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Compares treatment options for Radiation Necrosis
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
ClinicalTrials.gov ID: NCT06888817
What this study is testing
What is Bevacizumab?
Bevacizumab is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for radiation necrosis.
Also referred to as Avastin, Anti-VEGF monoclonal antibody.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 12 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Inclusion all patients (both HGG and BM):
- Age ≥ 18 years old
- First episode of sCRN ≥ 3 months after completion of focal (re-)irradiation, as determined by the local Multidisciplinary Neuro-Oncology Board. A...
- KPS score ≤ 90 and either (a) a minimum loss of two points in at least one domain of the Neurologic Assessment in Neuro-Oncology (NANO) scale as...
- Maximum daily dexamethasone use of 1 mg/day for the 8 weeks preceding randomization
You likely can't join if
- A potential subject who meets any of the following criteria will be excluded from participation in this study, both for the BM and HGG group:
- Prior treatment with bevacizumab \<6 months before diagnosis of sCRN
- Life expectancy \<3 months
- Impending radiological or clinical signs of brain herniation necessitating immediate decompressive surgery
- Any comorbidity or condition that prevents safe administration of the studied medication, determined by the treating physician, including but not...
- Intolerance for murine proteins
See the full eligibility criteria
- Inclusion all patients (both HGG and BM):
- Age ≥ 18 years old
- First episode of sCRN ≥ 3 months after completion of focal (re-)irradiation, as determined by the local Multidisciplinary Neuro-Oncology Board. A clear working diagnosis of CRN without evidence of a combination with...
- KPS score ≤ 90 and either (a) a minimum loss of two points in at least one domain of the Neurologic Assessment in Neuro-Oncology (NANO) scale as compared to the maximum score of that domain due to sCRN, or (b) a...
- Maximum daily dexamethasone use of 1 mg/day for the 8 weeks preceding randomization
- Dexamethasone may have been prescribed for various indications, except for managing (ongoing) cerebral edema
- Higher doses of dexamethasone are permitted 3 weeks immediately preceding randomization if used specifically for the treatment of sCRN
- Able to understand the patient information, online tests and questionnaires
- Written informed consent Inclusion BM: 1\. BM of solid tumour, including all primary tumour types Inclusion HGG: 1\. A confirmed histological diagnosis of high-grade diffuse glioma according to WHO 2021 criteria...
- A potential subject who meets any of the following criteria will be excluded from participation in this study, both for the BM and HGG group:
- Prior treatment with bevacizumab \<6 months before diagnosis of sCRN
- Life expectancy \<3 months
- Impending radiological or clinical signs of brain herniation necessitating immediate decompressive surgery
- Any comorbidity or condition that prevents safe administration of the studied medication, determined by the treating physician, including but not limited to:
- Intolerance for murine proteins
- Hypersensitivity or allergy to the active substance or to any of the excipients of bevacizumab or dexamethasone
- Nephrotic syndrome or abnormal renal function o Calculated (Cockcroft-Gault) or measured creatinine clearance \<30 mL/min; urine dipstick for proteinuria ≥ 2+. Patients with ≥ 2+ proteinuria on dipstick urinalysis at...
- Clinical significant cardiovascular disease
- Uncontrolled hypertension (systolic BP \>150mmHg and/or diastolic \>100mmHg) despite the use of ≥ 3 antihypertensive drugs
- Previous hypertensive crisis, hypertensive encephalopathy or previous reversible posterior leukoencephalopathy syndrome (RPLS)
- Non tumour related vascular event (e.g. cerebral or cardiac ischemia/bleeding (including transient ischemic attack, cerebral ischemia, unstable angina or angina requiring intervention, myocardial infarction), peripheral...
- History of aortic aneurysm or dissection
- Congestive heart failure NYHA II-IV
- History of gastro-intestinal fistula, perforation or abscess \< 6 months
- History of bleeding
- Relevant pulmonary hemorrhage/ hemoptysis \< 1 month or the presence of a pulmonary lesion with a high risk of bleeding (= central lung tumour and/or untreated squamous cell carcinoma) according to the treating physician
- Active gastrointestinal bleeding \< 6 months
- Evidence of recent intracranial hemorrhage on MRI brain \<3 months. Asymptomatic presence of hemosiderin depositions or punctate hemorrhage in the tumour do not serve as a ground for exclusion
- Excess risk of bleeding
- History or evidence of inherited bleeding diathesis or significant coagulopathy with the risk of bleeding
- Decreased platelet count \< 75x109/L
- Risk of wound healing complications
- Significant non-healing wound, (peptic) ulcer or bone fracture
- Major surgical procedure (including open biopsy) or significant traumatic injury within 28 days prior to first study treatment or planned surgical procedure within the following next 28 days after planned study inclusion
- Minor surgical procedure, stereotactic/core biopsy, fine needle aspiration within 7 days prior to first study treatment
- High-dose radiotherapy to the mediastinum, abdomen, or lower pelvis; administration of bevacizumab should only be considered after prior consultation with a pulmonologist or oncologist
- Pregnancy or lactation. Women of child bearing potential (WOCBP) must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 7 days prior to randomization. WOCBP and female...
- Evidence of any other medical conditions (such as psychiatric illness, physical examination or laboratory findings) that may interfere with the study treatment, affect patient compliance or place the patient at high...
- Current or recent (within 30 days of first study treatment) treatment with another investigational drug or participation in another treatment study In case of uncertainty, consult the principal investigator of the study...
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, Netherlands
- Leiden, Netherlands
- Maastricht, Netherlands
- The Hague, Netherlands
- Utrecht, Netherlands
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, Netherlands; Leiden, Netherlands; Maastricht, Netherlands; The Hague, Netherlands; Utrecht, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.