Braintumor (GBM)
Conditions
Interventions
To assess the ability of FLT-PET to discriminate between pseudo progression and true
progression as measured by MRI at 10 and 22 weeks in patients with newly diagnosed
GBM treated with concomitant and
Sponsors
UMCGroningen
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with histologically confirmed newly diagnosed glioblastoma multiforme (World Health Organization [WHO] grade IV astrocytoma) with indication and eligibility 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; 2. Absence of inability to undergo MRI or PET scanning; 3. Patients >18 years of age; 4. WHO performance status of 2 or less; 5. 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; 6. Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
Exclusion criteria
Exclusion criteria: 1. Patients with no histologically confirmed newly diagnosed glioblastoma multiforme (World Health Organization [WHO] grade IV astrocytoma) or without indication and eligibility for radiotherapy and concomitant TMZ followed by adjuvant TMZ. No conventional MRI post surgery; 2. Inability to undergo MRI or PET scanning; 3. Patients <18 years of age; 4. WHO performance status of 3; 5. 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; 6. No written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of FLT-PET response defined as a more than 25% reduction in standardized uptake values (SUV) max (see section 7) at week 10 after start temozolomide/radiotherapy to MRI response at 22 weeks between pseudo progression and true progression. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Correlation of FLT-PET response defined as a more than 25% reduction in standardized uptake values (SUV) max (see section 7) at week 10 after start temozolomide/radiotherapy and OS at 6 and 12 months; 2. Correlation of Ki-67 proliferation index on tumor obtained by immunohistochemical staining with FLT ƒ¢SUV max uptake. | — |
Contacts
Public ContactA.M.E. Walenkamp
Hanzeplein 1
Outcome results
None listed