Clinical trial • Phase IV • Oncology|Neurology

Temozolomide for Brain stem glioma|Malignant glioma

Phase IV trial of Temozolomide for Brain stem glioma|Malignant glioma. 60 participants.

Overview

Trial Therapeutic Area
Oncology|Neurology
Trial Disease
Brain stem glioma|Malignant glioma
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
07-06-2024
First CTIS Authorization Date
01-08-2024

Trial design

Phase IV trial across 24 sites in France.

Target Sample Size
60

Eligibility

Recruits 60 No vulnerable populations selected; trial population is adults..

Vulnerable Population
No vulnerable populations selected; trial population is adults.

Recruitment

Planned Sample Size
60
Recruitment Window Months
90

Geography

Total Number Of Sites
24
Total Number Of Participants
60

France

Earliest CTIS Part Ii Submission Date
13-06-2024
Latest Decision Or Authorization Date
08-10-2025
Processing Time Days
482
Number Of Sites
24
Number Of Participants
60

Sites

Site Name
ICANS - Institut de cancérologie Strasbourg Europe
Department Name
RADIOTHÉRAPIE | RADIOISOTOPES | RADIOLOGIE | RADIOPHYSIQUE
Contact Person Name
Georges Noël
Contact Person Email
g.noel@icans.eu
Site Name
CHRU De Nancy
Department Name
Neuro-oncologie
Contact Person Name
Marie Blonski
Contact Person Email
m.blonski@chru-nancy.fr
Site Name
Hospital Foch
Department Name
Neuroscience
Contact Person Name
Nadia Younan
Contact Person Email
n.younan@hopital-foch.com
Site Name
CHRU de Brest - Hôpital de la cavale Blanche
Department Name
Neurochirurgie
Contact Person Name
Elsa Magro
Contact Person Email
elsa.magro@chu-brest.fr
Site Name
Centre Henri Becquerel
Department Name
Oncologie Médicale
Contact Person Name
Isabelle Tennevet
Site Name
CHU Saint Etienne Hôpital Nord
Department Name
NEUROLOGIE
Contact Person Name
Carole Ramirez
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Oncologie Médicale
Contact Person Name
Tiffany Farbas
Contact Person Email
Tiffany.DARBAS@chu-limoges.fr
Site Name
Institut Gustave Roussy
Department Name
Onco-radiologie
Contact Person Name
Frédéric Dhermain
Site Name
Hospices Civils de LYON - Hôpital Pierre Wertheimer
Department Name
Neuro-oncologie
Contact Person Name
François Ducray
Contact Person Email
francois.ducray@chu-lyon.fr
Site Name
Institut Regional Du Cancer De Montpellier
Department Name
Oncologie Médicale
Contact Person Name
Michel Fabbro
Contact Person Email
michel.fabbro@icm.unicancer.fr
Site Name
CHU de Nice- Hôpital Pasteur 2
Department Name
NEUROLOGIE
Contact Person Name
Véronique Bourg
Contact Person Email
bourg.v@chu-nice.fr
Site Name
Centre De Recherche En Cancerologie De Lyon
Department Name
Oncologie Médicale
Contact Person Name
Alice Bonneville-Levard
Contact Person Email
LEVARD@lyon.unicancer.fr
Site Name
Hôpitaux Universitaires de Marseille Timone
Department Name
Neuro-oncologie
Contact Person Name
Olivier Chinot
Contact Person Email
Olivier.CHINOT@ap-hm.fr
Site Name
Centre Hospitalier De Colmar
Department Name
NEUROLOGIE
Contact Person Name
Guido Ahle
Contact Person Email
guido.ahle@ch-colmar.fr
Site Name
CHU Amiens - Groupe Hospitalier Sud
Department Name
Oncologie Médicale et Neurologie
Contact Person Name
Mathieu Boone
Contact Person Email
boone.mathieu@chu-amiens.fr
Site Name
CHU Saint Eloi
Department Name
Neurochirurgie
Contact Person Name
Luc Bauchet
Contact Person Email
l-bauchet@chu-montpellier.fr
Site Name
Centre Hospitalier Universitaire Rouen
Department Name
Neurochirurgie
Contact Person Name
Olivier Langlois
Contact Person Email
Olivier.langlois@chu-rouen.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Oncologie Médicale
Contact Person Name
Benjamin Auberger
Contact Person Email
benjamin.auberger@chu-brest.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Neuro-onclologie
Contact Person Name
Apolline Monfilliette
Contact Person Email
Apolline.DJELAD@CHRU-LILLE.FR
Site Name
CHU Grenoble Alpes - Hôpital Michallon
Department Name
Oncologie médicale
Contact Person Name
Julien Pavillet
Contact Person Email
jpavillet@chu-grenoble.fr
Site Name
Institut de Cancérologie de l'Ouest - site d'Angers
Department Name
Oncologie Médicale
Contact Person Name
Pierre Kubicek
Site Name
Assistance Publique Hopitaux De Paris
Department Name
NEUROLOGIE
Contact Person Name
Florence Laigle-Donadey
Site Name
CHU Rennes - Hôpital Pontchaillou- Centre Eugène Marquis
Department Name
Oncologie Médicale
Contact Person Name
Elodie Vauleon
Contact Person Email
e.vauleon@rennes.unicancer.fr
Site Name
Centre de Coordination en Cancérologie François Baclesse
Department Name
Neur-onclologie
Contact Person Name
Ioana HRAB
Contact Person Email
i.hrab@baclesse.unicancer.fr

Sponsor

Primary sponsor

Full Name
Assistance Publique Hopitaux De Paris
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
Temozolomide
Active Substance
Temozolomide
Modality
Small molecule

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