Actively Recruiting
Bevacizumab Versus Corticosteroids as First-line Treatment in Patients With 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
262 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
Cerebral radiation necrosis (CRN) is a severe complication of high-dose radiation for brain metastases (BM) or glioma, which can potentially cause significant neurologic symptoms leading to serious morbidity and impaired quality of life (QoL). The first-line therapy for symptomatic CRN (sCRN) is corticosteroids, primarily dexamethasone, which often leads to complications, refractory symptoms, and interference with anti-cancer treatment. Since 2017, bevacizumab, an antibody against Vascular Endothelial Growth Factor (VEGF), has been used in a second-line treatment setting for refractory sCRN. A small randomized clinical trial (RCT) has shown that bevacizumab significantly diminishes cerebral edema on MRI and decreases clinical symptoms of sCRN in irradiated glioma patients. Several non-randomized clinical studies demonstrated a beneficial radiological and clinical effect of bevacizumab in patients with sCRN after irradiation for BM. The optimal first-line treatment for sCRN is currently unknown. Effective and safe first-line treatment of sCRN will optimize the patient's well-being and health-related QoL. Furthermore, minimizing corticosteroid use will benefit the clinical treatment options and outcomes of concomitant or future anti-cancer treatment. This phase III multicenter, open-label, randomized clinical trial compares the clinical efficacy of first-line bevacizumab versus standard-of-care dexamethasone for sCRN in patients with high-grade glioma (HGG) or BM.
CONDITIONS
Official 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 completion of focal (re-)irradiation
- Diagnosis confirmed by local Neuro-Oncology Board with no tumor progression
- Karnofsky Performance Score (KPS) of 90 or lower and minimum loss of two points in at least one domain of the NANO scale due to cerebral radiation necrosis
- Maximum daily dexamethasone use of 1 mg/day for 8 weeks before randomization (except in the week before randomization if used for cerebral radiation necrosis)
- Ability to understand patient information, online tests, and questionnaires
- Provided written informed consent
- For brain metastases patients: diagnosis of solid tumor brain metastases
- For high-grade glioma patients: confirmed histological diagnosis according to WHO 2021 criteria including specific glioma subtypes
You will not qualify if you...
- Prior bevacizumab treatment 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 medication administration, including intolerance or allergy to study drugs
- Nephrotic syndrome or abnormal kidney function with creatinine clearance below 30 mL/min or significant proteinuria
- Significant cardiovascular disease such as uncontrolled hypertension despite treatment, recent vascular events, heart failure NYHA II-IV
- History of gastrointestinal fistula, perforation, or abscess within 6 months
- Recent bleeding events including pulmonary hemorrhage, gastrointestinal bleeding, or recent intracranial hemorrhage
- Increased risk of bleeding due to inherited conditions or low platelet count below 75x10^9/L
- Risk of wound healing complications including recent major surgery or trauma within 28 days or minor procedures within 7 days before treatment
- Previous, current, or planned high dose abdominal radiotherapy
- Pregnancy or lactation without negative pregnancy test and required contraception
- Other medical or psychiatric conditions interfering with treatment or compliance
- Participation in another investigational drug study within 30 days before treatment
AI-Screening
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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
CONTACT
D
Dieta Brandsma, MD, PhD
CONTACT
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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