Tumor Treating Fields (TTFields) Concomitant With Stereotactic Radiosurgery Based on FET-PET vs TTFields Alone for the Treatment of Recurrent, Glioblastoma (Tarrget 2.0)
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.
• 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