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Observational study;
Bevacizumab, Radiotherapy and Temozolomide Safety study in resected and irresectable primary GBM patients.



- candidate number2852
- NTR NumberNTR1148
- ISRCTNISRCTN wordt niet aangevraagd/Observational study
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-nov-2007
- Secondary IDsNL20411.018.07 Mec. nr
- Public TitleObservational study;
Bevacizumab, Radiotherapy and Temozolomide Safety study in resected and irresectable primary GBM patients.
- Scientific TitleObservational study;
Bevacizumab, Radiotherapy and Temozolomide Safety study in biopsied or resected primary GBM patients.
- ACRONYMBERTES-01
- hypothesisHypothesis in this trial is safe enhancement of the efficacy of chemoradiotherapy in resected and irresectable primary GBM patients, by using the anti-edema effect of bevacizumab and its vascular normalization response.
- Healt Condition(s) or Problem(s) studiedPrimary glioblastoma multiforme
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-dec-2007
- planned closingdate1-dec-2010
- Target number of participants20
- InterventionsStudy population will be treated with standard GBM chemoradiotherapy schedule plus additional 3 infusions of the angiogenesis inhibitor bevacizumab at a dose of 10 mg/kg during irradiation (e.g. one dose every 2 weeks during 6 weeks radiotherapy).
- Primary outcomePrimary objective is determination of safety of combination of standard treatment with 3 bevacizumab infusions, followed by the standard adjuvant cycles of temozolomide.
- Secondary outcomeSecondary objectives: determination of:
1. efficacy;
2. classical response end-points;
3. tumor imaging biomarkers;
4. tissue samples biomarkers.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMD PhD W.R. Furth van
- CONTACT for SCIENTIFIC QUERIESMD PhD W.R. Furth van
- Sponsor/Initiator Academic Medical Centre (AMC)Departments of Neurosurgery, Radiation Oncology, Clinical Oncology and Neurology
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryMedian survival for patients with a newly diagnosed GBM is 12.1 months after resection of the tumor to the maximum extent, followed by 60 Gy irradiation in 30 x 2 Gy fractions. Maximal surgical resection is not feasible in a sub-group of patients due to the localization of their tumor, resulting in poorer prognosis. In a selected group of patients the median survival was 14.6 months when resection was followed by radiotherapy in combination with temozolomide during and thereafter temozolomide 6 monthly cycles. Chemoradiotherapy with temozolomide is the current standard treatment for GBM in our center. New combination treatments are required to lengthen survival of GBM patients. This trial utilizes the anti-edema effect of bevacizumab and its vascular normalization response to enhance the efficacy of chemoradiotherapy in resected and irresectable primary GBM patients.
- Main changes (audit trail)
- RECORD1-nov-2007 - 13-sep-2009


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