Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06475352

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  1. Patients with pre-treatment screening based on [U] value according to INCa/HAS recommendations.

  2. Eastern Cooperative Oncology Group performance status (ECOG PS) ≤2

  3. 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
  4. Age ≥ 18 years

  5. Patients eligible for full standard fluoropyrimidine and oxaliplatin doses regardless of DPD deficiency

  6. 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

  7. 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.

  8. Women of childbearing potential must have a negative serum or urine pregnancy test.

  9. 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.

  10. Patients must be affiliated to a Social Security System (or equivalent).

  11. 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.

Not Eligible

You will not qualify if you...

  1. Patients with complete DPD deficiency based on [U] ≥150 ng/mL
  2. Any prior treatment including a fluoropyrimidine
  3. Patients with any contraindication to treatment with fluoropyrimidine or oxaliplatin regardless of DPD deficiency
  4. Patients not eligible for full standard dose fluoropyrimidine and oxaliplatin for clinical reasons including older age and/or comorbidity regardless of a DPD deficiency
  5. 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
  6. Recent or concomitant treatment with brivudine
  7. Pregnant or breastfeeding woman.
  8. Participation in another therapeutic trial within 30 days prior to inclusion.
  9. 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

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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

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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

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