Study on Bevacizumab and Dexamethasone for Treating Brain Radiation Damage in Patients with High-Grade Glioma or Brain Metastases

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What is this study about?

This clinical trial is focused on studying the treatment of cerebral radiation necrosis, a condition that can occur after radiation therapy for brain tumors. The study involves patients who have received radiation for either high-grade glioma or brain metastases. The trial will compare two treatments: bevacizumab, a medication given through an IV infusion, and dexamethasone, a type of corticosteroid taken orally. The purpose of the study is to determine which treatment is more effective as a first-line option for managing symptoms of cerebral radiation necrosis.

Participants in the study will receive either bevacizumab or dexamethasone over a period of 12 weeks. The study will monitor the participants’ response to the treatment, including any changes in their symptoms and overall health. The trial will also assess the cost-effectiveness of each treatment option. Throughout the study, participants will undergo regular assessments to track their progress and any side effects they may experience.

The trial aims to provide valuable information on the best treatment approach for patients with cerebral radiation necrosis following radiation therapy for high-grade glioma or brain metastases. By comparing bevacizumab and dexamethasone, the study seeks to improve the quality of life and health outcomes for individuals affected by this condition.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, medical history, and current health status.

Written informed consent is required to participate in the study.

2 randomization

Participants are randomly assigned to one of two treatment groups: one receiving bevacizumab and the other receiving dexamethasone.

3 treatment administration

For those in the bevacizumab group, the medication is administered through an intravenous (IV) infusion.

Participants in the dexamethasone group take the medication orally.

4 treatment duration

The treatment continues for a specified period, with regular monitoring to assess the response and any side effects.

5 evaluation of primary endpoints

After 12 weeks, the primary endpoints are evaluated. These include a favorable clinical response, which is defined by reduced use of dexamethasone and improvements in performance and neurological assessments.

6 evaluation of secondary endpoints

Secondary endpoints are assessed, including physical functioning, reduction of cerebral edema, cognitive functioning, seizure frequency, and treatment-related adverse events.

Long-term outcomes such as recurrence-free survival and overall survival are also monitored.

7 end of treatment

The treatment phase concludes, and participants are monitored for any late-onset side effects or recurrence of symptoms.

Who Can Join the Study?

Must be 18 years old or older.
First episode of sCRN (a condition related to brain treatment) must occur at least 3 months after finishing focused brain radiation, as confirmed by a local expert team. There should be a clear diagnosis of this condition without signs of tumor growth.
KPS score (a measure of daily living abilities) should be 90 or less, with at least a two-point drop in one area of the NANO scale (a tool to assess neurological function) due to sCRN.
Daily use of dexamethasone (a medication) should be 1 mg or less for the 8 weeks before joining the study. Higher doses are allowed in the week before joining if used specifically for treating sCRN.
Must be able to understand the study information, and complete online tests and questionnaires.
Must provide written informed consent to participate.
For patients with brain metastases (BM): Must have BM from a solid tumor, which includes all types of primary tumors.
For patients with high-grade glioma (HGG): Must have a confirmed diagnosis of high-grade diffuse glioma according to the WHO 2021 criteria, which includes specific types like astrocytoma and glioblastoma.

Who Cannot Join the Study?

Patients with other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who are unable to follow the study procedures.
Patients with allergies to the study medications.
Patients with certain heart conditions.
Patients with uncontrolled high blood pressure.
Patients with severe liver or kidney disease.
Patients with a history of bleeding disorders.
Patients who are taking medications that could interfere with the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
University Hospital Maastricht	Maastricht	The Netherlands

Other Sites

Site Name	City	Country
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Medical Center Haaglanden	Leidschendam	The Netherlands
Netherlands Cancer Institute	Amsterdam	The Netherlands
Lobeg Umddstsvhrrv Mdwsjkq Cowcrbi (mhoxo	Leiden	The Netherlands
Amgfauyzq Uzv	Amsterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.01.2025

Trial locations

Investigated drugs:

Bevacizumab is a medication used in this trial to treat patients with cerebral radiation necrosis, a condition that can occur after radiation therapy for brain tumors. It works by blocking a protein that helps tumors grow new blood vessels, which can reduce swelling and improve symptoms.

Dexamethasone is a type of corticosteroid used in this trial as a comparison treatment. It helps reduce inflammation and swelling in the brain, which can alleviate symptoms associated with cerebral radiation necrosis.

Investigated diseases:

Glioma

Brain Metastases – This condition occurs when cancer cells spread from their original site to the brain. It can lead to various neurological symptoms depending on the location and size of the metastases. Patients may experience headaches, seizures, or changes in cognitive or motor functions. The progression of brain metastases can vary, with some growing rapidly while others remain stable for a period. The presence of multiple metastases is common, and they can affect different parts of the brain simultaneously.

High Grade Glioma – This is a type of aggressive brain tumor that originates from glial cells. It is characterized by rapid growth and a tendency to infiltrate surrounding brain tissue. Symptoms often include headaches, seizures, and neurological deficits such as weakness or speech difficulties. The tumor’s progression is typically fast, leading to increased pressure within the skull and worsening symptoms. High grade gliomas are known for their ability to recur even after treatment. They are often located in areas of the brain that control vital functions, complicating management.

Trial ID:

2024-512466-34-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Bevacizumab and Dexamethasone for Treating Brain Radiation Damage in Patients with High-Grade Glioma or Brain Metastases

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?