Personalized prediction and regulation of 5-FU exposure

Personalized prediction and regulation of 5-FU exposure - PERFU

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54497

Enrollment

Registered

2019-11-19

Start date

2020-02-12

Completion date

Unknown

Last updated

2025-09-01

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

Conditions

intestinal cancer

Interventions

A 5-FU dosing algorithm will be applied in this study to adjust the 5-FU exposure in patients until the target window of 20-30 mg*h/L or dose limiting toxicity has been reached. All other procedures

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Patient undergoing FOLFOX, FOLFIRI or FOLFIRINOX treatment. 2. Patient with age >= 18. 3. Patient is able and willing to give written informed consent. 4. Patient is able and willing to undergo extra blood sampling for 5-FU analysis.

Exclusion criteria

Exclusion criteria: 1. Patients with known substance abuse, psychotic disorders, and/or other diseases expected to interfere with study or the patient*s safety. 2. Inability to perform additional blood sampling in patient.

Design outcomes

Primary

Measure	Time frame
The percentage of the patients that achieve optimal 5-FU exposure within two dose cycles of 5-FU, which is defined by an AUC target of 5-FU between 20 and 30 mg h/L or dose limiting toxicity.	—

Secondary

Measure	Time frame
Secondary endpoints of this study are: the minimum amount of blood sample required to safely adjust 5-FU dosing in our routine clinical practice, AUC contribution of 5-FU bolus infusion in PK model versus simple formula (Css x t), frequency of AEs below, within and above target window, intra-individual variation in 5-FU AUC, correlation DPD activity with 5-FU exposure and toxicity and the correlation between AEs and total 5-FU exposure.	—

Measure

Time frame

Secondary endpoints of this study are: the minimum amount of blood sample required to safely adjust 5-FU dosing in our routine clinical practice, AUC contribution of 5-FU bolus infusion in PK model versus simple formula (Css x t), frequency of AEs below, within and above target window, intra-individual variation in 5-FU AUC, correlation DPD activity with 5-FU exposure and toxicity and the correlation between AEs and total 5-FU exposure.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)