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

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What is this study about?

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.

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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Oncopole Claudius Regaud	Toulouse	France
Centr Georges Francois Leclerc	Dijon	France
Centre de Radiothérapie Guillaume le Conquérant	Le Havre	France
Centre Hospitalier Intercommunal Creteil	Creteil	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France

Other Sites

Site Name	City	Country
Centre Hospitalier Prive Saint-Gregoire	Saint-Gregoire	France
Hopital D’Instruction Des Armees Percy	Clamart	France
Hospices Civils De Lyon	Lyon	France
Centre Hospitalier Bretagne Atlantique	Vannes	France
Polyclinique Bordeaux Nord Aquitaine	Bordeaux	France
Societe De Recherche Oncologique Clinique 37	Chambray Les Tours	France
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Centre Regional Lutte Contre Le Cancer	STRASBOURG, Alsace	France
Centre Francois Baclesse	Caen	France
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France
Groupe Hospitalier Rance Emeraude	Saint-Malo	France
Cqnvfi Lbfz Bzxegp	Lyon	France
Iubfksmo Pyxqspskfhfikxy Csrqmm Csvjiy	Marseille	France
Ivkwlfnd Cawom	Paris	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	29.04.2025

Trial locations

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.

Investigated diseases:

Metastases to central nervous system

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 ID:

2024-510893-25-00

Protocol code:

BRADI ICO-2023-15

NCT ID:

NCT06471465

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?