Dose Individualization of Chemotherapy in Patients With Gastrointestinal Cancers Lacking a Specific Liver Enzyme
NCT Number: NCT06475352
Acronym: FUDOSE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Digestive Cancer|Colorectal Cancer
Interventions: DRUG: FOLFOX regimen|DRUG: CAPOX regimen
Sponsor: UNICANCER
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2029-10

Summary:
The goal of this clinical trial is to establish guidelines for fluoropyrimidine dose reduction according to uracilemia in patients with DPD deficiency in the treatment of digestive cancers. The main question it aims to answer is:

- Which reduction dose of fluoropyrimidine is needed for patient with DPD deficiency?

Participants will:

* Take the treatment with the reduction of dose stated by the protocol
* Visit the clinic once every 2-3 weeks for checkups and tests for collection of adverse events

Primary Outcome Measures: Proportion of fluoropyrimidine-induced grade ≥ 3 haematological and gastrointestinal toxicity after 2 cycles, The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders., Throughout the two first cycles of treatment, up to 42 days
Secondary Outcome Measures: Recommended fluoropyrimidine dose, The rate of fluoropyrimidine induced grade ≥ 3 haematological and gastrointestinal toxicity in each uracilemia-based group of DPD-deficient patients (according to uracilemia level) compared to the rate observed in non DPD-deficient patients (control arm), Throughout the four first cycles of treatment, up to 3 months|Description of fluoropyrimidine dose, The cumulative dose (mg/m²) of chemotherapy delivered to patients will be recorded along with reasons of dose-modifications or treatment discontinuation for limiting toxicity, Throughout the four first cycles of treatment, up to 3 months|Percentage of fluoropyrimidine dose modification, Percentage of patients for whom fluoropyrimidine dose is increased or decreased, Throughout the four first cycles of treatment, up to 3 months|Fluoropyrimidine toxicity during the study, The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders., Throughout the four first cycles of treatment, up to 3 months|Disease-free survival (DFS) - Stage III Colon Cancer, Disease-free survival is defined as the delay between date of inclusion and tumor relapse (local, regional, or distant) or death from any cause, whichever occurs first., 3 years|Overall survival (OS) - Stage III Colon Cancer, The overall survival is the length of time from randomization that patients enrolled in the study are still alive., From randomization to death from any cause, up to 3 years.|Progression-free survival (PFS) - Stage IV Colon Cancer, The progression-free survival is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse., From randomization to disease progression or death, up to 1 year.