Bevacizumab, Radiotherapy and Temozolomide Safety study in biopsied or resected primary GBM patients

Phase 2

• Conditions: Glioblastoma Multiforme; Malignant brain tumor; 10029211

• Registration Number: NL-OMON31960
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Pending
• 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
3. Mini-Mental Status Score > 15
4. Karnofsky > 60
5. Adequate bone marrow function
6. Informed consent

Exclusion Criteria

1. Age < 18 years
2. Pregnancy
3. Reluctance to use contraceptives
4. Inability to comply with protocol or study procedures (for example, an inability to swallow tablets)
5. Bleeding disorders
6. Anti-coagulant therapy
7. Prior chemotherapy or radiotherapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main parameter is safety, as scored by the NCI Common Toxicity Criteria Scale. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Other classical response end-points (PFS6, Time to Treatment Failure, OS12 and<br /><br>OS) will be combined with quality of life questionnaires (MMSE, QLQ-C30 v3.0<br /><br>and EORTC BN-20) and compared to historical controls (Stupp data). All is<br /><br>monitored during the regularly scheduled outpatient clinic visits. The tumor<br /><br>MGMT status is determined in surgery specimens and will be used to study the<br /><br>predictive value for toxicity and clinical outcome. </p><br>