brain tumor glioblastoma
Conditions
Interventions
The investigational arm will be treated with hypofractionated radiotherapy 6
Gy, in 6 fractions per week, combined with daily temozolomide, followed by
adjuvant temozolomide. The control arm receive
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Histological diagnosis of GBM with any MGMT-promotor methylation status and IDH1 mutation status by multidisciplinary neuro-oncology tumor board. • Age >= 18 years. • KPS >=70. • Surgical biopsy or resection performed. • Decision of chemoradiation following the Stupp-protocol by multidisciplinary neuro-oncology tumour board.
Exclusion criteria
Exclusion criteria: • Participation in a competing trial. • Prior overlapping intracranial radiotherapy. • Known carcinoma 6cm (~ reflecting a spherical tumor volume of 125 cc). • Unwilling or unable to undergo MRI scans. • Contra-indication for gadolinium contrast. • Women with childbearing potential without adequate contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is overall survival. | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary endpoints are HRQoL (through questionnaires), cost-effectiveness, progression-free survival, both clinical and radiological toxicity and edema treatment | — |
Countries
Netherlands
Outcome results
None listed