MedTrace Logo

Improving the Safety of Fluoropyrimidine-based Chemotherapy

NCT04194957 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1440

Last updated 2020-01-22

No results posted yet for this study

Summary

In this study it will be determined whether the rate of severe toxicity associated with fluoropyrimidine treatment (capecitabine or 5-fluorouracil) can be significantly diminished by individualized dosing of fluoropyrimidines based on upfront phenotypic assessment of dihydropyrimidine dehydrogenase (DPD) deficiency.

Conditions

  • Neoplasms

Interventions

DRUG

Fluoropyrimidine (capecitabine or 5-fluorouracil)

Patients that are found to be wild type and have a pre-treatment uracil concentration above 16 ng/mL will receive a reduced dosage of capecitabine or 5-fluorouracil (50% reduction). The dose will be titrated after 2 cycles , to achieve maximal safe exposure. Patients that are wildtype with a uracil concentration below 16 ng/mL will receive a normal (full) dose.

DRUG

Fluoropyrimidine (capecitabine or 5-fluorouracil)

Patients that are heterozygous carriers of c.1236G\>A or c.2846A\>T DPYD variant will receive a reduced dosage of capecitabine or 5-FU (50 % reduction). The dose will be titrated after 2 cycles, to achieve maximal safe exposure.

DRUG

Fluoropyrimidine (capecitabine or 5-fluorouracil)

Patients with homozygous or compound heterozygous DPYD variants will be treated with a reduced dose of capecitabine or 5-FU based on the DPD enzyme activity measured in peripheral blood mononuclear cells.

Sponsors & Collaborators

  • Leiden University Medical Center

    collaborator OTHER

  • The Netherlands Cancer Institute

    lead OTHER

Principal Investigators

  • Annemieke Cats, MD, PhD · Netherlands Cancer Institute - Antoni van Leeuwenhoek

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-15
Primary Completion
2021-01-31
Completion
2021-01-31

Countries

  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04194957 on ClinicalTrials.gov