At a glance
ClinicalIndex Comparison Record- ✓Fluoropyrimidine-naïve patients with gastrointestinal cancer starting chemotherapy combining fluoropyrimidine (5-FU or capecitabine) and oxaliplatin
- ✓Regimens: biweekly FOLFOX or three-weekly CAPOX with or without targeted therapy
- ✓Pre-treatment screening based on [U] value according to INCa/HAS recommendations
- ✓Age ≥18 years
- ✕Complete DPD deficiency based on [U] ≥150 ng/mL
- ✕Any prior treatment including a fluoropyrimidine
- ✕Any contraindication to treatment with fluoropyrimidine or oxaliplatin regardless of DPD deficiency
- ✕Not eligible for full standard dose fluoropyrimidine and oxaliplatin for clinical reasons including older age and/or comorbidity
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Dihydropyrimidine Dehydrogenase (DPD) Phenotype-guided Dose Individualization of Fluoropyrimidine-based Chemotherapy in DPD Deficient Patients With Gastrointestinal Cancers
In Brief
A Phase 2 clinical trial evaluating FOLFOX regimen and CAPOX regimen for Digestive Cancer and Colorectal Cancer. Currently recruiting, targeting 400 participants across 41 sites.
Signals
Detailed 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
Study Details
Timeline
Interventions
Oxaliplatin will be administered at a fixed dose of 85 mg/m² by 2h intravenous (IV) infusion concurrently with folinic acid 400 mg/m² (or 200 mg/m² if L-folinic acid) as a 2 h IV infusion on day 1 of each 14-day cycle followed by 5-fluorouracil (5-FU) 400 mg/m² IV bolus on day 1, then continuous IV infusion of 1,200 mg/m² /day × 2 days (total 2400 mg/m² for 46-48 hours)
Oxaliplatin will be administered at a fixed dose of 130 mg/m² by 2h IV infusion on day 1 of each 21-day cycle followed by capecitabine (1000 mg/m²) twice a day (BID) during 2 weeks, every 3 weeks