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 glioblastoma (a type of brain tumour), confirmed by tissue testing, with a specific genetic result showing no IDH mutation
• People who have already received first-line treatment that included brain surgery or a biopsy, plus a course of radiotherapy at a standard or shortened dose
• People who also received at least one course of chemotherapy and/or immune or biological therapy as part of their first-line treatment (with or without Tumour-Treating Fields)
• People whose tumour has clearly grown back for the first time, with a measurable tumour on MRI scan taken within 14 days of joining, and at least 12 weeks having passed since completing radiotherapy (with some exceptions — confirm with trial site)
• People whose treating team considers them suitable for brain surgery with removal of at least half of the visible tumour
• People whose largest tumour measurement is 5 cm or less before joining the trial
• People who are functioning reasonably well in daily life, as measured by a standard performance scale (WHO performance status 2 or below)
• People aged 18 years or older
• People who have recovered from serious side effects of previous cancer treatments, and where enough time has passed since the last treatment before the planned surgery date (the required gap varies depending on the type of treatment — confirm with trial site)
• People whose blood counts, liver function, and kidney function are within acceptable ranges, confirmed by a blood test taken within 14 days of joining
• People who are able to understand the trial information and are willing to sign a consent form
• People who could become pregnant must have a negative pregnancy test within 14 days of joining, and must agree to use an acceptable form of contraception during treatment and for at least one month after the last dose of a chemotherapy drug called carboplatin (if assigned to the experimental treatment group)
• Male participants must agree to use condoms during treatment and for at least three months after the last carboplatin dose (if in the experimental group), and must not donate sperm during this time
• People who are covered by a health plan or social security scheme that covers routine care costs (requirements may vary by country — confirm with trial site)

Who may not be able to join:

• People whose tumour appears in multiple separate areas of the brain, unless all areas fall within a 5 cm zone
• People whose tumour is located in the back part of the brain (posterior fossa)
• People with a known BRAF or NTRK gene mutation in their tumour
• People considered at higher risk of surgical wound infection, for example those who have had two or more brain surgeries in the past three months, have poor skin condition, or a previously infected surgical site
• People who have been taking high or stable doses of steroid medication (such as dexamethasone at 6 mg per day or more) in the seven days before joining, unless prescribed for a reason other than brain swelling caused by the tumour
• People who have a known reason they cannot take the chemotherapy drugs carboplatin, CCNU, or temozolomide (TMZ)
• People with a known allergic reaction to the components of the ultrasound contrast agent used in this trial
• People who previously received a medication called bevacizumab for tumour progression (rather than for managing brain swelling)
• People with nerve damage or neuropathy rated as moderate or severe
• People with epilepsy that is not well controlled, or evidence of raised pressure in the brain
• People with a known brain aneurysm, or who have had a significant bleed inside the tumour
• People who have certain permanent metal implants in the brain or blood vessels that cannot be removed (such as coils, clips, shunts, stents, or wafers)
• People who need to stay on blood thinning or anti-clotting medication that cannot be temporarily paused (those who can safely pause these medications may still be considered — confirm with trial site)
• People currently taking certain anti-seizure medications that affect how other drugs are processed by the body (specifically phenytoin, carbamazepine and similar drugs, and phenobarbital), unless already switched to a different anti-seizure medication
• People who have had another cancer within the past three years, with some exceptions such as certain treated skin cancers or cervical carcinoma in situ
• People with a known active or ongoing infection
• People with serious heart conditions, a known right-to-left heart shunt, severely high lung blood pressure, uncontrolled high blood pressure, or acute breathing difficulties
• People with a known allergy to gadolinium or other contrast agents used in MRI or other imaging
• People who have problems regulating body temperature or sensing temperature
• People who are pregnant or breastfeeding
• People with other serious medical or psychological conditions that, in the opinion of the study doctor, could interfere with safely receiving the trial treatment or affect the accuracy of trial results
• People under legal guardianship, legal protection orders, or who are deprived of their liberty by a court or administrative decision
• People who develop a significant medical illness or impairment after joining that the study doctor believes would prevent safe participation in the trial

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