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

Launched by CATHARINA ZIEKENHUIS EINDHOVEN · Nov 10, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new way to monitor the drug 5-FU (fluorouracil) in patients with locally advanced stomach or gastro-oesophageal junction cancer who are receiving a treatment called FLOT. The goal is to see how effective this monitoring is in ensuring that patients get the right amount of 5-FU, which is important for both effectiveness and reducing side effects. Traditionally, the dosing of 5-FU has been based on body size, but this can lead to significant differences in how much of the drug each patient actually receives. This trial aims to find out how many patients receiving the FLOT regimen are within the ideal therapeutic range of the drug, which is believed to be comparable to older dosing methods.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of cancer for which 5-FU treatment is appropriate. They should also be healthy enough to tolerate the treatment and willing to provide consent and undergo extra blood tests to monitor the drug levels. Participants can expect to be closely monitored during their treatment, which may help improve their care and outcomes. Overall, this trial hopes to enhance how we use 5-FU in cancer treatment, making it safer and more effective for patients.

Gender

ALL

Eligibility 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.