Phase 3 Brain Cancer Trial, Recruiting

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

Who might be able to join this trial:

• Adults aged 18 or older
• People who have had their first episode of serious radiation-related brain injury (called symptomatic cerebral radiation necrosis, or sCRN) at least 3 months after completing a focused course of radiation treatment to the brain, where a specialist brain tumour team has confirmed the diagnosis and ruled out tumour growth as the cause
• People whose brain injury from radiation has caused a meaningful decline in neurological function (such as movement, speech, or vision), OR people experiencing headaches caused by this radiation injury that are rated at least 5 out of 10 in severity, lasting 10 or more days in a row, and not adequately relieved by paracetamol or anti-inflammatory painkillers
• People whose performance level (measured by a standard medical scale called the KPS) is scored at 90 or below
• People who have been taking no more than 1 mg per day of the steroid dexamethasone on average over the 8 weeks before joining the trial (with some flexibility in the 3 weeks immediately before joining, if higher doses were used specifically to treat the radiation injury)
• People who are able to understand the study information and complete online tests and questionnaires
• People who provide written consent to participate
• People with brain metastases (cancer that has spread to the brain) from any solid tumour type are eligible for the brain metastases group
• People with a confirmed diagnosis of a high-grade brain tumour (high-grade diffuse glioma) according to 2021 World Health Organization criteria — including specific subtypes such as grade 3–4 astrocytoma, grade 3 oligodendroglioma, or grade 4 glioblastoma — are eligible for the high-grade glioma group

Who may not be able to join:

• People who received the drug bevacizumab within 6 months before being diagnosed with the radiation brain injury
• People with a life expectancy of less than 3 months
• People showing urgent signs on scans or clinically that the brain is under dangerous pressure requiring immediate surgery
• People with a known intolerance to proteins derived from mice
• People with a known allergy or sensitivity to bevacizumab, dexamethasone, or any of their ingredients
• People with serious kidney problems, including a creatinine clearance below 30 mL/min or significant protein in the urine (confirm with trial site for specific thresholds)
• People with poorly controlled high blood pressure that remains above set limits despite taking 3 or more blood pressure medications, or a history of hypertensive crisis, hypertensive brain injury, or a related condition called RPLS
• People who have had a non-tumour-related blood vessel event — such as a stroke, heart attack, blood clot in the leg or lung, unstable chest pain, or limb artery disease — within the past 6 months
• People with a history of an aortic aneurysm or aortic tear
• People with moderate to severe heart failure (classified as NYHA grade II–IV)
• People with a history of a fistula, perforation, or abscess in the digestive system within the past 6 months
• People with a recent significant lung bleed or coughing up blood within the past month, or a lung tumour considered high-risk for bleeding by the treating doctor
• People with active gastrointestinal bleeding within the past 6 months
• People with evidence of recent bleeding in the brain on MRI within the past 3 months (small, symptom-free deposits of old blood in the tumour do not automatically exclude someone — confirm with trial site)
• People with an inherited bleeding disorder or significant clotting problem that increases bleeding risk
• People with a platelet count below 75 × 10⁹/L (a measure of blood clotting cells being too low)
• People with a significant wound, ulcer, or bone fracture that has not healed
• People who have had a major surgical procedure or serious injury within 28 days before planned study treatment, or who have a major surgery planned within 28 days after joining
• People who have had a minor surgical procedure or needle biopsy within 7 days before planned study treatment
• People who have received high-dose radiation to the chest, abdomen, or lower pelvis (the trial site would need to consult a specialist before considering these patients)
• People who are pregnant or breastfeeding; women of childbearing potential must have a negative pregnancy test within 7 days before joining, and adequate contraception is required as specified by the study
• People with other medical or psychiatric conditions that the treating doctor believes could interfere with treatment or place the person at high risk of complications
• People currently taking part in another clinical drug trial, or who have received an experimental treatment within the 30 days before starting this study

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