NCT07158164 · Rutgers, The State University of New Jersey
DPYD Pharmacogenomics and Fluoropyrimidine (FP) Dose-Adjustment
What this study is about
To prospectively evaluate the effectiveness 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 treatment group$1.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 1\. Diagnosis of cancer in either the adjuvant or metastatic setting requiring initial therapy with 5-FU or Capecitabine. 2\. 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. 3\. 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) 4. ECOG Performance Status 0-2. 5. Measurable disease or non-measurable disease allowed, including adjuvant 5-FU-based regimens.
Exclusion criteria
- 1\. Patients for whom 5-FU or Capecitabine therapy is contraindicated or not deemed appropriate in the judgment of th
Where
- Belleville, New Jersey
- Elizabeth, New Jersey
- Hamilton, New Jersey
- Jersey City, New Jersey
- Livingston, New Jersey
- New Brunswick, New Jersey
- Newark, New Jersey
- Somerville, New Jersey
- Toms River, New Jersey
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 13, 2025 · Source of record for eligibility and locations