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

Phase 2 Recruiting 400 enrolled UNICANCER

Non-randomizedParallel-groupOpen-labelTreatment

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

Timeline

Start: 2025-01-20
Primary completion: 2027-04
Completion: 2030-01

Publications

Camilleri GM, Loriot MA, Teuff GL, Thuillier F, Bouche O, Narjoz C, Abdelghani MB, Herve C, Corbinais S, Locher C, Lecomte T, Villemin M, Tougeron D, Lepage C, Peytier A, Moussaddaq AS, Dubreuil O, Mabro M, Desrame J, Carvalho NS, Boige V. Dihydropyrimidine dehydrogenase phenotype-guided dose individualization of fluoropyrimidine in gastrointestinal cancers: PRODIGE100-UCGI48-FUDOSE phase II study. Dig Liver Dis. 2026 Jul;58(7):899-905. doi: 10.1016/j.dld.2026.04.016. Epub 2026 May 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Capecitabine	Small molecule	1000 mg/m2	—
Subject	fluorouracil	Small molecule	400 mg/m2	Intravenous
Subject	fluorouracil	Small molecule	1200 mg/m2	Intravenous
Background	Leucovorin	Small molecule	200 mg/m2	Intravenous
Background	Leucovorin	Small molecule	400 mg/m2	Intravenous
Background	Oxaliplatin	Small molecule	85 mg/m2	Intravenous
Background	Oxaliplatin	Small molecule	130 mg/m2	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications