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Evaluation of Bevacizumab in Patients with Brain Radionecrosis After Radiation Treatment for Brain Metastases

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with brain radionecrosis, a condition where brain tissue is damaged following radiation therapy for brain metastases. The study aims to determine if adding bevacizumab to standard treatment with corticosteroids is more effective than using corticosteroids with placebo in treating symptoms of brain radionecrosis.

The treatment involves a combination of medications including prednisolone tablets (a corticosteroid medication), sodium chloride solution for infusion, and bevacizumab (also known as Avastin) given through an intravenous infusion. The study medication or placebo will be given along with standard corticosteroid therapy for three months.

During the study, doctors will monitor how well the treatment works by measuring changes in corticosteroid dose requirements and evaluating neurological symptoms. They will also track changes in the brain using medical imaging and assess the patient's quality of life. The total duration of monitoring after treatment will continue for up to two years to observe long-term effects of the treatment.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    On the first day (C1D1), your current condition and medication needs will be assessed, including the dose of corticosteroids you are taking

    You will complete quality of life questionnaires called EORTC QLQ-C30 and BN20

    Your neurological function will be evaluated using a special assessment called NANO score

  2. Step 2

    Treatment cycles

    You will receive either bevacizumab or placebo through an intravenous infusion

    You will continue taking prednisolone tablets as prescribed

    Treatment is organized in 4 cycles over 3 months (90 days)

    At the start of each cycle (C1D1, C2D1, C3D1, C4D1), your neurological function will be assessed

    Quality of life questionnaires will be completed at the beginning of each cycle

  3. Step 3

    End of treatment evaluation

    After 90 days, a final evaluation will be conducted

    Your corticosteroid dose will be assessed

    A brain MRI scan will be performed

    You will complete the final set of quality of life questionnaires

    Your neurological function will be evaluated one last time

  4. Step 4

    Follow-up period

    Your condition will be monitored every 3 months for up to 2 years

    During follow-up visits, your neurological function will be assessed

    Your corticosteroid medication dose will be tracked

    Side effects will be monitored using standard criteria

Who can join the trial?

14 criteria

  • Patient must have a diagnosis of radionecrosis (tissue damage from radiation) confirmed by MRI and nuclear medicine imaging following brain radiation therapy
  • Patient must have persistent or worsening symptoms despite taking corticosteroids (anti-inflammatory medications) at a dose of at least 1 mg/kg/day of prednisolone or equivalent for at least 2 weeks
  • Must have received last brain radiation treatment at least 3 months ago
  • Must be at least 18 years old
  • Must have adequate physical functioning with an ECOG score of 2 or less, or Karnofsky score of 50 or higher (scales that measure patient's ability to perform daily activities)
  • Must have a life expectancy of at least 3 months
  • Must not have previously received bevacizumab treatment for radionecrosis
  • Must have adequate organ function including:
    • Healthy blood cell counts
    • Normal blood clotting function
    • Good kidney function
    • Normal liver function
    • Women who can become pregnant must use effective birth control during treatment and for 6 months after
    • Must provide signed informed consent
    • Must be affiliated with a social security scheme

Who cannot join the trial?

16 criteria

  • Age below 18 years old or above 65 years old
  • Pregnant or breastfeeding women
  • Active bleeding or high risk of bleeding
  • History of serious allergic reactions to bevacizumab (the study medication)
  • Uncontrolled hypertension (high blood pressure)
  • Major surgery within the last 28 days
  • Unhealed wounds or ulcers
  • Serious heart conditions including:
    • Unstable angina (chest pain)
    • Heart attack within the last 6 months
    • Severe heart failure
    • Active infections requiring treatment
    • Participation in other clinical trials within the last 30 days
    • Inability to follow study procedures or attend follow-up visits
    • Known hypersensitivity to corticosteroids
    • Severe kidney or liver dysfunction
    • Current use of blood thinning medications that cannot be safely discontinued
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Investigated drugs

  • Bevacizumab

    is a medication that helps reduce abnormal blood vessel growth and swelling in the brain. It is commonly used to treat various types of cancers and their complications. In this trial, it is being studied for its potential to help patients who have developed tissue damage in the brain (radionecrosis) after receiving radiation therapy for brain metastases.

  • Corticosteroids

    are medications that reduce inflammation and swelling in the body. They are commonly used to treat many conditions, including brain swelling. In this trial, they are being used as a standard treatment for patients who have developed tissue damage in the brain after radiation therapy.

What is already known about the treatment

  • Bevacizumab

    A targeted therapy medication administered through intravenous infusion that works by blocking the formation of new blood vessels in tumors. This monoclonal antibody is primarily used in the treatment of brain radionecrosis following radiation therapy for brain metastases, where it helps reduce swelling and tissue damage caused by radiation treatment. Bevacizumab functions by binding to and inhibiting vascular endothelial growth factor (VEGF), a protein that stimulates blood vessel formation, and belongs to the class of anti-angiogenic agents. The medication has shown promise in allowing patients to reduce their dependence on corticosteroids while managing neurological symptoms associated with radiation-induced brain tissue damage.

  • Corticosteroids

    A class of steroid medications typically administered orally or intravenously that are used as standard therapy for managing brain radionecrosis and its associated inflammation. These medications work by suppressing the immune system and reducing inflammation in brain tissue damaged by radiation therapy, helping to alleviate symptoms such as headaches, cognitive issues, and neurological deficits. Corticosteroids belong to the glucocorticoid class of drugs and act by binding to specific receptors in cells to decrease the production of inflammatory substances, though long-term use can lead to significant side effects.

Investigated diseases

  • Brain Metastases

    A condition where cancer cells spread from their original location to the brain through the bloodstream. These cancer cells form new tumors in the brain tissue, which can occur in one or multiple areas. The metastatic tumors grow and may cause pressure within the skull, leading to various neurological symptoms.

  • Brain Radionecrosis

    A delayed complication that can occur after radiation therapy to the brain. It involves the death of brain tissue in areas that were previously treated with radiation. The condition develops gradually, typically months to years after radiation treatment, causing the breakdown of normal brain tissue structure. The affected brain tissue becomes damaged and may form areas of dead tissue surrounded by swelling.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510893-25-00Protocol codeBRADI ICO-2023-15Estimated enrolment84 patientsSponsorInstitut De Cancerologie De L Ouest

sourced from the EU Clinical Trials Register and site verification

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