Dose Individualization of Chemotherapy in Patients With Gastrointestinal Cancers Lacking a Specific Liver Enzyme
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUNICANCER
About this trial
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
Eligibility criteria
Qualifiers
Patients with pre-treatment screening based on [U] value according to INCa/HAS recommendations.
Eastern Cooperative Oncology Group performance status (ECOG PS) ≤2
biweekly 5-FU and oxaliplatin (FOLFOX) +/- targeted therapy (TT)
three-weekly capecitabine and oxaliplatin (CAPOX) +/- TT
Disqualifiers
Patients with complete DPD deficiency based on [U] ≥150 ng/mL
Any prior treatment including a fluoropyrimidine
Patients with any contraindication to treatment with fluoropyrimidine or oxaliplatin regardless of DPD deficiency
Patients not eligible for full standard dose fluoropyrimidine and oxaliplatin for clinical reasons including older age and/or comorbidity regardless of a DPD deficiency
Trial design
Treatments tested in this trial
- FOLFOX regimen
- CAPOX regimen
Treatment groups
400 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov