TDM of 5-FUTHOMAS FU FLOTNCT05620524
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
An observational study of TDM of 5-FU and Pharmacokinetic Observational Study, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TDM of 5-FU, Pharmacokinetic Observational Study
- What is being tested?
- Extra blood samples for determining exposure to 5-FU
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 19 Dec 2022to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with locally advanced, resectable gastric or gastro-esophageal junction cancer treated with perioperative FLOT.
Who may be able to join
- Pathologically confirmed malignancy for which treatment with 5-FU is indicated in the FLOT regimen.
- Age ≥ 18 years
- Patient is able and willing to give written informed consent
- WHO performance status 0-2
- Patient fulfills the general treatment criteria for treatment with FLOT including appropriate liver and renal function and other standard applicable laboratory values
- Patient is able and willing to undergo extra blood sampling for 5-FU analysis
Who cannot join
- Patients with known substance abuse, psychotic disorders, and/or other diseases expected to interfere with study or the patient's safety.
- Inability to undergo additional blood sampling.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Catharina hospital
Eindhoven, North Brabant, 5623 EJ
Thomas Manten, MSc, +31652128256, thomas.manten@catharinaziekenhuis.nl
Maarten Deenen, Dr, 040 239 8797, maarten.deenen@catharinaziekenhuis.nl
About this study
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.
- Conditions
- TDM of 5-FU, Pharmacokinetic Observational Study
- Being tested
- Extra blood samples for determining exposure to 5-FU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extra blood samples for determining exposure to 5-FUDrug
Extra blood samples for determining exposure to 5-FU
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with FLOT regimen | Exposure to 5-FU in patients treated with FLOT Receives: Drug: Extra blood samples for determining exposure to 5-FU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Population exposure to 5-FU
AUC of 5-FU in FLOT treated patients
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start19 Dec 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TDM of 5-FUStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Manten, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05620524
- Sponsor's protocol ID
- THOMAS FU FLOT-001
- Acronym
- THOMAS FU FLOT
- Status last verified
- Dec 2022
- First submitted
- 10 Nov 2022
- Last updated
- 30 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05620524
- Acronym / sponsor ID
- THOMAS FU FLOT / THOMAS FU FLOT-001
- Conditions
- TDM of 5-FU, Pharmacokinetic Observational Study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Study start
- 19 Dec 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 17 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with FLOT regimen | – | Drug: Extra blood samples for determining exposure to 5-FUExposure to 5-FU in patients treated with FLOT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with locally advanced, resectable gastric or gastro-esophageal junction cancer treated with perioperative FLOT.
Key inclusion criteria (6 listed)
- Pathologically confirmed malignancy for which treatment with 5-FU is indicated in the FLOT regimen.
- Age ≥ 18 years
- Patient is able and willing to give written informed consent
- WHO performance status 0-2
- Patient fulfills the general treatment criteria for treatment with FLOT including appropriate liver and renal function and other standard applicable laboratory values
Key exclusion criteria (2 listed)
- Patients with known substance abuse, psychotic disorders, and/or other diseases expected to interfere with study or the patient's safety.
- Inability to undergo additional blood sampling.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extra blood samples for determining exposure to 5-FUExtra blood samples for determining exposure to 5-FU | Drug | Patients treated with FLOT regimen |
Primary outcome
Population exposure to 5-FU
Time frame: 1 year
AUC of 5-FU in FLOT treated patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of TDM of 5-FU and Pharmacokinetic Observational Study, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Manten, MSc. (+31652128256, thomas.manten@catharinaziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Population exposure to 5-FU (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2022.