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.
ID
Bron
Verkorte titel
Aandoening
1. Primary Glioblastoma Multiforme (NLD: primair Glioblastoma multiforme),;
2. bevacizumab;
3. temozolomide (NLD:radiotherapie).
Ondersteuning
Academisch Medisch Centrum
Meibergdreef 15
1105 AZ Amsterdam
+31 20 5669111
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Primary objective is determination of safety of combination of standard treatment with 3 bevacizumab infusions, followed by the standard adjuvant cycles of temozolomide.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
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).
Algemeen / deelnemers
Meibergdreef 15
W.R. Furth van
Amsterdam 1105 AZ
The Netherlands
+31 20 5669111
w.r.vanfurth@amc.uva.nl
Wetenschappers
Meibergdreef 15
W.R. Furth van
Amsterdam 1105 AZ
The Netherlands
+31 20 5669111
w.r.vanfurth@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL1113 |
NTR-old | NTR1148 |
CCMO | NL20411.018.07 |
ISRCTN | ISRCTN wordt niet aangevraagd/Observational study |
OMON | NL-OMON31960 |