Phase 3 Brain Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with radionecrosis (damage to brain tissue caused by radiation therapy), supported by specific MRI scan findings and nuclear medicine imaging results
• People whose symptoms have not improved or have gotten worse despite taking corticosteroid medication (such as prednisolone) at a dose of at least 1 mg/kg/day for at least 2 weeks, or whose symptoms returned when the dose was reduced
• People who received radiation treatment to the brain (using photons or proton therapy) for brain metastases at least 3 months before joining the trial, in one or more rounds of treatment
• People aged 18 years or older
• People with a general health and functioning score (ECOG) of 3 or lower, meaning they are able to carry out at least some self-care
• People with a life expectancy of at least 3 months, based on a specific brain metastases scoring system (DS-GPA score of 0.5 or higher)
• People who have never previously received the drug Bevacizumab specifically to treat radionecrosis
• People whose blood test results show the bone marrow, kidneys, liver, and blood clotting system are all functioning within acceptable ranges (confirm with trial site for specific numbers)
• Women who could become pregnant must agree to use effective contraception during treatment and for 6 months after treatment ends
• People who have signed an informed consent form agreeing to take part
• People who are enrolled in a social security scheme (this appears to be a requirement specific to the country where the trial is taking place — confirm with trial site)

Who may not be able to join:

• People who have signs of active bleeding, or a medical condition that significantly raises the risk of bleeding, such as bleeding in the brain, a blood clotting disorder, coughing up blood, or a recent history of bowel obstruction, abdominal fistula, bowel perforation, or abdominal abscess within the past 28 days
• People who have had a severe blood clot in a vein (grade 4) or a blood clot in an artery of the limbs
• People showing signs of very high pressure inside the skull that may require emergency surgery
• People who have had major surgery or a serious injury within the past 28 days, or minor surgery within the past 3 days
• People with serious heart or blood vessel conditions in the past 6 months, such as poorly controlled high blood pressure, stroke, heart attack, irregular heart rhythm, unstable chest pain, or heart failure
• People with a history of hypertensive crisis (a sudden, severe spike in blood pressure) or hypertensive encephalopathy (brain problems caused by very high blood pressure)
• People who are scheduled to receive radiation therapy to the head, neck, chest, or abdomen during the study
• People who have received Bevacizumab within 3 months before being enrolled in the trial
• People whose brain metastases are currently growing or spreading (progressive brain metastases)
• People who have had a severe allergic reaction to Bevacizumab in the past
• People with a known allergy or sensitivity to Bevacizumab or any of its ingredients
• People for whom Bevacizumab is medically contraindicated according to the European prescribing guidelines
• People who are pregnant or breastfeeding
• People whose mental health or personal circumstances may make it difficult to give informed consent or to follow the study requirements
• People who are under legal guardianship or have had their freedom restricted by a legal or administrative order
• People in whom a new brain metastasis is found during the imaging tests done at the start of the trial
• People who have previously developed a condition called Posterior Reversible Encephalopathy Syndrome (PRES) while taking Bevacizumab
• People with a known allergy to products derived from Chinese Hamster Ovary cells, or to other similar laboratory-made antibody treatments

Important: Always verify eligibility with the trial site directly before applying.