No registrations found.
ID
Source
Brief title
Health condition
1. Primary Glioblastoma Multiforme (NLD: primair Glioblastoma multiforme),;
2. bevacizumab;
3. temozolomide (NLD:radiotherapie).
Sponsors and support
Academisch Medisch Centrum
Meibergdreef 15
1105 AZ Amsterdam
+31 20 5669111
Intervention
Outcome measures
Primary outcome
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
Secondary objectives: determination of:
1. efficacy;
2. classical response end-points;
3. tumor imaging biomarkers;
4. tissue samples biomarkers.
Background summary
Median 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.
Study objective
Hypothesis 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.
Study design
N/A
Intervention
Study 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).
Meibergdreef 15
W.R. Furth van
Amsterdam 1105 AZ
The Netherlands
+31 20 5669111
w.r.vanfurth@amc.uva.nl
Meibergdreef 15
W.R. Furth van
Amsterdam 1105 AZ
The Netherlands
+31 20 5669111
w.r.vanfurth@amc.uva.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1113 |
| NTR-old | NTR1148 |
| CCMO | NL20411.018.07 |
| ISRCTN | ISRCTN wordt niet aangevraagd/Observational study |
| OMON | NL-OMON31960 |