Informations générales (source: ClinicalTrials.gov)
Phase III Randomised Trial Evaluating Treatment Intensification With Temozolomide in Adults With a Glioblastoma
Interventional
Phase 3
Centre Oscar Lambret (Voir sur ClinicalTrials)
mars 2019
mai 2028
02 octobre 2025
Due to conflicting data on the optimal moment to start TMZ chemotherapy and the impact of
prolongation of the adjuvant phase with TMZ, the ANOCEF (Association des Neuro-Oncologues
d'Expression Francophone) group proposes this randomized trial comparing an intensified
arm (early TMZ and extended adjuvant TMZ until toxicity, progression or patient refusal)
versus the classical EORTC regimen as control (RT and concomitant TMZ started 4-6 weeks
after surgery followed by a number of adjuvant TMZ cycles strictly limited to 6) for
primary GBM adult patients.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL NOVO | AL SHEIKH Waad | 18/09/2025 17:50:12 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| USLD PITIE SALPETRIERE APHP | Khe HOANG XUAN, MD | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Jean Perrin - 63011 - Clermont-Ferrand 3024635 - France | Xavier DURANDO, MD | Contact (sur clinicalTrials) | |||
| Centre Léon Bérard - 69673 - Lyon 2996944 - France | Alice BONNEVILLE-LEVARD, MD | Contact (sur clinicalTrials) | |||
| Centre Paul Strauss - 67065 - Strasbourg 2973783 - France | Roland SCHOTT, MD | Contact (sur clinicalTrials) | |||
| CHU de Nice - Hôpital de Cimiez - 06000 - Nice 2990440 - France | Véronique BOURG, MD | Contact (sur clinicalTrials) | |||
| CHU Grenoble Alpes - 38043 - Grenoble 3014728 - France | Julien PAVILLET, MD | Contact (sur clinicalTrials) | |||
| Hôpitaux Civils de Colmar - 68024 - Colmar 3024297 - France | Guido AHLE, MD | Contact (sur clinicalTrials) | |||
| ICO Centre Paul Papin - 49055 - Angers 3037656 - France | Contact (sur clinicalTrials) | ||||
| Institut Cancérologie Loire - 42270 - Saint-Priest-en-Jarez 2977350 - France | Carole RAMIREZ, MD | 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 François Baclesse - 14076 - Caen 3029241 - France | Iona HRAB, MD | Contact (sur clinicalTrials) | |||
| Centre Georges François Leclerc - 21079 - Dijon 3021372 - France | François GHIRINGELLI, MD, PhD | Contact (sur clinicalTrials) | |||
| Centre Hospitalier d'Amiens - 80054 - Amiens 3037854 - France | BOONE Mathieu, MD, PhD | Contact (sur clinicalTrials) | |||
| CH René Dubos - 95300 - Pontoise 2986140 - France | Claudia RIZZO, MD | Contact (sur clinicalTrials) | |||
| CHRU Nancy - 54000 - Nancy 2990999 - France | Luc TAILLANDIER, MD | Contact (sur clinicalTrials) | |||
| CHRU Tours - 37044 - Tours 2972191 - France | Ilyess ZEMMOURA, MD | Contact (sur clinicalTrials) | |||
| CHU de Limoges - 87042 - Limoges 2998286 - France | Elise DELUCHE, MD | Contact (sur clinicalTrials) | |||
| CHU La Timone - 13385 - Marseille 2995469 - France | Olivier CHINOT, MD | Contact (sur clinicalTrials) | |||
| ICM Val d'Aurelle - 34298 - Montpellier 2992166 - France | Michel FABBRO, MD, PhD | Contact (sur clinicalTrials) | |||
| ICO Centre René Gauducheau - 44805 - Nantes 2990969 - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
- Patient ≥18 years old
- Histological diagnosis of de novo GBM (extemporaneous diagnosis or standard
pathological examination). In case of extemporaneous diagnosis, the patient can be
included. If the diagnosis is not confirmed, the patient will be withdrawn from
study.
- Time between initial surgery/biopsy and planned start of treatment (if allocated to
the experimental arm) ≤ 15 days (ideally in the first 7 days)
- Karnofsky performance status (KPS) ≥ 60%, or KPS <60% only related to glioma-related
motor paresis.
- Adequate biological functions
- Common toxicity criteria (CTC) non hematological adverse events ≤ Grade 1 (except
for alopecia, nausea, vomiting and neurological symptoms)
- Females of child bearing potential must have a negative serum or urine pregnancy
test within 7 days prior to initiation of treatment. Sexually active patients must
agree to use adequate and appropriate contraception while on study drug and for 6
months after stopping the study drug.
- Standard radiation therapy deemed feasible (60 Gy, 30 fractions)
- Time interval of less than 43 days between initial surgery/biopsy and planned start
of radiation therapy
- Written informed consent
Exclusion Criteria:
- Secondary or recurrent glioblastoma (GBM)
- Planned use of tumor-treating electric fields
- Planned use of Carmustine implants
- Prior malignancy in the last 5 years before inclusion or concomitant
- Severe myelosuppression
- Known hypersensitivity to any of the study drugs, study drug classes, excipients in
the formulation or to dacarbazine (DTIC)
- Current or recent treatment with another experimental drug or patients included in a
clinical therapeutic trial (in the 30 days prior to inclusion).
- Known current viral hepatitis, HIV infection or current active infectious disease
- Inability to swallow oral medications or any mal-absorption condition
- Pregnant or breastfeeding patients.
- Inability to comply with medical follow-up of the trial (geographical, social or
psychic reasons)
- Person under guardianship or curatorship