Treatment Intensification With Temozolomide in Adults With a Glioblastoma

PHASE3RecruitingINTERVENTIONAL
Enrollment

486

Participants

Timeline

Start Date

March 13, 2019

Primary Completion Date

February 28, 2027

Study Completion Date

May 1, 2028

Conditions
Glioblastoma
Interventions
DRUG

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)

DRUG

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

Trial Locations (19)

13385

RECRUITING

CHU La Timone, Marseille

14076

RECRUITING

Centre François Baclesse, Caen

21079

RECRUITING

Centre Georges François Leclerc, Dijon

34298

RECRUITING

ICM Val d'Aurelle, Montpellier

37044

RECRUITING

CHRU Tours, Tours

38043

RECRUITING

CHU Grenoble Alpes, Grenoble

42270

RECRUITING

Institut Cancérologie Loire, Saint-Priest-en-Jarez

44805

WITHDRAWN

ICO Centre René Gauducheau, Nantes

49055

WITHDRAWN

ICO Centre Paul Papin, Angers

54000

RECRUITING

CHRU Nancy, Nancy

63011

RECRUITING

Centre Jean Perrin, Clermont-Ferrand

67065

RECRUITING

Centre Paul Strauss, Strasbourg

68024

RECRUITING

Hôpitaux Civils de Colmar, Colmar

69673

RECRUITING

Centre Léon Bérard, Lyon

75013

RECRUITING

APHP La Pitié Salpêtrière, Paris

80054

RECRUITING

Centre Hospitalier d'Amiens, Amiens

87042

RECRUITING

CHU de Limoges, Limoges

95300

RECRUITING

CH René Dubos, Pontoise

06000

RECRUITING

CHU de Nice - Hôpital de Cimiez, Nice

All Listed Sponsors
collaborator

Association de Neuro-Oncologues d'Expression Francaise

OTHER

collaborator

Erasme University Hospital

OTHER

lead

Centre Oscar Lambret

OTHER