Actively Recruiting
DPYD Pharmacogenomics and Fluoropyrimidine Dose-Adjustment in Cancer Patients to Guide Chemotherapy Dosing
Led by Rutgers, The State University of New Jersey · Updated on 2025-11-13
100
Participants Needed
12
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of adjusting fluoropyrimidine (FP) chemotherapy doses based on genetic testing for DPYD variants in cancer patients. The study focuses on patients with cancers such as colorectal, breast, head and neck, and gastrointestinal neoplasms. It compares the occurrence of severe FP-related toxicities in patients with one DPYD gene variant receiving reduced doses against patients with normal DPYD genes receiving standard doses. This prospective treatment study seeks to validate DPYD-guided dosing strategies in a real-world clinical setting. Participants receive treatment in two groups: the control arm receives 100% of standard FP doses according to the BEACON order plan, with dose reductions applied if severe toxicities occur. The experimental arm includes patients with one DPYD variant who start with 50% of the regular FP dose for the first two cycles, with possible dose escalation if tolerated. The chemotherapy drugs studied include Fluorouracil injection and Xeloda (Capecitabine). Throughout the study, participants are monitored for severe fluoropyrimidine-related toxicities (Grade 3 to 5) over a period of up to 24 months. Researchers will also track patterns of dose modifications, such as reductions or escalations. The study involves genetic testing before therapy, regular assessments of treatment response and safety, and follow-up to measure outcomes related to toxicity and treatment adjustments.
CONDITIONS
Brief Title
DPYD Pharmacogenomics and Fluoropyrimidine (FP) Dose-Adjustment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of cancer requiring initial therapy with 5-FU or Capecitabine in either adjuvant or metastatic setting
- DPYD testing performed by a certified laboratory with results available before starting chemotherapy
- Patients with one DPYD variant (heterozygotes) or normal DPYD genes for comparison
- ECOG performance status between 0 and 2
- Measurable or non-measurable disease including adjuvant regimens
You will not qualify if you...
- Patients for whom 5-FU or Capecitabine therapy is contraindicated or not appropriate
- Patients with two DPYD variants (homozygous or double heterozygotes)
- Pregnant women
- Children
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive fluoropyrimidine chemotherapy with doses adjusted based on their DPYD gene status to reduce toxicity risks.
Regular visits according to chemotherapy schedule
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
C
Christian F Misdary
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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