A Feasibility Study to Evaluate the Safety of the TheraSphere Glioblastoma (GBM) Device in Patients With Recurrent GBM
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston Scientific Corporation
About this trial
The FRONTIER Study is a prospective, interventional, single-arm, multi-center, study to assess the safety and technical feasibility of TheraSphere GBM in patients with recurrent GBM.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject is 18 years or older and has signed and dated the trial informed consent form (ICF)
Life expectancy ≥ 12 weeks
Subject is willing and able to comply with the trial testing, procedures, and follow-up schedule
History of a histologically confirmed diagnosis of glioblastoma per 2021 WHO criteria
Disqualifiers
Have bilateral gadolinium enhancing disease, tumor located in the posterior fossa, tumor involving critical subcortical structures (thalamus/hypothalamus, midbrain, brainstem, corticospinal tract, internal capsule, cerebral peduncle), tumor approximating or invading the brainstem and/or optic chiasma, leptomeningeal disease, or extracranial metastatic disease
Have received more than 1 course of prior cranial radiotherapy (EBRT)
Have received radiosurgery, brachytherapy, or hypofractionated radiotherapy
Have received more than 2 systemic treatment protocols (lines of treatment), not including maintenance temozolomide
Trial design
Design model
Parallel
Treatments tested in this trial
TheraSphere GBM
DeviceSingle treatment of TheraSphere GBM device
Treatment groups
36 Participants
are divided into 4 treatment groupsGroup A: Treatment Group AExperimental treatment 1 intervention
Group B: Treatment Group BExperimental treatment 1 intervention
Group C: Treatment Group CExperimental treatment 1 intervention
Group D: Treatment Group DExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The number of grade 3-5 non-hematological toxicities
Time frame
30 days post index procedure2
The number of ≥ grade 3 CNS toxicities related to non-target embolization
Time frame
30 days post index procedure3
Occurrence of symptomatic brain radiation necrosis requiring medical or surgical intervention and confirmed by pathology
Time frame
30 days post index procedure4
The number of Grade 4 neutropenia events persisting for longer than 5 days
Time frame
30 days post index procedureSecondary outcomes
1
Rate of any treatment-related adverse events and treatment-related serious adverse events (not including predefined Limiting Toxicities) from first patient enrolled through study completion.
Time frame
Enrollment through 6 months post index procedure2
Change in post-treatment neurological function as assessed by the National Institute of Health Stroke Scale (NIHSS).
The NIHSS is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment.
Time frame
Enrollment through 6 months post index procedure3
Change in post-treatment neurological function as assessed by the modified Rankin Scale (mRS).
The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability on a scale from 0 (no symptoms at all) to 6 (death).
Time frame
Enrollment through 6 months post index procedure4
Technical Success/Feasibility of TheraSphere GBM - ability to deliver the projected radiation absorbed dose (+/- 20%) to the perfused volume for all patients treated with the device. Assessed from pre-screening through post-device delivery PET-CT/MRI.
Time frame
Pre-screening through post-device delivery PET-CT/MRI.Sponsors and contacts
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Source ClinicalTrials.gov