Back to search results

DPYD-Guided Dosing for Fluoropyrimidine Chemotherapy

This study is looking at how to safely give chemotherapy drugs called fluoropyrimidines (like Fluorouracil injection and Xeloda) to people with certain cancers, including colorectal, breast, and head and neck cancers. These drugs can sometimes cause severe side effects. Researchers want to see if adjusting the dose based on a genetic test (DPYD test) can reduce these side effects. You can join if you have cancer requiring these specific chemotherapy drugs and have had a DPYD test from a certified lab. The main goal is to see how many people experience severe side effects (Grade 3-5) over 24 months. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 100 participants. It compares a DPYD-guided reduced dosing strategy to standard dosing.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for severe side effects for up to 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07158164

DPYD Pharmacogenomics and Fluoropyrimidine (FP) Dose-Adjustment

Recruiting
PHASE4Ages 18+InterventionalTreatment
Rutgers, The State University of New Jersey
~100 participants
Updated 2025-11-13 on ClinicalTrials.gov
What's tested:Fluorouracil injectionXeloda

At a glance

Recruiting sites
12 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
incidence of severe fluoropyrimidine-related toxicities (Grade 3-5)
Measured over up to 24 months

Conditions

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

Explore related trials

Breast CarcinomaColorectal CarcinomaGASTRIC CANCER, INTESTINALMalignant Head and Neck NeoplasmSolid NeoplasmDPYD Gene

Where it's being run

12 sites across 1 states
New Jersey12

Study leadership

  • Howard S. Hochster, MD · PRINCIPAL_INVESTIGATOR · Study Principal Investigator

Who to contact

Howard S Hochster, MD
[email protected]
732-253-5618
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
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

What this trial measures

  • incidence of severe fluoropyrimidine-related toxicities (Grade 3-5)up to 24 months

    Number and proportion of patients experiencing Grade 3, 4, or 5 toxicities related to 5-FU or Capecitabine, as defined by CTCAE v5.0.