This study is testing a new way of treating brain tumours using tiny radioactive beads called SIR-Spheres® (90Y-labelled Resin Microspheres). These microspheres are placed into the blood vessels that feed the tumour. The treatment gives off radiation inside the tumour to try to stop it from growing. This type of treatment is called Selective Internal Radiation Therapy (SIRT), Transarterial Radioembolisation (TARE), or radioembolisation. It is already an accepted treatment for patients with liver cancer. In this study, we are testing if this treatment can be done safely in the brain and how well it works.
This study is testing a new approach to treat people with the most aggressive type of adult brain tumour, glioblastoma. It will determine whether a treatment called selective internal radiation therapy (SIRT) (also know as Transarterial Radioembolisation (TARE), or radioembolisation) is safe and effective in patients with recurrent or progressive glioblastoma. Small radioactive beads (SIR-Spheres®) are administered directly into the blood vessels that feed the tumour. This aims to selectively damage cancer cells and spare healthy tissue. PRECISE will investigate whether SIRT may reduce the volume of the tumour or slow its growth. Participants will undergo a detailed assessment to confirm they are suitable for the treatment. Those enrolled will have a planning procedure to map the blood vessels supplying the tumour, followed by SIRT treatment. Participants will also have scans and medical follow-ups after the procedure to monitor how they are going and whether the treatment is working. Safety of participants will be closely monitored by a team of specialist doctors. This study may represent the initial step towards a new treatment option for people with gliomas, who currently have very few alternatives once standard treatments have failed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Single administration of SIR-Spheres® on Day 1 with optional one-time retreatment if clinically indicated
Austin Hospital
Melbourne, Victoria, Australia
Safety - Treatment-related adverse events
Rate of any treatment-related adverse events within the first 30 days after TARE, according to CTCAE, version 6.0.
Time frame: From SIR-sphere administration (Day 1) to 30 days post SIR-sphere administration.
Safety - Severe treatment-related adverse events
Rate of any severe treatment-related adverse events (grade ≥3-5) within the first 30 days after TARE, according to CTCAE version 6.0
Time frame: From SIR-sphere administration (Day 1) to 30 days post SIR-sphere administration.
30-day mortality
Rate of all-cause mortality within 30 days following TARE.
Time frame: From SIR-sphere administration (Day 1) to 30 days post SIR-sphere administration.
Technical success of TARE
Technical success rate, defined as successful selective catheterisation and administration of SIR-Spheres® to the target volume without significant non-target deposition.
Time frame: 6 months after the last patient has been enrolled
Confirmation of dose delivery
Confirmation of dose delivery to the target volume as assessed by post-treatment PET/CT.
Time frame: 6 months after the last patient has been enrolled.
Objective response rate (ORR)
Objective response rate (ORR) according to RANO 2.0 and PET RANO 1.0 criteria.
Time frame: 6 months after the last patient has been enrolled
Disease control rate (DCR)
Disease control rate (DCR) according to RANO 2.0 and PET RANO 1.0 criteria.
Time frame: 6 months after the last patient has been enrolled
Clinical and radiographic progression-free survival (PFS)
Clinical and radiographic progression-free survival (PFS) according to NANO, RANO 2.0 and PET RANO 1.0 criteria.
Time frame: 6 months after the last patient has been enrolled
Overall survival (OS)
Overall survival (OS)
Time frame: Up to 6 months after the last patient has been enrolled.
Change from baseline in health-related quality of life measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30).
The EORTC QLQ-C30 consists of multi-item functional and symptom scales transformed to scores ranging from 0 to 100. Higher scores indicate better functioning/global health status on the functional and global health scales, whereas higher scores indicate worse symptom burden on the symptom scales.
Time frame: Assessed up to 6 months after enrolment
Change from baseline in brain cancer-specific quality of life measured using the European Organisation for Research and Treatment of Cancer Brain Neoplasm Module (EORTC QLQ-BN20).
The EORTC QLQ-BN20 comprises symptom scales transformed to scores ranging from 0 to 100, with higher scores indicating greater symptom burden (worse quality of life).
Time frame: Assessed up to 6 months after enrolment
Safety following repeat administration of SIR-Spheres® administration
Rate and severity of treatment-related adverse events in participants who proceed to a second SIR-Spheres® administration compared with participants receiving a single administration.
Time frame: Assessed up to 6 months after enrolment
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