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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-005644-24-NL
Enrollment
Unknown
Registered
2007-10-31
Start date
2007-11-27
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Glioblastoma Multiforme MedDRA version: 9.1 Level: LLT Classification code 10018338 Term: Glioma MedDRA version: 9.1 Level: LLT Classification code 10018336 Term: Glioblastoma MedDRA version: 9.1 Level: LLT Classification code 10065443 Term: Malignant glioma

Interventions

Trade Name: Avastin Pharmaceutical Form: Intravenous infusion Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Unknown use (Noncurrent)

Sponsors

AMC-UvA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Main Objective: Primary objective is determination of safety of combination of standard treatment with 3 bevacizumab infusions, followed by the standard adjuvant cycles of temozolomide. ;Secondary Objective: Secondary objectives: determination of: efficacy, classical response end-points, tumor imaging biomarkers and tissue samples biomarkers.;Primary end point(s): Safety of the combination of the standard post resection chemoradiotherapy protocol with 3 bevacizumab 10 mg/kg infusions during chemoradiation, as measured by the NCI Common Toxicity Criteria Scale and compared to historical controls, until completion of treatment, typically 6 months after start of irradiation.—

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026