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RECRUITING
NCT06475352
PHASE2

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

Sponsor: UNICANCER

View on ClinicalTrials.gov

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

Interventions

DRUG

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)

DRUG

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