Informations générales (source: ClinicalTrials.gov)
Phase III Randomised Trial Evaluating Treatment Intensification With Temozolomide in Adults With a Glioblastoma (StrateGlio)
Interventional
Phase 3
Centre Oscar Lambret (Voir sur ClinicalTrials)
mars 2019
novembre 2027
29 juin 2024
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 | 04/07/2024 11:05:06 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| APHP La Pitié Salpêtrière - 75013 - Paris - France | Khe HOANG XUAN, MD | Contact (sur clinicalTrials) | |||
| Centre François Baclesse - 14076 - Caen - France | Iona HRAB, MD | Contact (sur clinicalTrials) | |||
| Centre Georges François Leclerc - 21079 - Dijon - France | François GHIRINGELLI, MD, PhD | Contact (sur clinicalTrials) | |||
| Centre Hospitalier d'Amiens - 80054 - Amiens - France | BOONE Mathieu, MD, PhD | Contact (sur clinicalTrials) | |||
| Centre Jean Perrin - 63011 - Clermont-Ferrand - France | Xavier DURANDO, MD | Contact (sur clinicalTrials) | |||
| Centre Léon Bérard - 69673 - Lyon - France | Alice BONNEVILLE-LEVARD, MD | Contact (sur clinicalTrials) | |||
| Centre Paul Strauss - 67065 - Strasbourg - France | Roland SCHOTT, MD | Contact (sur clinicalTrials) | |||
| CHRU Nancy - 54000 - Nancy - France | Luc TAILLANDIER, MD | Contact (sur clinicalTrials) | |||
| CHRU Tours - 37044 - Tours - France | Ilyess ZEMMOURA, MD | Contact (sur clinicalTrials) | |||
| CHU de Limoges - 87042 - Limoges - France | Elise DELUCHE, MD | Contact (sur clinicalTrials) | |||
| CHU de Nice - Hôpital de Cimiez - 06000 - Nice - France | Véronique BOURG, MD | Contact (sur clinicalTrials) | |||
| CHU Grenoble Alpes - 38043 - Grenoble - France | Julien PAVILLET, MD | Contact (sur clinicalTrials) | |||
| CHU La Timone - 13385 - Marseille - France | Olivier CHINOT, MD | Contact (sur clinicalTrials) | |||
| Hôpitaux Civils de Colmar - 68024 - Colmar - France | Guido AHLE, MD | Contact (sur clinicalTrials) | |||
| ICM Val d'Aurelle - 34298 - Montpellier - France | Michel FABBRO, MD, PhD | Contact (sur clinicalTrials) | |||
| ICO Centre Paul Papin - 49055 - Angers - France | Contact (sur clinicalTrials) | ||||
| ICO Centre René Gauducheau - 44805 - Nantes - France | Contact (sur clinicalTrials) | ||||
| Institut Cancérologie Loire - 42270 - Saint-Priest-en-Jarez - France | Carole RAMIREZ, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- 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
- 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
- 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