Bevacizumab, Radiotherapy and Temozolomide Safety study in resected and irresectable primary GBM patients - BERTES

• Conditions: Primary Glioblastoma Multiforme; MedDRA version: 9.1Level: LLTClassification code 10018338Term: Glioma; MedDRA version: 9.1Level: LLTClassification code 10018336Term: Glioblastoma; MedDRA version: 9.1Level: LLTClassification code 10065443Term: Malignant glioma

• Registration Number: EUCTR2007-005644-24-NL
• Lead Sponsor: AMC-UvA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-31
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Age < 18 years
2. Pregnancy
3. Reluctance to use anti conceptional
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 clinical trial of medicinal product
• Study Design: Not specified