Fluorouracil for Pancreatic cancer

Inclusion criteria

• {"criterion_text":"- Pathologically confirmed pancreatic cancer diagnosis (for PART B: unresectable locally advanced or metastatic setting)"}
• {"criterion_text":"- Patient scheduled to start FOLFIRINOX treatment"}
• {"criterion_text":"- Patient with age ≥ 18"}
• {"criterion_text":"- Patient is able and willing to give written IFC"}
• {"criterion_text":"- Patient is able and willing to undergo extra blood sampling for 5-FU analysis"}
• {"criterion_text":"- WHO performance status 0-2"}

Exclusion criteria

• {"criterion_text":"- Patient with known substance abuse, psychotic disorders, and/or other diseases expected to interfere with study or patient’s safety"}
• {"criterion_text":"- Patient with DPYD gene-activity score 0 and 0.5"}

Primary endpoints

• {"endpoint_text":"- Percentage of patients undergoing FOLFIRINOX treated with standard-dosed (BSA) 5-FU achieving a 5-FU target AUC range (5-FU AUC0-46h between 20 and 30 mg*h/L) within two dose cycles of 5-FU","definition_or_measurement_approach":"Proportion of enrolled patients on BSA-dosed FOLFIRINOX whose 5-FU AUC0-46h is between 20 and 30 mg*h/L within two dose cycles (measured by 5-FU plasma AUC0-46h assessment)."}
• {"endpoint_text":"- Percentage of patients undergoing FOLFIRINOX treated with 5-FU MIPD achieving a 5-FU target AUC range (5-FU AUC0-46h between 20 and 30 mg*h/L) within two dose cycles of 5-FU","definition_or_measurement_approach":"Proportion of enrolled patients on FOLFIRINOX with model-informed precision dosing (MIPD) whose 5-FU AUC0-46h is between 20 and 30 mg*h/L within two dose cycles (measured by 5-FU plasma AUC0-46h assessment)."}

Secondary endpoints

• {"endpoint_text":"- Incidence of grade ≥ 1-5 toxicity, toxicity-related hospitalization, treatment delay (> 2 days) and early treatment withdrawal in patients treated with FOLFIRINOX","definition_or_measurement_approach":"Incidence rates of CTCAE grade 1–5 toxicities, count of toxicity-related hospitalisations, treatment delays >2 days, and early withdrawals among treated patients."}
• {"endpoint_text":"- Turn-around-time of 5-FU MIPD (or incidence of treatment delay due to 5-FU MIPD)","definition_or_measurement_approach":"Measured time (turn-around time) for 5-FU MIPD processing and/or the incidence of treatment delays attributable to 5-FU MIPD."}
• {"endpoint_text":"- Compliance to 5-FU MIPD dosing advice by treating physicians","definition_or_measurement_approach":"Proportion of dosing recommendations from 5-FU MIPD that are followed by treating physicians (compliance rate)."}
• {"endpoint_text":"- Pharmacokinetics of 5-FU, FUH2, Irinotecan, SN-38, SN38G and Oxaliplatin","definition_or_measurement_approach":"PK parameters (e.g. AUC) for listed compounds measured in plasma samples per protocol."}
• {"endpoint_text":"- Direct medical costs of 5-FU based treatment","definition_or_measurement_approach":"Assessment of direct medical costs associated with 5-FU–based treatment (healthcare utilisation/cost analysis)."}
• {"endpoint_text":"- Disease free surivival, progression free survival, objective response rate and overall survival of patients treated with FOLFIRINOX","definition_or_measurement_approach":"Standard efficacy outcomes: DFS, PFS, ORR, and OS assessed per clinical/radiological criteria and follow-up."}
• {"endpoint_text":"- AUC0-46h of 5-FU in patients treated with FOLFIRINOX","definition_or_measurement_approach":"Measured 5-FU AUC0-46h values in plasma per sampling schedule."}
• {"endpoint_text":"- Correlation of patient and treatment characteristics with AUC of 5-FU and/or irinotecan and their metabolites","definition_or_measurement_approach":"Statistical correlation analyses between patient/treatment characteristics and measured AUC values of 5-FU, irinotecan and metabolites."}

Netherlands

Earliest CTIS Part Ii Submission Date

11-06-2024

Latest Decision Or Authorization Date

09-07-2024

Processing Time Days

28

Number Of Sites

5

Number Of Participants

100

Primary sponsor

Full Name

Catharina Ziekenhuis Stichting

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands