TTFields Plus FET-PET-Guided Stereotactic Radiosurgery Versus TTFields Alone for Recurrent Glioblastoma (Tarrget 2.0)
Recruiting now · Not applicable
Conditions studied: Glioblastoma, Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype, Glioblastoma Multiforme, Adult
In brief
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.
Key facts
- Study ID
- NCT07668869
- Run by
- Prof. Franciszek Lukaszczyk Memorial Oncology Center
- People needed
- 92
- Starts
- 2025-12-30
- Expected to finish
- 2032-06-01
- Last updated by the study team
- 2026-06-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥18 years
- Karnofsky Performance Status ≥70
- Histologically confirmed IDH-wildtype glioblastoma
- First, second, or third recurrence
- Radiological recurrence according to RANO 2.0 criteria
- Prior radiotherapy and temozolomide treatment
- At least 6 months since completion of previous radiotherapy
- Contrast-enhancing recurrent lesion visible on MRI
- Maximum recurrent lesion diameter ≤5 cm
- Available molecular profile including IDH and MGMT status
- Adequate hematologic, renal, and hepatic function
- Written informed consent
You may not qualify if…
- Previous bevacizumab treatment
- Planned chemotherapy or targeted therapy after study intervention
- Previous stereotactic re-irradiation within the planned treatment field
- More than three recurrences
- Significant psychiatric disorders
- Significant unrelated neurological disease
- Implanted pacemaker, defibrillator, deep brain stimulator, or other incompatible electronic device
- Pregnancy or breastfeeding
- Active intracranial hemorrhage
- Uncontrolled hypertension
- Severe renal dysfunction
- Participation in another interventional study likely to interfere with this study
Where it is running
- Department of Neurooncology and Radiosurgery, Franciszek Lukaszczyk Oncology Center — Bydgoszcz, Poland (enrolling)
Full record on ClinicalTrials.gov
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