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Trial Title:
Therapeutic Oncolytic Monitoring as a Tool for Effective Exposure to 5-FU in Patients With Locally Advanced, Resectable Gastric or Gastro-oesophageal Junction Cancer Treated With Perioperative FLOT
NCT ID:
NCT05620524
Condition:
TDM of 5-FU
Pharmacokinetic Observational Study
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Extra blood samples for determining exposure to 5-FU
Description:
Extra blood samples for determining exposure to 5-FU
Arm group label:
Patients treated with FLOT regimen
Summary:
Traditional dosing of 5-FU is based on body surface area and DPD enzyme activity.
However, BSA-based dosing is associated with wide inter-individual variations in 5-FU
systemic exposure, and also 5-FU-induced toxicity. The international association for
therapeutic drug monitoring and clinical toxicology (IATDMCT) state in there clinical
guideline, in which all previous clinical pharmacokinetic studies of 5-FU were reviewed,
that only 25% of the patients are within the therapeutic range. In the traditional
treatment regimens a bolus of 400 mg/ m2 5-FU is given, followed by a dose of 2400 mg/m2
as a 46-hour infusion. The therapeutic range of 5-FU in these older regimens is defined
by a target AUC of 20-30 mg*h/L. In contrast, 5-FU in FLOT regimen is given without a
bolus, and in a high dose of 2600 mg/m2 as a 24-hour infusion. This means that a
comparable absolute dose of 5-FU is given with FLOT and the older regimens, however, the
manner and duration of administration differ. Based on this administration, it is
expected that the FLOT regimen will result in an approximately two-fold higher steady
state concentration (Css), as it is given in an approximately two-fold shorter period of
time (t). As a result of this pharmacokinetic predictions, the exposure to 5-FU (AUC =
Css x t) will be comparable between these different 5-FU regimens. Therefore, we
hypothesise that the therapeutic range of 5-FU in FLOT will be comparable to the target
AUC of 20-30 mg*h/L in the older regimens. Similar to the older treatment regimens, we
expect that a significant part of patients will be outside this therapeutic window. To
test these hypotheses, the aim of this study is to establish the population exposure of
5-FU in FLOT treatment regimen, and to determine the percentage of patients that achieves
this therapeutic range.
Criteria for eligibility:
Study pop:
Patients with locally advanced, resectable gastric or gastro-esophageal junction cancer
treated with perioperative FLOT.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Pathologically confirmed malignancy for which treatment with 5-FU is indicated in
the FLOT regimen.
2. Age ≥ 18 years
3. Patient is able and willing to give written informed consent
4. WHO performance status 0-2
5. Patient fulfills the general treatment criteria for treatment with FLOT including
appropriate liver and renal function and other standard applicable laboratory values
6. Patient is able and willing to undergo extra blood sampling for 5-FU analysis
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 undergo additional blood sampling.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Catharina hospital
Address:
City:
Eindhoven
Zip:
5623 EJ
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Thomas Manten, MSc
Phone:
+31652128256
Email:
thomas.manten@catharinaziekenhuis.nl
Contact backup:
Last name:
Maarten Deenen, Dr
Phone:
040 239 8797
Email:
maarten.deenen@catharinaziekenhuis.nl
Start date:
December 19, 2022
Completion date:
December 2023
Lead sponsor:
Agency:
Catharina Ziekenhuis Eindhoven
Agency class:
Other
Source:
Catharina Ziekenhuis Eindhoven
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05620524
