TTFields with FET-PET–Guided SRS for Recurrent Glioblastoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, single-center study compares two treatment approaches for recurrent IDH-wildtype glioblastoma: TTFields alone versus TTFields combined with FET-PET-guided stereotactic radiosurgery. Participants are adults with up to three recurrences and measurable MRI lesions, who have already received radiotherapy and temozolomide. The primary goal is to determine if the combined therapy improves one-year overall survival. The trial leverages FET-PET imaging to guide precise targeting of SRS and may provide insight into potential synergistic effects with TTFields. Safety and feasibility data will also be collected.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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's running

• Department of Neurooncology and Radiosurgery, Franciszek Lukaszczyk Oncology Center
  Bydgoszcz, Poland Recruiting

Study contacts

• Study coordinator: Agnieszka Rydzewska, Study Coordinator
• Email: glejak@co.bydgoszcz.pl
• Phone: +48 52 3743082

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.