Actively Recruiting
Dose Individualization of Chemotherapy in Patients With Gastrointestinal Cancers Lacking a Specific Liver Enzyme
Led by UNICANCER · Updated on 2026-04-23
400
Participants Needed
41
Research Sites
258 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Dose Individualization of Chemotherapy in Patients With Gastrointestinal Cancers Lacking a Specific Liver Enzyme
Who Can Participate
Eligibility Criteria
You may qualify if you...
-
Patients with pre-treatment screening based on [U] value according to INCa/HAS recommendations.
-
Eastern Cooperative Oncology Group performance status (ECOG PS) ≤2
-
Fluoropyrimidine-naïve patients with gastrointestinal cancer starting chemotherapy combining fluoropyrimidine (5-FU or capecitabine) and oxaliplatin whatever the context (adjuvant, neoadjuvant, palliative) including the following regimens (the most frequently prescribed in gastrointestinal cancers):
- biweekly 5-FU and oxaliplatin (FOLFOX) +/- targeted therapy (TT)
- three-weekly capecitabine and oxaliplatin (CAPOX) +/- TT
-
Age ≥ 18 years
-
Patients eligible for full standard fluoropyrimidine and oxaliplatin doses regardless of DPD deficiency
-
Adequate bone marrow function (cell blood count (CBC)), estimated glomerular filtration rate (DFG) ≥ 50 ml/min, alkaline phosphatase (ALP) / aspartate aminotransferase (ASAT) / alanine aminotransferase (ALAT) ≤ 5 upper limit of normal (ULN), and bilirubin ≤ 50 micromol/L
-
Patient must have signed and dated a written informed consent form prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent.
-
Women of childbearing potential must have a negative serum or urine pregnancy test.
-
Patients must agree to remain abstinent or use contraceptive methods with a failure rate of < 1% per year for the duration of study treatment and within 6 months after completing treatment.
-
Patients must be affiliated to a Social Security System (or equivalent).
-
Patient is willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up.
You will not qualify if you...
- Patients with complete DPD deficiency based on [U] ≥150 ng/mL
- Any prior treatment including a fluoropyrimidine
- Patients with any contraindication to treatment with fluoropyrimidine or oxaliplatin regardless of DPD deficiency
- Patients not eligible for full standard dose fluoropyrimidine and oxaliplatin for clinical reasons including older age and/or comorbidity regardless of a DPD deficiency
- Patients unwilling or unable to comply with trial obligations for geographic, social, or physical reasons, or who are unable to understand the purpose and procedures of the trial
- Recent or concomitant treatment with brivudine
- Pregnant or breastfeeding woman.
- Participation in another therapeutic trial within 30 days prior to inclusion.
- Persons deprived of their liberty or under protective custody or guardianship.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 41 locations
1
CHU Amiens
Amiens, France, 50054
Actively Recruiting
2
Hopital Henri Mondor
Aurillac, France
Actively Recruiting
3
Institut du Cancer Avignon Provence
Avignon, France, 84000
Actively Recruiting
4
CH Aunay Bayeux
Bayeux, France, 14400
Actively Recruiting
5
CH Cote Basque
Bayonne, France, 64109
Actively Recruiting
6
CHU Besançon
Besançon, France, 25000
Actively Recruiting
7
Centre François Baclesse
Caen, France, 14000
Actively Recruiting
8
Polyclinique du Parc - Centre d'Oncologie Maurice Tubiana
Caen, France, 14000
Actively Recruiting
9
Infirmerie Protestante
Caluire-et-Cuire, France
Not Yet Recruiting
10
CHU Clermont Ferrand
Clermont-Ferrand, France, 63003
Not Yet Recruiting
11
Hopital Beaujon
Clichy, France, 92110
Actively Recruiting
12
Hopital Henri Mondor
Créteil, France, 94010
Actively Recruiting
13
CHU Dijon
Dijon, France, 21079
Actively Recruiting
14
GH Mutualiste de Grenoble
Grenoble, France, 38028
Actively Recruiting
15
Hopital Privé Drome-Ardeche
Guilherand-Granges, France, 07500
Actively Recruiting
16
Centre Oscar Lambret
Lille, France
Actively Recruiting
17
CHU Dupuytren
Limoges, France, 87042
Actively Recruiting
18
Hopital Privé Jean Mermoz
Lyon, France, 69008
Actively Recruiting
19
Centre Léon Bérard
Lyon, France, 69373
Actively Recruiting
20
Grand Hopital de l'Est Francilien
Meaux, France, 77100
Actively Recruiting
21
Hopital Nord Franche Comté - Site du Mittan
Montbéliard, France, 25200
Actively Recruiting
22
Centre Antoine Lacassagne
Nice, France, 06189
Actively Recruiting
23
CHU d'Orléans
Orléans, France, 45067
Actively Recruiting
24
Institut Curie
Paris, France, 75005
Actively Recruiting
25
Hopital Saint Louis
Paris, France, 75010
Actively Recruiting
26
Hopital Saint Antoine
Paris, France, 75012
Actively Recruiting
27
GH Diaconesses Croix St Simon
Paris, France, 75020
Actively Recruiting
28
Hopital Européen Georges Pompidou
Paris, France
Actively Recruiting
29
CHU Bordeaux
Pessac, France, 33600
Actively Recruiting
30
Hospices Civiles de Lyon
Pierre-Bénite, France, 69495
Actively Recruiting
31
CHU Poitiers
Poitiers, France, 86000
Actively Recruiting
32
Hopital Robert Debré
Reims, France, 51100
Actively Recruiting
33
Institut Jean Godinot
Reims, France, 51100
Withdrawn
34
Centre Eugene Marquis
Rennes, France
Not Yet Recruiting
35
CHU Rouen - Hopital Charles Nicoles
Rouen, France
Actively Recruiting
36
CH de Saint Malo
St-Malo, France, 35403
Actively Recruiting
37
Institut du Cancer de Strasbourg
Strasbourg, France, 67033
Actively Recruiting
38
CHU de Toulouse
Toulouse, France, 31059
Actively Recruiting
39
Hopital Bretonneau
Tours, France, 37044
Actively Recruiting
40
CHRU Nancy
Vandœuvre-lès-Nancy, France
Not Yet Recruiting
41
Gustave Roussy Cancer Campus
Villejuif, France, 94805
Actively Recruiting
Research Team
N
Nicolas DE SOUSA CARVALHO
CONTACT
L
Laure MONARD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here