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Dose Individualization of Chemotherapy in Patients With Gastrointestinal Cancers Lacking a Specific Liver Enzyme
Sponsor: UNICANCER
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
Official title: Dihydropyrimidine Dehydrogenase (DPD) Phenotype-guided Dose Individualization of Fluoropyrimidine-based Chemotherapy in DPD Deficient Patients With Gastrointestinal Cancers
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2025-01-20
Completion Date
2030-01
Last Updated
2025-01-27
Healthy Volunteers
No
Conditions
Interventions
FOLFOX regimen
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)
CAPOX regimen
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
Locations (34)
CHU Amiens
Amiens, France
Institut du Cancer Avignon Provence
Avignon, France
CH Aunay Bayeux
Bayeux, France
CH Cote Basque
Bayonne, France
CHU Besançon
Besançon, France
Centre François Baclesse
Caen, France
Polyclinique du Parc - Centre d'Oncologie Maurice Tubiana
Caen, France
CHU Clermont Ferrand
Clermont-Ferrand, France
Hopital Beaujon
Clichy, France
Hopital Henri Mondor
Créteil, France
CHU Dijon
Dijon, France
GH Mutualiste de Grenoble
Grenoble, France
Hopital Privé Drome-Ardeche
Guilherand-Granges, France
CHU Dupuytren
Limoges, France
Hopital Privé Jean Mermoz
Lyon, France
Centre Léon Bérard
Lyon, France
Grand Hopital de l'Est Francilien
Meaux, France
Hopital Nord Franche Comté - Site du Mittan
Montbéliard, France
Centre Antoine Lacassagne
Nice, France
CHU d'Orléans
Orléans, France
Institut Curie
Paris, France
Hopital Saint Louis
Paris, France
Hopital Saint Antoine
Paris, France
GH Diaconesses Croix St Simon
Paris, France
CHU Bordeaux
Pessac, France
Hospices Civiles de Lyon
Pierre-Bénite, France
CHU Poitiers
Poitiers, France
Hopital Robert Debré
Reims, France
Institut Jean Godinot
Reims, France
CH de Saint Malo
St-Malo, France
Institut du Cancer de Strasbourg
Strasbourg, France
CHU de Toulouse
Toulouse, France
Hopital Bretonneau
Tours, France
Gustave Roussy Cancer Campus
Villejuif, France