A more sustainable perioperative treatment regimen for gastroesophageal cancer —replacing 5-FU with capecitabine within the FLOT regimen

Conditions

Gastric Cancer, Esophageal cancer

Brief summary

The MTD will be established using a 3+3 dose escalation design in which the amount of DLTs will determine the MTD (see 6.1 Trial design for a detailed explanation)

Detailed description

Assessed by analyzing the AUCs of capecitabine metabolites and comparing them within each patient between the preoperative and postoperative settings. These AUC values will subsequently be used to calculate an AUC ratio, Percentage of patients discontinuing treatment due to treatment-related adverse events, Percentage of patients completing neoadjuvant treatment cycles, Percentage of patients completing adjuvant treatment cycles, Safety of the administered treatment, assessed by: - All treatment-related adverse events (AEs) according to CTCAEv6 - All serious adverse events (SAEs); - All postoperative complications Additionally, AEs preoperatively will be compared to AEs postoperatively.

Related papers

No related papers found yet.

Interventions

DRUGCapecitabine 500 mg film-coated tablets

DRUGCapecitabine 150 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The MTD will be established using a 3+3 dose escalation design in which the amount of DLTs will determine the MTD (see 6.1 Trial design for a detailed explanation)	—

Secondary

Measure	Time frame
Assessed by analyzing the AUCs of capecitabine metabolites and comparing them within each patient between the preoperative and postoperative settings. These AUC values will subsequently be used to calculate an AUC ratio, Percentage of patients discontinuing treatment due to treatment-related adverse events, Percentage of patients completing neoadjuvant treatment cycles, Percentage of patients completing adjuvant treatment cycles, Safety of the administered treatment, assessed by: - All treatment-related adverse events (AEs) according to CTCAEv6 - All serious adverse events (SAEs); - All postoperative complications Additionally, AEs preoperatively will be compared to AEs postoperatively.	—

Measure

Time frame

Assessed by analyzing the AUCs of capecitabine metabolites and comparing them within each patient between the preoperative and postoperative settings. These AUC values will subsequently be used to calculate an AUC ratio, Percentage of patients discontinuing treatment due to treatment-related adverse events, Percentage of patients completing neoadjuvant treatment cycles, Percentage of patients completing adjuvant treatment cycles, Safety of the administered treatment, assessed by: - All treatment-related adverse events (AEs) according to CTCAEv6 - All serious adverse events (SAEs); - All postoperative complications Additionally, AEs preoperatively will be compared to AEs postoperatively.

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Outcome results

None listed