A study of the dosage of the medicine 5-FU or capecitabine based on genetic testing and lab test results

Implementation of pre-emptive geno- and phenotyping in 5-FU- or capecitabine-treated patients with the aim of reducing toxicity

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004003-12-BE

Enrollment

300

Registered

2019-12-19

Start date

2020-01-14

Completion date

Unknown

Last updated

2025-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastro-intestinal cancers: stomach, pancreas, colon, rectum, anal tumors, esophagus

Interventions

Trade Name: Fluorouracil accord healthcare (5g/100 ml) Pharmaceutical Form: Concentrate for solution for injection/infusion INN or Proposed INN: FLUOROURACIL CAS Number: 51-21-8 Other descriptive nam

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The inclusion criteria are a probable start with 5-FU or capecitabine in mono- or combination therapy, the knowledge of the result of the geno- and phenotyping before the start of the treatment, being at least 18 years with a WHO status of 0, 1 or 2 and that the informed consent has been signed by the patient. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: Exclusion criteria are having a homozygous genotype or uracil of more than 100 ng / ml, not knowing the result of the geno- and/or phenotyping before the start of the treatment and already being treated with 5-FU or capecitabine in the past.

Design outcomes

Primary

Measure	Time frame
Main Objective: Implementation of pre-emptive geno- and phenotyping in 5-FU- or capecitabine-treated patients with the aim of reducing toxicity. The main objective of the trail is to investigate if dose reduction based on geno- and fenotyping reduces toxicity in 5-FU treated patients.;Secondary Objective: Not applicable;Primary end point(s): Toxicity;Timepoint(s) of evaluation of this end point: The toxicity will be determined by the doctor at every follow-up consultation or admission	—

Measure

Time frame

Main Objective: Implementation of pre-emptive geno- and phenotyping in 5-FU- or capecitabine-treated patients with the aim of reducing toxicity. The main objective of the trail is to investigate if dose reduction based on geno- and fenotyping reduces toxicity in 5-FU treated patients.;Secondary Objective: Not applicable;Primary end point(s): Toxicity;Timepoint(s) of evaluation of this end point: The toxicity will be determined by the doctor at every follow-up consultation or admission

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Belgium

Contacts

Public ContactLambaerts An

Jessa Hospital

an.lambaerts@jessazh.be

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026