Recruiting INTERVENTIONAL NCT06475352

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

Dihydropyrimidine Dehydrogenase (DPD) Phenotype-guided Dose Individualization of Fluoropyrimidine-based Chemotherapy in DPD Deficient Patients With Gastrointestinal Cancers

Sponsor: UNICANCER

Conditions Colorectal Cancer Digestive Cancer

Interventions CAPOX regimen FOLFOX regimen

Updated 6 times since 2024 Last updated: Apr 22, 2026 Started: Jan 20, 2025 Primary completion: Apr 1, 2027 Completion: Jan 1, 2030

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT06475352, this observational or N/A phase trial focuses on Colorectal Cancer and Digestive Cancer and remains actively recruiting participants. Sponsored by UNICANCER, it has been updated 6 times since 2025, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Study Description(click to expand)

Multicenter phase II trial evaluating different strategies of pre-specified fluoropyrimidine-dose adjustment according to \[U\] in DPD-deficient patients with gastrointestinal cancer.

Status Flow

Change History

6 versions recorded

Apr 28, 2026 — Present [daily]

Recruiting

Phase: PHASE2 → None
Sep 2025 — Apr 2026 [monthly]

Recruiting PHASE2
Feb 2025 — Sep 2025 [monthly]

Recruiting PHASE2

Status: Not Yet Recruiting → Recruiting
Dec 2024 — Feb 2025 [monthly]

Not Yet Recruiting PHASE2
Sep 2024 — Dec 2024 [monthly]

Not Yet Recruiting PHASE2

▶ Show 1 earlier version

Jul 2024 — Sep 2024 [monthly]

Not Yet Recruiting PHASE2

First recorded

Eligibility 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

Contact Information

Sponsor contact:

UNICANCER

Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Amiens, France , Aurillac, France , Avignon, France , Bayeux, France , Bayonne, France , Besançon, France , Caen, France , Caen, France , Caluire-et-Cuire, France , Clermont-Ferrand, France and 31 more locations