Brain metastases (BM), High grade glioma (HGG)
Conditions
Brief summary
a favourable clinical response, which is defined as (a) utilization of 1.5mg/day or less dexamethasone and (b) meeting one of the following two criteria: 1) improved Karnofsky Performance Status (KPS) (≥ 10 points ) + at least stable Neurologic Assessment in Neuro-Oncology (NANO) or 2) improved NANO (≥ 2 points) + at least stable KPS, assessed 12 weeks after initiation of treatment.
Detailed description
improvement of ≥10 points on the EORTC QLQ C30 physical functioning (and other clinically relevant functioning and symptom scales) at 12 weeks, reduction of cerebral edema on T2/Fluid Attenuated Inversion Recovery (FLAIR) and contrast-enhancing lesion on Based on CCMO protocol template CTR Version 3.0, May 2023 14 of 103 T1 MRI at 12 weeks, change in cognitive functioning measured by the Amsterdam Cognition Scan (ACS) at 12 weeks, experienced epileptic seizure frequency and antiseizure medication use at 12 weeks, number of treatment related adverse events until 21 days post end of treatment, 2-year sCRN recurrence free survival, time to next anti-CRN treatment, 2-year progression free survival, 2-year overall survival, the cost-effectiveness of both treatments, the number of patients who reached the main endpoint between 2 and 4 cycles of bevacizumab
Interventions
DRUGDEXAMETHASONE
DRUGBEVACIZUMAB
Sponsors
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a favourable clinical response, which is defined as (a) utilization of 1.5mg/day or less dexamethasone and (b) meeting one of the following two criteria: 1) improved Karnofsky Performance Status (KPS) (≥ 10 points ) + at least stable Neurologic Assessment in Neuro-Oncology (NANO) or 2) improved NANO (≥ 2 points) + at least stable KPS, assessed 12 weeks after initiation of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| improvement of ≥10 points on the EORTC QLQ C30 physical functioning (and other clinically relevant functioning and symptom scales) at 12 weeks, reduction of cerebral edema on T2/Fluid Attenuated Inversion Recovery (FLAIR) and contrast-enhancing lesion on Based on CCMO protocol template CTR Version 3.0, May 2023 14 of 103 T1 MRI at 12 weeks, change in cognitive functioning measured by the Amsterdam Cognition Scan (ACS) at 12 weeks, experienced epileptic seizure frequency and antiseizure medication use at 12 weeks, number of treatment related adverse events until 21 days post end of treatment, 2-year sCRN recurrence free survival, time to next anti-CRN treatment, 2-year progression free survival, 2-year overall survival, the cost-effectiveness of both treatments, the number of patients who reached the main endpoint between 2 and 4 cycles of bevacizumab | — |
Countries
Netherlands
Outcome results
None listed