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Набира участници Фаза 2 NCT06475352

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

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Digestive Cancer Colorectal Cancer

Спонсор: UNICANCER

Налично на: БГ
Обобщение
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
Описание
Multicenter phase II trial evaluating different strategies of pre-specified fluoropyrimidine-dose adjustment according to \[U\] in DPD-deficient patients with gastrointestinal cancer.
Кой може да участва
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. Exclusion Criteria: 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.
Интервенции
FOLFOX regimen
DRUG
CAPOX regimen
DRUG
Места на провеждане 41
Франция (41)
CHU Amiens
Amiens
Hopital Henri Mondor
Aurillac
Institut du Cancer Avignon Provence
Avignon
CH Aunay Bayeux
Bayeux
CH Cote Basque
Bayonne
CHU Besançon
Besançon
Centre François Baclesse
Caen
Polyclinique du Parc - Centre d'Oncologie Maurice Tubiana
Caen
Infirmerie Protestante
Caluire-et-Cuire
NOT_YET_RECRUITING
CHU Clermont Ferrand
Clermont-Ferrand
NOT_YET_RECRUITING
Hopital Beaujon
Clichy
Hopital Henri Mondor
Créteil
CHU Dijon
Dijon
GH Mutualiste de Grenoble
Grenoble
Hopital Privé Drome-Ardeche
Guilherand-Granges
Centre Oscar Lambret
Lille
CHU Dupuytren
Limoges
Hopital Privé Jean Mermoz
Lyon
Centre Léon Bérard
Lyon
Grand Hopital de l'Est Francilien
Meaux
Hopital Nord Franche Comté - Site du Mittan
Montbéliard
Centre Antoine Lacassagne
Nice
CHU d'Orléans
Orléans
Institut Curie
Paris
Hopital Saint Louis
Paris
Hopital Saint Antoine
Paris
GH Diaconesses Croix St Simon
Paris
Hopital Européen Georges Pompidou
Paris
CHU Bordeaux
Pessac
Hospices Civiles de Lyon
Pierre-Bénite
CHU Poitiers
Poitiers
Hopital Robert Debré
Reims
Institut Jean Godinot
Reims
WITHDRAWN
Centre Eugene Marquis
Rennes
NOT_YET_RECRUITING
CHU Rouen - Hopital Charles Nicoles
Rouen
CH de Saint Malo
St-Malo
Institut du Cancer de Strasbourg
Strasbourg
CHU de Toulouse
Toulouse
Hopital Bretonneau
Tours
CHRU Nancy
Vandœuvre-lès-Nancy
NOT_YET_RECRUITING
Gustave Roussy Cancer Campus
Villejuif
Технически детайли
Статус
Набира участници
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
20.01.2025
Крайна дата
01.01.2030
Регистрационен номер
NCT06475352
Източник
clinicaltrials.gov
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