TTFields Plus FET-PET-Guided Stereotactic Radiosurgery Versus TTFields Alone for Recurrent Glioblastoma (Tarrget 2.0)

Summary

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

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

Conditions4

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