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Treatment Intensification With Temozolomide in Adults With a Glioblastoma
Sponsor: Centre Oscar Lambret
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.
Official title: Phase III Randomised Trial Evaluating Treatment Intensification With Temozolomide in Adults With a Glioblastoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
486
Start Date
2019-03-13
Completion Date
2027-06
Last Updated
2026-03-30
Healthy Volunteers
No
Conditions
Interventions
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
Locations (17)
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