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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorProf. Franciszek Lukaszczyk Memorial Oncology Center

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

92 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Prof. Franciszek Lukaszczyk Memorial Oncology Center

Lead sponsor

Medical Research Agency, Poland

Collaborator