OncoMatch/Clinical Trials/NCT07158164
DPYD Pharmacogenomics and Fluoropyrimidine (FP) Dose-Adjustment
Is NCT07158164 recruiting? Yes, currently enrolling (Jun 2026). This Phase 4 trial studies multiple treatments including Fluorouracil and Xeloda for colorectal neoplasms.
Treatment: Fluorouracil · Xeloda — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Colorectal Cancer
Breast Carcinoma
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: DPYD one variant in one gene (heterozygotes)
Study Cohort: Patients with one DPYD variant in one gene (heterozygotes).
Required: DPYD normal or wild-type
Control Arm: Patients with normal or wild-type DPYD genes, for comparison, will be treated at the usual 100% dose.
Excluded: DPYD two variants (homozygous deletions or non-functional genetic variants, or double heterozygotes with two different abnormalities)
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.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- RWJBarnabas Health Clara Maas Medical Center · Belleville, New Jersey
- Trinitas Hospital and Comprehensive Cancer Center · Elizabeth, New Jersey
- RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton · Hamilton, New Jersey
- RWJBarnabas Health Jersey City Medical Center · Jersey City, New Jersey
- Cooperman Barnabas Medical Center · Livingston, New Jersey
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07158164 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require DPYD?
Yes, DPYD one variant in one gene (heterozygotes) is a required biomarker for enrollment.
Does this trial require DPYD?
Yes, DPYD normal or wild-type is a required biomarker for enrollment.
Are patients with DPYD alterations eligible?
No. DPYD two variants (homozygous deletions or non-functional genetic variants, or double heterozygotes with two different abnormalities) is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages