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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
486
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)
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
Centre Hospitalier d'Amiens
Amiens, France
Centre François Baclesse
Caen, France
Centre Jean Perrin
Clermont-Ferrand, France
Overall Survival (OS)
time interval from randomization to death whatever the cause
Time frame: up to 18 months after recruitment of the last patient
Number of adverse events
from randomization until disease progression - reported and graded using the NCI-CTCAE v5.0 classification
Time frame: up to 18 months after recruitment of the last patient
Progression-free survival
time interval from randomization to the first occurrence of progression according to RANO criteria as assessed by the treating physician, or death whatever the cause
Time frame: up to 18 months after recruitment of the last patient
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 7 more locations