About this trial
This study evaluates whether the addition of FET-PET-guided stereotactic radiosurgery (SRS) to Tumor Treating Fields (TTFields) improves survival outcomes in patients with recurrent IDH-wildtype glioblastoma.
Patients with recurrent glioblastoma have limited treatment options and poor prognosis. TTFields is a non-invasive antimitotic therapy that has demonstrated efficacy in recurrent glioblastoma. Stereotactic radiosurgery is commonly used in selected patients with recurrent disease; however, treatment efficacy may be limited by the infiltrative nature of glioblastoma and challenges in accurate target delineation.
The study hypothesizes that combining TTFields with FET-PET-guided stereotactic radiosurgery will improve one-year overall survival compared with TTFields alone. Participants will be randomized in a 1:1 ratio to receive either TTFields plus stereotactic radiosurgery or TTFields alone.
Eligibility criteria
Qualifiers
Age ≥18 years
Karnofsky Performance Status ≥70
Histologically confirmed IDH-wildtype glioblastoma
First, second, or third recurrence
Disqualifiers
Previous bevacizumab treatment
Planned chemotherapy or targeted therapy after study intervention
Previous stereotactic re-irradiation within the planned treatment field
More than three recurrences
Trial design
Treatments tested in this trial
- Tumor Treating Fields (TTFields)
- FET-PET-Guided Stereotactic Radiosurgery
Treatment groups
Sponsors and collaborators
Prof. Franciszek Lukaszczyk Memorial Oncology Center
Lead sponsor
Medical Research Agency, Poland
Collaborator