Recruiting

DPYD-Guided DosingDPYD Pharmacogenomics and Fluoropyrimidine (FP) Dose-Adjustment

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT07158164

Conditions

Colorectal Neoplasms

Breast Neoplasms

Head and Neck Neoplasms

Gastro-Intestinal Intraepithelial Neoplasia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fluorouracil injection

Xeloda

Study Details

Brief 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.

Conditions

Colorectal Neoplasms

Breast Neoplasms

Head and Neck Neoplasms

Gastro-Intestinal Intraepithelial Neoplasia

Study ID

NCT07158164

Start date

Aug 27, 2025

Status verified date

Nov, 2025

Completion date

Jul 7, 2029

Anticipated

Primary completion date

Jul 7, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Normal DPYD Patients (Control Arm)

Should receive 100% of the standard recommended doses as per the BEACON order plan.

Dose Reduction for Toxicity: Reduce doses by 25% for unacceptable Grade 3 or any Grade 4 toxicity or clinically significant laboratory anbormaillity. If this occurs again, an additional 25% reduction (to 50% of the initial doses) should be used.

experimental: Patients with One DPYD Variant (Heterozygotes)

Will receive 50% of the regular starting doses for the first two cycles. For example, for FOLFOX or FOLFIRI, the 5FU bolus would be 200 mg/m², and the infusion would be 46 hours at 1200 mg/m².

Interventions

Fluorouracil injection

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

Xeloda

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

Primary outcome measure

incidence of severe fluoropyrimidine-related toxicities (Grade 3-5) [ Time Frame: up to 24 months ]

Central Contacts and Locations

Central contacts

Howard S Hochster, MD

732-253-5618 howard.hochster@rutgers.edu

Christian F Misdary

732-253-5618 cm1344@cinj.rutgers.edu

Locations

RWJBarnabas Health Clara Maas Medical Center

Recruiting

Belleville, New Jersey, United States, 07109

Contacts

Howard S Hochster, MD

732-253-5618 howard.hochster@rutgers.edu

Trinitas Hospital and Comprehensive Cancer Center

Recruiting

Elizabeth, New Jersey, United States, 07202

Contacts

Howard S Hochster, MD

732-253-5618 howard.hochster@rutgers.edu

RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton

Recruiting

Hamilton, New Jersey, United States, 08690

Contacts

Howard S Hochster, MD

732-253-5618 howard.hochster@rutgers.edu

RWJBarnabas Health Jersey City Medical Center

Recruiting

Jersey City, New Jersey, United States, 07302

Contacts

Howard S Hochster, MD

732-253-5618 howard.hochster@rutgers.edu

Cooperman Barnabas Medical Center

Recruiting

Livingston, New Jersey, United States, 07039

Contacts

Howard S Hochster, MD

732-253-5618 howard.hochster@rutgers.edu

Jack and Sheryl Morris Cancer Center

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Howard S Hochster, MD

732-253-5618 howard.hochster@rutgers.edu

RWJBarnabas Health - Robert Wood Johnson University Hospita

Recruiting

New Brunswick, New Jersey, United States, 08903

Contacts

Howard S Hochster, MD

732-253-5618 howard.hochster@rutgers.edu

Cancer Center Initiative

Recruiting

Newark, New Jersey, United States, 07103

Contacts

Howard S Hochster, MD

732-235-5618 howard.hochster@rutgers.edu

University Hospital

Recruiting

Newark, New Jersey, United States, 07103

Contacts

Howard S Hochster, MD

732-253-5618 howard.hochster@rutgers.edu

RWJBarnabas Health Newark Beth Israel Medical Center

Recruiting

Newark, New Jersey, United States, 07112

Contacts

Howard S Hochster, MD

732-253-5618 howard.hochster@rutgers.edu

RWJBarnabas Health - Robert Wood Johnson University Hospital Somerset

Recruiting

Somerville, New Jersey, United States, 08873

Contacts

Howard S Hochster, MD

732-253-5618 howard.hochster@rutgers.edu

RWJBarnabas Health - Community Medical Center

Recruiting

Toms River, New Jersey, United States, 08755

Contacts

Howard S Hochster, MD

732-253-5618 howard.hochster@rutgers.edu

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Nov 13, 2025

Last verified

Nov, 2025

Keywords

colorectal cancer
breast cancer
head and neck cancer
Gastro-Intestinal cancer
chemotherapy toxicity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2025-11-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.