Neoplasms

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Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

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Temozolomide

Early Temozolomide (TMZ) Concomitant TMZ Adjuvant TMZ Prolonged TMZ

Concomitant Temozolomide (TMZ) Adjuvant TMZ

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)

Intensified 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

Stupp protocol

Marie VANSEYMORTIER

BOONE Mathieu, MD, PhD

Alexandre COUTTE, MD

Etienne FESSART, MD

Christine DESENCLOS, MD

Mathieu BOONE, MD

Soraya RAMDANE, MD

Farid BELKHIR, MD

Iona HRAB, MD

Lien BEKAERT, MD

Julien GEFFRELOT, MD

Dinu STEFAN, MD

Evelyne EMERY, MD

David Hassanein BERRO, MD

Xavier DURANDO, MD

Maureen BERNADACH, MD

Guillaume DUPIC, MD

Toufic KHALIL, MD

Guido AHLE, MD

Claude GAULTIER, MD

David ATLANI, MD

Jimmy VOIRIN, MD

François GHIRINGELLI, MD, PhD

Julie VINCENT, MD

Jean-François GUION, MD

Gilles TRUC, MD

Walid FARAH, MD

Julien PAVILLET, MD

Coralie FRENOUX, MD

Emmanuel DE SCHLICHTING, MD

Elise DELUCHE, MD

François CAIRE, MD

Pierre CLAVERE, MD

Sandrine LAVAU-DENES, MD

Alice BONNEVILLE-LEVARD, MD

Didier FRAPPAZ, MD, PhD

Marie Pierre SUNYACH, MD

Coralie MONCHARMONT, MD

Ronan TANGUY, MD

Anne DURAND, MD

Olivier CHINOT, MD

Maryline BARRIE, MD

Chantal CAMPELLO, MD

Gregorio PETRIRENA, MD

Emeline TABOURET, MD

Xavier MURACCIOLE, MD

Henry DUFOUR, MD

Thomas GRAILLON, MD

Pierre Hugues ROCHE, MD

Michel FABBRO, MD, PhD

Marie CHASSIROUX, MD

Christine KERR, MD

Amélie DARLIX, MD

Luc BAUCHET, MD

Luc TAILLANDIER, MD

Patrick BEAUCHESNE, MD

Fabien RECH, MD

Guillaume VOGIN, MD

Véronique BOURG, MD

Christine LEBRUN-FRENAY, MD

Fabien ALMAIRAC, MD

Khe HOANG XUAN, MD

Ahmed IDBAIH, MD

Florence LAIGLE-DONADEY, MD

Agusti ALENTORN, MD

Caroline DEHAIS, MD

Caroline HOUILLIER, MD

Dimitri PSIMARAS, MD

Loïc FEUVRET, MD

Alexandre CARPENTIER, MD

Claudia RIZZO, MD

Denis NGUYEN, MD

Emmanuel MANDONNET, MD

Carole RAMIREZ, MD

Romain RIVOIRARD, MD

Jane Chloé TRONE, MD

Nicolas MAGNE, MD

François VASSAL, MD

Marie Jeannette MOTUO-FOTSO, MD

Roland SCHOTT, MD

Georges NOEL, MD, PhD

Hélène CEBULA, MD

Ilyess ZEMMOURA, MD

Christophe DESTRIEUX, MD

Bérengère NARCISO, MD

Sophie CHAPET, MD

Florence LEFRANC, MD

Bruno CHAUFFERT, MD

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.

Treatment Intensification With Temozolomide in Adults With a Glioblastoma

Phase III Randomised Trial Evaluating Treatment Intensification With Temozolomide in Adults With a Glioblastoma

time interval from randomization to death whatever the cause

from randomization until disease progression - reported and graded using the NCI-CTCAE v5.0 classification

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

Association de Neuro-Oncologues d'Expression Francaise

Erasme University Hospital

Centre Oscar Lambret

Spots Global Cancer Trial Database for intensified protocol