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.

Interventions

• Tumor Treating Fields (TTFields) · DEVICE

  Tumor Treating Fields (TTFields) therapy delivered using alternating electric fields through transducer arrays placed on the scalp. Treatment is administered continuously according to the study protocol for patients with recurrent IDH-wildtype glioblastoma.

• FET-PET-Guided Stereotactic Radiosurgery · RADIATION

  Stereotactic radiosurgery planned using MRI and FET-PET imaging for treatment of recurrent IDH-wildtype glioblastoma. Radiosurgery is delivered within 14 days after initiation of TTFields according to protocol-defined target volumes.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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

Sites (1)

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