DPYD Pharmacogenomics and Fluoropyrimidine (FP) Dose-Adjustment

Conditions

• Breast Neoplasms
• Colorectal Neoplasms
• Gastro-Intestinal Intraepithelial Neoplasia
• Head and Neck Neoplasms

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Fluorouracil injection — DRUG
  Experimental arm Fluorouracil injection with possible escalation to 75 or 100 percent if tolerated.
• Xeloda — DRUG
  Experimental arm Fluorouracil injection with possible escalation to 75 or 100 percent if tolerated.

Study Details

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.

Key Dates

Start date

Aug 27, 2025

Status verified

Nov 2025

Primary completion

Jul 7, 2027

Completion

Jul 7, 2029

Study Design

Enrollment

100 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Normal DPYD Patients (Control Arm)
  Should receive 100% of the standard recommended doses as per the BEACON order plan. Dose Reduction for Toxicity: Reduce doses by 25% for unacceptable Grade 3 or any Grade 4 toxicity or clinically significant laboratory anbormaillity. If this occurs again, an additional 25% reduction (to 50% of the initial doses) should be used.
• Experimental: Patients with One DPYD Variant (Heterozygotes)
  Will receive 50% of the regular starting doses for the first two cycles. For example, for FOLFOX or FOLFIRI, the 5FU bolus would be 200 mg/m², and the infusion would be 46 hours at 1200 mg/m².

Primary Outcome Measure

incidence of severe fluoropyrimidine-related toxicities (Grade 3-5) [ Time Frame: up to 24 months ]

Central Contacts

• Howard S Hochster, MD
  732-253-5618
  [email protected]
• Christian F Misdary
  732-253-5618
  [email protected]

Locations (12)

Find similar trials in Belleville, NJ

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