Status:
RECRUITING
DPYD Pharmacogenomics and Fluoropyrimidine (FP) Dose-Adjustment
Lead Sponsor:
Rutgers, The State University of New Jersey
Conditions:
Colorectal Neoplasms
Breast Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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-...
Detailed Description
Fluropyrimidines (FPs), such as 5-Fluorouracil (5-FU) and Capecitabine, are cornerstone chemotherapy agents widely used in the treatment of various cancers, including gastrointestinal, head and neck, ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 7 2029
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07158164
Start Date
August 27 2025
End Date
July 7 2029
Last Update
November 13 2025
Active Locations (12)
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1
RWJBarnabas Health Clara Maas Medical Center
Belleville, New Jersey, United States, 07109
2
Trinitas Hospital and Comprehensive Cancer Center
Elizabeth, New Jersey, United States, 07202
3
RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton
Hamilton, New Jersey, United States, 08690
4
RWJBarnabas Health Jersey City Medical Center
Jersey City, New Jersey, United States, 07302