drugset / Trial / NCT03663725
Treatment Intensification With Temozolomide in Adults With a Glioblastoma
Phase 3
Active not recruiting
486 enrolled
Centre Oscar Lambret
Association de Neuro-Oncologues d'Expression Francaise · collabErasme University Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2019-03-13
- Primary completion
- 2027-06
- Completion
- 2027-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Temozolomide | Small molecule | 75 mg/m2 | Oral |
| Subject | Temozolomide | Small molecule | 150 mg/m2 | Oral |
| Subject | Temozolomide | Small molecule | 200 mg/m2 | Oral |