DPYD-guided fluoropyrimidine dose adjustment for patients with one DPYD gene variant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, phase 4, multi-center comparison of DPYD-guided dose reduction versus standard dosing for patients starting 5‑FU or capecitabine. Patients with a single (heterozygous) DPYD variant are assigned to reduced fluoropyrimidine dosing and compared with patients with wild-type DPYD receiving standard doses, with severe (Grade 3–4) FP-related toxicities as the primary outcome. The trial enrolls adults in adjuvant or metastatic settings and accepts both measurable and non-measurable disease, using real-world clinical workflows and CLIA-certified DPYD testing before treatment. Participating sites are regional cancer centers affiliated with Rutgers and RWJBarnabas Health in New Jersey.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Howard S. Hochster, MD — Study Principal Investigator
• Study coordinator: Howard S Hochster, MD
• Email: howard.hochster@rutgers.edu
• Phone: 732-253-5618

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.