you - You have two DPYD gene variants (homozygous) — these patients should not receive standard fluoropyrimidine therapy at all Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFluorouracil injection

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

DRUGXeloda

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

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NCT07158164

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