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โ† Trials
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DPYD Pharmacogenomics and Fluoropyrimidine (FP) Dose-Adjustment

RecruitingPhase 4Ages 18 Years - anyAllRutgers, The State University of New Jersey
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Fluorouracil injection
  • Xeloda
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Where

12 sites
RWJBarnabas Health Clara Maas Medical Center
Belleville, United States
Trinitas Hospital and Comprehensive Cancer Center
Elizabeth, United States
RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton
Hamilton, United States
RWJBarnabas Health Jersey City Medical Center
Jersey City, United States
Cooperman Barnabas Medical Center
Livingston, United States
Jack and Sheryl Morris Cancer Center
New Brunswick, United States
RWJBarnabas Health - Robert Wood Johnson University Hospita
New Brunswick, United States
Cancer Center Initiative
Newark, United States

โ€ฆand 4 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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