Phase II study of 18 F fluorothymidine Positron Emission Tomography (FLT-PET) in the follow up of glioblastoma multiforme (GBM) patients treated with combined radiotherapie and chemotherapy

Phase 2

Completed

Conditions: braintumor
glioblastoma multiforme
10029211

Registration Number: NL-OMON38320

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

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

Are formulated as 'no existence of' in inclusion criteria

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Comparison of FLT-PET treatment response defined as a more than 25% reduction<br /><br>in standardized uptake values (SUV) max at week 10 after start to MRI response<br /><br>at 22 and 34 weeks.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Correlation of FLT-PET response defined as a more than 25% reduction in<br /><br>standardized uptake values (SUV) max at week 10 after start radio/chemotherapy<br /><br>and OS at 6 months.</p><br>