braintumor glioblastoma multiforme
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Patients with histologically confirmed newly diagnosed glioblastoma multiforme (World Health Organization [WHO] grade IV astrocytoma) with indication for radiotherapy and concomitant TMZ followed by adjuvant TMZ. • Patients must have clinically and radiographically documented measurable disease. Conventional MRI post surgery must be performed within 28 days prior to start of combined treatment. • Absence of inability to undergo MRI or PET scanning • Patients >18 years of age • WHO performance status of 2 or less • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial • Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
Exclusion criteria
Exclusion criteria: Are formulated as 'no existence of' in inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of FLT-PET treatment response defined as a more than 25% reduction in standardized uptake values (SUV) max at week 10 after start to MRI response at 22 and 34 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Correlation of FLT-PET response defined as a more than 25% reduction in standardized uptake values (SUV) max at week 10 after start radio/chemotherapy and OS at 6 months. | — |
Countries
Netherlands
Outcome results
None listed