Observational study;Bevacizumab, Radiotherapy and Temozolomide Safety study in resected and irresectable primary GBM patients.
Completed
- Conditions
- 1. Primary Glioblastoma Multiforme (NLD: primair Glioblastoma multiforme),<br />2. bevacizumab<br />3. temozolomide (NLD:radiotherapie).
- Registration Number
- NL-OMON27467
- Lead Sponsor
- Departments of Neurosurgery, Radiation Oncology, Clinical Oncology and NeurologyAcademisch Medisch CentrumMeibergdreef 151105 AZ Amsterdam+31 20 5669111
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
1. Patients with histologically proven GBM (biopsy or resection);
2. Can start 3-8 weeks post biopsy or surgery;
Exclusion Criteria
1. Age <18 years;
2. Pregnancy;
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary objective is determination of safety of combination of standard treatment with 3 bevacizumab infusions, followed by the standard adjuvant cycles of temozolomide.
- Secondary Outcome Measures
Name Time Method Secondary objectives: determination of:<br /> <br>1. efficacy;<br /><br>2. classical response end-points;<br /> <br>3. tumor imaging biomarkers;<br /> <br>4. tissue samples biomarkers.