Treatment Intensification With Temozolomide in Adults With a Glioblastoma
Condition(s) studied
Investigational drug(s) / intervention(s)
Intensified protocol: Early Temozolomide (TMZ) 1 cycle (150 mg/m²/ day X 5 days, per os) Started between day 2 and 15 after surgery/ biopsy RT (60 Gy, 2 Gy/fraction) + concomitant TMZ (75 mg/m2/day X 42 days, per os) Started between W4 and W6 after surgery/ biopsy Adjuvant TMZ 6 cycles (150-200 mg/m2 X 5 days /month, per os) Started 1 month after the end of the concomitant TMZ Prolonged TMZ Until progression, intolerance, patient's or physician's decision (150-200 mg/m2 every 4 weeks, per os)
Stupp protocol: RT (60 Gy, 2 Gy/fraction) + concomitant Temozolomide (75 mg/m2/day X 42 days, per os) Started between W4 and W6 after surgery/ biopsy Adjuvant TMZ 6 cycles (150-200 mg/m2 X 5 days /month, per os) Started 1 month after the end of the concomitant TMZ
Study summary
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.
Eligibility
Primary outcome measure(s)
- Overall Survival (OS) — up to 18 months after recruitment of the last patient
time interval from randomization to death whatever the cause
Trial sites (17)
| Facility | City | Region | Status |
|---|---|---|---|
| Centre Hospitalier d'Amiens | Amiens | France | |
| Centre François Baclesse | Caen | France | |
| Centre Jean Perrin | Clermont-Ferrand | France | |
| Hôpitaux Civils de Colmar | Colmar | France | |
| Centre Georges François Leclerc | Dijon | France | |
| CHU Grenoble Alpes | Grenoble | France | |
| CHU de Limoges | Limoges | France | |
| Centre Léon Bérard | Lyon | France | |
| CHU La Timone | Marseille | France | |
| ICM Val d'Aurelle | Montpellier | France | |
| CHRU Nancy | Nancy | France | |
| CHU de Nice - Hôpital de Cimiez | Nice | France | |
| APHP La Pitié Salpêtrière | Paris | France | |
| CH René Dubos | Pontoise | France | |
| Institut Cancérologie Loire | Saint-Priest-en-Jarez | France | |
| Centre Paul Strauss | Strasbourg | France | |
| CHRU Tours | Tours | France |
More Centre Oscar Lambret trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03663725 on ClinicalTrials.gov ↗ ← All trials in France