Study of DPYD Gene Testing to Guide Fluoropyrimidine Chemotherapy Dosing in Adults with Various Cancers

What this Trial Is About

This research aims to evaluate the safety and effectiveness of adjusting fluoropyrimidine FP chemotherapy doses based on genetic testing for DPYD variants in cancer patients. The study focuses on patients with cancers such as colorectal, breast, head and neck, and gastrointestinal neoplasms. It compares the occurrence of severe FP-related toxicities in patients with one DPYD gene variant receiving reduced doses against patients with normal DPYD genes receiving standard doses. This prospective treatment study seeks to validate DPYD-guided dosing strategies in a real-world clinical setting. Participants receive treatment in two groups the control arm receives 100% of standard FP doses according to the BEACON order plan, with dose reductions applied if severe toxicities occur. The experimental arm includes patients with one DPYD variant who start with 50% of the regular FP dose for the first two cycles, with possible dose escalation if tolerated. The chemotherapy drugs studied include Fluorouracil injection and Xeloda Capecitabine. Throughout the study, participants are monitored for severe fluoropyrimidine-related toxicities Grade 3 to 5 over a period of up to 24 months. Researchers will also track patterns of dose modifications, such as reductions or escalations. The study involves genetic testing before therapy, regular assessments of treatment response and safety, and follow-up to measure outcomes related to toxicity and treatment adjustments.

DPYD Pharmacogenomics and Fluoropyrimidine (FP) Dose-Adjustment