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Digestive CancerPhase 2FUDOSENCT06475352

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

A Phase 2 study testing FOLFOX regimen and CAPOX regimen in people with Digestive Cancer and Colorectal Cancer, run by UNICANCER at 41 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Digestive Cancer, Colorectal Cancer
What is being tested?
FOLFOX regimen and CAPOX regimen
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
41 sitesFrance
Study dates
20 Jan 2025to Jan 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • 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.

Trial locations and contacts

41 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Nicolas DE SOUSA CARVALHO contact

01 71 93 67 09

n-de-sousa@unicancer.fr

Laure MONARD contact

01 73 79 73 09

l-monard@unicancer.fr

41 sites in 1 country

France41 sites, 40 recruiting

  • CHU Amiens

    Amiens, 50054

    Vincent HAUTEFEUILLE, Dr.

    Recruiting

  • Hopital Henri Mondor

    Aurillac

    Daniela BURLACU

    Recruiting

  • Institut du Cancer Avignon Provence

    Avignon, 84000

    Clémence TOULLEC, Dr.

    Recruiting

  • CH Aunay Bayeux

    Bayeux, 14400

    Annie PEYTIER, Dr.

    Recruiting

  • CH Cote Basque

    Bayonne, 64109

    Franck AUDEMAR, Dr.

    Recruiting

  • CHU Besançon

    Besançon, 25000

    Angélique VIENOT, Dr.

    Recruiting

  • Centre François Baclesse

    Caen, 14000

    Stéphane CORBINAIS, Dr.

    Recruiting

  • Polyclinique du Parc - Centre d'Oncologie Maurice Tubiana

    Caen, 14000

    Maud VILLEMIN, Dr.

    Recruiting

  • Infirmerie Protestante

    Caluire-et-Cuire

    Emmanuelle GRAILLOT

    Not yet recruiting

  • CHU Clermont Ferrand

    Clermont-Ferrand, 63003

    Morgane HELYON, Dr.

    Not yet recruiting

  • Hopital Beaujon

    Clichy, 92110

    Mohamed BOUATTOUR, Dr.

    Recruiting

  • Hopital Henri Mondor

    Créteil, 94010

    Charlotte FENIOUX, Dr.

    Recruiting

  • CHU Dijon

    Dijon, 21079

    Come LEPAGE, Dr.

    Recruiting

  • GH Mutualiste de Grenoble

    Grenoble, 38028

    Camille HERVE, Dr.

    Recruiting

  • Hopital Privé Drome-Ardeche

    Guilherand-Granges, 07500

    Agnes PELAQUIER, Dr.

    Recruiting

  • Centre Oscar Lambret

    Lille

    Aurélien Dr CARNOT

    Recruiting

  • CHU Dupuytren

    Limoges, 87042

    Frédéric THUILLIER, Dr.

    Recruiting

  • Hopital Privé Jean Mermoz

    Lyon, 69008

    Jérome DESRAME, Dr.

    Recruiting

  • Centre Léon Bérard

    Lyon, 69373

    Clelia COUTZAC, Dr.

    Recruiting

  • Grand Hopital de l'Est Francilien

    Meaux, 77100

    Christophe LOCHER, Dr

    Recruiting

  • Hopital Nord Franche Comté - Site du Mittan

    Montbéliard, 25200

    Christophe BORG, Dr.

    Recruiting

  • Centre Antoine Lacassagne

    Nice, 06189

    Claire JARAUDIAS, Dr.

    Recruiting

  • CHU d'Orléans

    Orléans, 45067

    Jean-Paul LAGASSE, Dr.

    Recruiting

  • Institut Curie

    Paris, 75005

    Pauline VAFLARD, Dr.

    Recruiting

  • Hopital Saint Louis

    Paris, 75010

    Thomas APARICIO, Pr.

    Recruiting

  • Hopital Saint Antoine

    Paris, 75012

    Daniel LOPEZ TRABADA ATAZ, Dr.

    Recruiting

  • GH Diaconesses Croix St Simon

    Paris, 75020

    Olivier DUBREUIL, Dr.

    Recruiting

  • Hopital Européen Georges Pompidou

    Paris

    Aziz Pr ZAANAN

    Recruiting

  • CHU Bordeaux

    Pessac, 33600

    Denis SMITH, Dr.

    Recruiting

  • Hospices Civiles de Lyon

    Pierre-Bénite, 69495

    Marion CHAUVENET, Dr.

    Recruiting

  • CHU Poitiers

    Poitiers, 86000

    David TOUGERON, Pr.

    Recruiting

  • Hopital Robert Debré

    Reims, 51100

    Olivier BOUCHE, Pr.

    Recruiting

  • Institut Jean Godinot

    Reims, 51100

    Withdrawn

  • Centre Eugene Marquis

    Rennes

    Astrid LIEVRE

    Not yet recruiting

  • CHU Rouen - Hopital Charles Nicoles

    Rouen

    Adrien Dr GRANCHER

    Recruiting

  • CH de Saint Malo

    St-Malo, 35403

    Anne-Sophie MOUSSADDAQ, Dr.

    Recruiting

  • Institut du Cancer de Strasbourg

    Strasbourg, 67033

    Meher BEN ABDELGHANI, Dr.

    Recruiting

  • CHU de Toulouse

    Toulouse, 31059

    Nadim FARES, Dr.

    Recruiting

  • Hopital Bretonneau

    Tours, 37044

    Thierry LECOMTE, Pr.

    Recruiting

  • CHRU Nancy

    Vandœuvre-lès-Nancy

    Marie MULLER

    Not yet recruiting

  • Gustave Roussy Cancer Campus

    Villejuif, 94805

    Valérie BOIGE, Dr.

    Recruiting

Other trials in France

About this study

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

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
Read the detailed description

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

Being tested
FOLFOX regimen, CAPOX regimen
Keywords
Fluoropyrimidine, FOLFOX, CAPOX, Adjuvant, Metastatic, Recurrent, Colorectal, digestive, Cancer
Medical subject headings
Gastrointestinal Neoplasms, Colorectal Neoplasms, Neoplasm Metastasis, Recurrence, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FOLFOX regimenDrug

    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)

  • CAPOX regimenDrug

    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

Study groups in NCT06475352
Study groupRoleWhat they receive
Uracilemia <16Active comparatorPatient with uracilemia <16 ng/mL will receive a full standard fluoropyrimidine dose
Receives: Drug: FOLFOX regimen; Drug: CAPOX regimen
Uracilemia [16-20[ExperimentalPatients with uracilemia between [16-20[ ng/mL will receive a full standard fluoropyrimidine dose -dose
Receives: Drug: FOLFOX regimen; Drug: CAPOX regimen
Uracilemia [20-50[ - 25%ExperimentalPatients with uracilemia between [20-50[ ng/mL will be randomized to receive a 25% fluoropyrimidine dose reduction
Receives: Drug: FOLFOX regimen; Drug: CAPOX regimen
Uracilemia [20-50[ - 50%ExperimentalPatients with uracilemia between [20-50[ ng/mL will be randomized to receive a 50% fluoropyrimidine dose reduction
Receives: Drug: FOLFOX regimen; Drug: CAPOX regimen
Uracilemia [50-100[ExperimentalPatients with uracilemia between [50-100[ ng/mL will receive a 50% fluoropyrimidine dose reduction
Receives: Drug: FOLFOX regimen; Drug: CAPOX regimen
Uracilemia [100-150[ExperimentalPatients with uracilemia between [100-150[ ng/mL will receive a 75% fluoropyrimidine dose reduction
Receives: Drug: FOLFOX regimen; Drug: CAPOX regimen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of fluoropyrimidine-induced grade ≥ 3 haematological and gastrointestinal toxicity after 2 cycles

    The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders.

    Measured: Throughout the two first cycles of treatment, up to 42 days

Secondary outcomes (7)

  1. Recommended fluoropyrimidine dose

    The rate of fluoropyrimidine induced grade ≥ 3 haematological and gastrointestinal toxicity in each uracilemia-based group of DPD-deficient patients (according to uracilemia level) compared to the rate observed in non DPD-deficient patients (control arm)

    Measured: Throughout the four first cycles of treatment, up to 3 months

  2. Description of fluoropyrimidine dose

    The cumulative dose (mg/m²) of chemotherapy delivered to patients will be recorded along with reasons of dose-modifications or treatment discontinuation for limiting toxicity

    Measured: Throughout the four first cycles of treatment, up to 3 months

  3. Percentage of fluoropyrimidine dose modification

    Percentage of patients for whom fluoropyrimidine dose is increased or decreased

    Measured: Throughout the four first cycles of treatment, up to 3 months

  4. Fluoropyrimidine toxicity during the study

    The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders.

    Measured: Throughout the four first cycles of treatment, up to 3 months

  5. Disease-free survival (DFS) - Stage III Colon Cancer

    Disease-free survival is defined as the delay between date of inclusion and tumor relapse (local, regional, or distant) or death from any cause, whichever occurs first.

    Measured: 3 years

  6. Overall survival (OS) - Stage III Colon Cancer

    The overall survival is the length of time from randomization that patients enrolled in the study are still alive.

    Measured: From randomization to death from any cause, up to 3 years.

  7. Progression-free survival (PFS) - Stage IV Colon Cancer

    The progression-free survival is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse.

    Measured: From randomization to disease progression or death, up to 1 year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2024
  2. Study start20 Jan 2025
  3. Primary completionApr 2027 (estimated)
  4. Study completionJan 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06475352
Sponsor's protocol ID
UC-GIG-2311
Other IDs
2023-509963-25-00, 2023
Acronym
FUDOSE
Status last verified
Mar 2026
First submitted
20 Jun 2024
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

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.

    PubMed 42173726

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FOLFOX regimen and CAPOX regimen in people with Digestive Cancer and Colorectal Cancer, run by UNICANCER at 41 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nicolas DE SOUSA CARVALHO (01 71 93 67 09, n-de-sousa@unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of fluoropyrimidine-induced grade ≥ 3 haematological and gastrointestinal toxicity after 2 cycles (time frame: Throughout the two first cycles of treatment, up to 42 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06475352, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.

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