Actively Recruiting
DPYD Pharmacogenomics and Fluoropyrimidine (FP) Dose-Adjustment
Led by Rutgers, The State University of New Jersey · Updated on 2025-11-13
100
Participants Needed
12
Research Sites
201 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
DPYD Pharmacogenomics and Fluoropyrimidine (FP) Dose-Adjustment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 with results available before starting chemotherapy.
- DPYD testing results showing one DPYD variant in one gene (heterozygotes) for the study cohort.
- Control arm includes patients with normal or wild-type DPYD genes treated at the usual 100% dose.
- Receiving first-line therapy with a fluoropyrimidine, including FOLFOX regimen.
- ECOG Performance Status 0-2.
- Measurable or non-measurable disease allowed, including adjuvant 5-FU-based regimens.
You will not qualify if you...
- Patients for whom 5-FU or Capecitabine therapy is contraindicated or not appropriate as judged by the treating physician.
- Patients with two DPYD variants (homozygous deletions, non-functional variants, or double heterozygotes).
- Pregnant women.
- Children.
AI-Screening
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Trial Site Locations
Total: 12 locations
1
RWJBarnabas Health Clara Maas Medical Center
Belleville, New Jersey, United States, 07109
Actively Recruiting
2
Trinitas Hospital and Comprehensive Cancer Center
Elizabeth, New Jersey, United States, 07202
Actively Recruiting
3
RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton
Hamilton, New Jersey, United States, 08690
Actively Recruiting
4
RWJBarnabas Health Jersey City Medical Center
Jersey City, New Jersey, United States, 07302
Actively Recruiting
5
Cooperman Barnabas Medical Center
Livingston, New Jersey, United States, 07039
Actively Recruiting
6
Jack and Sheryl Morris Cancer Center
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
7
RWJBarnabas Health - Robert Wood Johnson University Hospita
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
8
Cancer Center Initiative
Newark, New Jersey, United States, 07103
Actively Recruiting
9
University Hospital
Newark, New Jersey, United States, 07103
Actively Recruiting
10
RWJBarnabas Health Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
Actively Recruiting
11
RWJBarnabas Health - Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, United States, 08873
Actively Recruiting
12
RWJBarnabas Health - Community Medical Center
Toms River, New Jersey, United States, 08755
Actively Recruiting
Research Team
H
Howard S Hochster, MD
CONTACT
C
Christian F Misdary
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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