Informations générales (source: ClinicalTrials.gov)
Dihydropyrimidine Dehydrogenase (DPD) Phenotype-guided Dose Individualization of Fluoropyrimidine-based Chemotherapy in DPD Deficient Patients With Gastrointestinal Cancers (FUDOSE)
Interventional
Phase 2
UNICANCER (Voir sur ClinicalTrials)
janvier 2025
janvier 2030
05 avril 2025
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
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 10/04/2025 13:12:05 | Contact (sur clinicalTrials) | |||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Beaujon | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Saint Antoine | Contact (sur clinicalTrials) | ||||
| CLCC INSTITUT GUSTAVE ROUSSY | Contact (sur clinicalTrials) | ||||
| GRPE HOSP DIACONESSES-CROIX ST-SIMON | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Antoine Lacassagne - 06189 - Nice - France | Contact (sur clinicalTrials) | ||||
| Centre François Baclesse - 14000 - Caen - France | Contact (sur clinicalTrials) | ||||
| Centre Léon Bérard - 69373 - Lyon - France | Contact (sur clinicalTrials) | ||||
| CH Aunay Bayeux - 14400 - Bayeux - France | Contact (sur clinicalTrials) | ||||
| CH Cote Basque - 64109 - Bayonne - France | Contact (sur clinicalTrials) | ||||
| CH de Saint Malo - 35403 - Saint-Malo - France | Contact (sur clinicalTrials) | ||||
| CHU Amiens - 50054 - Amiens - France | Contact (sur clinicalTrials) | ||||
| CHU Besançon - 25000 - Besançon - France | Contact (sur clinicalTrials) | ||||
| CHU Bordeaux - 33600 - Pessac - France | Contact (sur clinicalTrials) | ||||
| CHU Clermont Ferrand - 63003 - Clermont-Ferrand - France | Contact (sur clinicalTrials) | ||||
| CHU de Toulouse - 31059 - Toulouse - France | Contact (sur clinicalTrials) | ||||
| CHU Dijon - 21079 - Dijon - France | Contact (sur clinicalTrials) | ||||
| CHU d'Orléans - 45067 - Orléans - France | Contact (sur clinicalTrials) | ||||
| CHU Dupuytren - 87042 - Limoges - France | Contact (sur clinicalTrials) | ||||
| CHU Poitiers - 86000 - Poitiers - France | Contact (sur clinicalTrials) | ||||
| GH Mutualiste de Grenoble - 38028 - Grenoble - France | Contact (sur clinicalTrials) | ||||
| Grand Hopital de l'Est Francilien - 77100 - Meaux - France | Contact (sur clinicalTrials) | ||||
| Hopital Bretonneau - 37044 - Tours - France | Contact (sur clinicalTrials) | ||||
| Hopital Nord Franche Comté - Site du Mittan - 25200 - Montbéliard - France | Contact (sur clinicalTrials) | ||||
| Hopital Privé Drome-Ardeche - 07500 - Guilherand-Granges - France | Contact (sur clinicalTrials) | ||||
| Hopital Privé Jean Mermoz - 69008 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Hopital Robert Debré - 51100 - Reims - France | Contact (sur clinicalTrials) | ||||
| Hopital Saint Louis - 75010 - Paris - France | Contact (sur clinicalTrials) | ||||
| Hospices Civiles de Lyon - 69495 - Pierre-Bénite - France | Contact (sur clinicalTrials) | ||||
| Institut du Cancer Avignon Provence - 84000 - Avignon - France | Contact (sur clinicalTrials) | ||||
| Institut du Cancer de Strasbourg - 67033 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Institut Jean Godinot - 51100 - Reims - France | Contact (sur clinicalTrials) | ||||
| Polyclinique du Parc - Centre d'Oncologie Maurice Tubiana - 14000 - Caen - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
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.
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.
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.