Etude : VEFORA /



ATTENTION : pour chaque essai clinique, les éléments affichés ci-dessous ne sont pas exhaustifs, et le protocole fourni par le promoteur reste l’unique document à consulter pour mener à bien un essai clinique sur centre. Pour plus d'informations, contactez le référent du territoire concerné.


Acronyme
Nom
Traitement
Dernière MÀJ
Présentation de l'étude
Acronyme : VEFORA

Nom :

Traitement : Métastasique ou localement avancé

Dernière MÀJ : 26/09/2017
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Etude de phase II/III randomisée multicentrique d‘évaluation d‘une chimiothérapie par Cisplatine fractionné/Gemcitabine ou Carboplatine/Gemcitabine dans une population de patients porteurs d'un cancer urothélial avancé ou métastatique dont la fonction rénale est altérée

Spécialité : Voies urinaires
Localisation : C.8 - Toutes localisations : voies urinaires

Spécialité : Voies urinaires
Localisation : C67 - Tumeur maligne de la vessie
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : Randomized, Multicenter, Phase II/III Study, Evaluating Fractionated Cisplatin Chemotherapy/Gemcitabine Versus Carboplatin/Gemcitabine in the Treatment of Advanced or Metastatic Urothelial Cancer With Impaired Renal Function.

2 arms:
- Active Comparator: Carboplatin/Gemcitabine
Carboplatin AUC (area under curve) 4,5 at day 1 of each cycle until 6 cycles.
Gemcitabine 1000mg/m² at day 1 and day 8 of each cycle until 6 cycles.
- Experimental: Fractionated Cisplatin/Gemcitabine
Cisplatin 35mg/m² at day 1 and day 8 of each cycle until 6 cycles.
Gemcitabine 1000mg/m² at day 1 and day 8 of each cycle until 6 cycles.

Phase : II/III

Stade : NA

1
Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : . Age < or = 18 years, patients aged 75 years or more will benefit from a geriatric assessment.
. Advanced or metastatic urothelial cancer confirmed histologically or cytologically.
. Patients liable to receive a first -line chemotherapy for advanced or metastatic urothelial carcinoma.
. Measurable disease according to RECIST criteria V1.1.
. Patients who received neoadjuvant or adjuvant chemotherapy based on platinum salt must have completed treatment at least 6 months before entering the study.
. Performance status < or = 2.
. Life expectancy > 3 months.
. Patients with creatinine clearance between 40 and 60 ml / min ( according to Cockcroft and Gault ).
. Patients having no contra-indication to overhydration.
. Satisfactory hematological tests: Neutrophils > 1.5 G / l Platelets > 150 G / l , hemoglobin ≥ 10 g / dl.
. Satisfactory liver function tests: total bilirubin < 1.5 x ULN (upper limit of normal), AST (aspartate aminotransferase) and ALT (alanine aminotransferase)

Critères de non-inclusion : . Any concomitant or previous malignancy within 5 years prior to the study ( with the exception of basal cell or squamous cell carcinoma in situ).
. Pregnant or lactating women.
. Patients with brain metastases or meningeal or symptoms suggestive of such secondary locations.
. Bisphosphonate or Denosumab treatment initiated within 28 days prior to randomization into the study or patient who have started such treatment during the study ( a bisphosphonate or denosumab treatment initiated within a period longer than 28 days before randomization may be continued without change during the study ).
. Other concomitant cancer (radiation therapy, radiopharmaceutical agent chemotherapy).
. Patients with uncontrolled infection.
. Patients with peripheral neuropathy grade> 1, whatever the origin or patients with hearing loss.
. Patient with unstable disease (eg: unstable diabetes, poorly controlled hypertension , congestive heart failure or myocardial infarction within 3 months prior to study entry).
. Known hypersensitivity to study drugs.
. Treatment with any other investigational drug within 30 days before inclusion.
. Any psychological condition , familial, sociological or geographical not to comply with medical monitoring and / or procedures in the study protocol.
. Patient protected by law.
NCT
Promoteur
Contact ARC
Coordonnateur
Informations relatives au promoteur
NCT :
Promoteur :
Institut Claudius Regaud
Type de sponsor : Institutionnel
31100 TOULOUSE

Contact ARC :

Coordonnateur :
Loïc MOUREY
mourey.loic@claudiusregaud.fr
0561424548
Centre investigateur
Investigateur
TEC / ARC / IDE
État
Type d'étude
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre François BACLESSE - 3 avenue du Général Harris - 14000 CAEN

Investigateur :
Emmanuel SEVIN

TEC / ARC / IDE :
Jérémy BOUTROIS
j.boutrois@
baclesse.unicancer.fr

Ouverture de l'essai : CLOS

Type d'étude : Hors ciblage moléculaire / Hors innovation thérapeutique
MAJ : 11/07/2018