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Clinical Trials in Israel / NCT07158164
Recruiting Phase 4

DPYD Pharmacogenomics and Fluoropyrimidine (FP) Dose-Adjustment

NCT07158164 · tracked via the Priya Life Science Israel tracker
Phase
Phase 4
Started
2025-08-27
Last updated
2025-11-13

Condition(s) studied

Colorectal NeoplasmsBreast NeoplasmsHead and Neck NeoplasmsGastro-Intestinal Intraepithelial Neoplasia

Investigational drug(s) / intervention(s)

Fluorouracil injection →Xeloda →

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (12)

FacilityCityRegionStatus
RWJBarnabas Health Clara Maas Medical Center Belleville New Jersey Recruiting
Trinitas Hospital and Comprehensive Cancer Center Elizabeth New Jersey Recruiting
RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton Hamilton New Jersey Recruiting
RWJBarnabas Health Jersey City Medical Center Jersey City New Jersey Recruiting
Cooperman Barnabas Medical Center Livingston New Jersey Recruiting
Jack and Sheryl Morris Cancer Center New Brunswick New Jersey Recruiting
RWJBarnabas Health - Robert Wood Johnson University Hospita New Brunswick New Jersey Recruiting
Cancer Center Initiative Newark New Jersey Recruiting
University Hospital Newark New Jersey Recruiting
RWJBarnabas Health Newark Beth Israel Medical Center Newark New Jersey Recruiting
RWJBarnabas Health - Robert Wood Johnson University Hospital Somerset Somerville New Jersey Recruiting
RWJBarnabas Health - Community Medical Center Toms River New Jersey Recruiting

More Rutgers, The State University of New Jersey trials in Israel

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07158164 on ClinicalTrials.gov ↗ ← All trials in Israel