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ACTIVE NOT RECRUITING
NCT03663725
PHASE3

Treatment Intensification With Temozolomide in Adults With a Glioblastoma

Sponsor: Centre Oscar Lambret

View on ClinicalTrials.gov

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

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

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