Actively Recruiting
Bevacizumab Versus Corticosteroids as First-line Treatment for Symptomatic Cerebral Radiation Necrosis After Radiation for High-grade Glioma or Brain Metastases
Led by The Netherlands Cancer Institute · Updated on 2026-02-25
408
Participants Needed
5
Research Sites
104 weeks
Total Duration
On this page
Sponsors
T
The Netherlands Cancer Institute
Lead Sponsor
U
UMC Utrecht
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating first-line treatments for symptomatic cerebral radiation necrosis (sCRN), a serious complication following high-dose radiation therapy for brain metastases or high-grade glioma, which can cause severe neurological symptoms and reduce quality of life. This phase III multicenter, open-label, randomized clinical trial compares bevacizumab, an antibody targeting VEGF, to the standard corticosteroid dexamethasone to assess their effectiveness and safety as initial treatments for sCRN. Participants will be randomly assigned to one of two treatment groups. One group receives intravenous bevacizumab at a fixed dose of 600 mg every three weeks for four doses over 12 weeks. The other group receives daily oral dexamethasone with a tapering dose over 12 weeks. Patients on bevacizumab may also use dexamethasone if medically necessary. After completing the 12-week treatment, patients will be followed for two years. During the study, participants will have regular hospital visits including brain MRI scans, cognitive testing with the Amsterdam Cognition Scan, and complete questionnaires on quality of life, epilepsy, productivity, and medical costs. Optional blood samples may be collected for research. The main outcome measured is clinical efficacy at 12 weeks, defined by reduced dexamethasone use combined with improved neurological and performance scores. Safety, quality of life, cognitive function, seizure control, tumor progression, survival, and cost-effectiveness will also be monitored throughout the two-year follow-up.
CONDITIONS
Brief Title
Bevacizumab Versus Corticosteroids as First-line Treatment in Patients With Symptomatic Cerebral Radiation Necrosis After Radiation for High-grade Glioma or Brain Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- First episode of symptomatic cerebral radiation necrosis at least 3 months after completing focal radiation therapy
- Karnofsky Performance Status score of 90 or less and a minimum loss of two points in at least one domain of the Neurologic Assessment in Neuro-Oncology scale due to sCRN
- Maximum daily dexamethasone use of 1 mg/day for the 8 weeks before randomization, except for higher doses during the week before randomization if used specifically for sCRN
- Able to understand patient information, online tests, and questionnaires
- Provided written informed consent
- For brain metastases: diagnosis of brain metastases from any solid tumor
- For high-grade glioma: confirmed histological diagnosis according to WHO 2021 criteria including specific glioma types
You will not qualify if you...
- Prior treatment with bevacizumab within 6 months before diagnosis of symptomatic cerebral radiation necrosis
- Life expectancy less than 3 months
- Signs of brain herniation requiring immediate decompressive surgery
- Any condition preventing safe use of study medications such as intolerance or allergy to bevacizumab or dexamethasone, nephrotic syndrome or severe kidney impairment, significant cardiovascular disease, recent vascular events or bleeding, high risk of bleeding, wound healing complications, recent major surgery or trauma, high dose abdominal radiotherapy
- Pregnancy or breastfeeding; women of childbearing potential must have a negative pregnancy test and use contraception
- Other medical or psychiatric conditions affecting study participation or safety
- Recent use of another investigational drug or participation in another interventional study within 30 days
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants receive either intravenous bevacizumab every three weeks for four courses over 12 weeks or daily oral dexamethasone with a tapering dose over 12 weeks as first-line treatment for symptomatic cerebral radiation necrosis.
Regular inpatient hospital visits and scheduled MRI brain scans during treatment
Duration - Up to 2 years
Participants are monitored for up to 2 years after treatment to assess quality of life, clinical efficacy, seizure control, toxicity, recurrence, tumor progression, survival, and other long-term outcomes.
Regular follow-up visits including questionnaires and optional blood withdrawals
Trial Site Locations
Total: 5 locations
1
Netherlands Cancer Institute - Antoni van Leeuwenhoek
Amsterdam, Netherlands, 1066 CX Amsterdam
Actively Recruiting
2
Amsterdam University Medical Centers, location VUmc and AMC
Amsterdam, Netherlands
Actively Recruiting
3
Leiden University Medical Center
Leiden, Netherlands, 2333 ZA Leiden
Actively Recruiting
4
Haaglanden Medical Center
The Hague, Netherlands, 2262 BA Leidschendam
Actively Recruiting
5
University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX Utrecht
Actively Recruiting
Research Team
D
Danique Laan, MSc
D
Dieta Brandsma, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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