Dose Individualization of Chemotherapy in Patients With Gastrointestinal Cancers Lacking a Specific Liver Enzyme

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

Trial Details

NCT ID
NCT06475352
Phase
PHASE2
Sponsor
UNICANCER
Status
RECRUITING
Cancer Type
Liver Cancer
Interventions
  • FOLFOX regimen
  • CAPOX regimen
Locations (sample)
  • Amiens, France|49.9,2.3
  • Aurillac, France|44.92539,2.43983
  • Avignon, France|43.94834,4.80892
  • Bayeux, France|49.27732,-0.7039
  • Bayonne, France|43.49316,-1.473

Key Eligibility Criteria

  • Patients with pre-treatment screening based on \[U\] value according to INCa/HAS recommendations.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) ≤2
  • Fluoropyrimidine-naïve patients with gastrointestinal cancer starting chemotherapy combining fluoropyrimidine (5-FU or capecitabine) and oxaliplati…
  • biweekly 5-FU and oxaliplatin (FOLFOX) +/- targeted therapy (TT)

For full eligibility, visit ClinicalTrials.gov.

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