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
Previous bevacizumab treatment
Planned chemotherapy or targeted therapy after study intervention
Previous stereotactic re-irradiation within the planned treatment field
More than three recurrences
Parallel
Tumor Treating Fields (TTFields)
DeviceTumor 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
RadiationStereotactic 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.
One-Year Overall Survival Rate
Proportion of participants alive 12 months after randomization
Overall Survival (OS)
Overall survival is defined as the time from randomization to death from any cause. Participants who are alive at the time of analysis will be censored at the date of last contact. Median overall survival will be estimated using the Kaplan-Meier method.
Progression-Free Survival (PFS)
Progression-free survival is defined as the time from randomization to radiographic disease progression according to RANO 2.0 criteria or death from any cause, whichever occurs first. Participants without an event will be censored at the date of last disease assessment. Median, 6-month, and 12-month progression-free survival rates will be estimated.
Objective Response Rate (ORR)
Objective response rate is defined as the proportion of participants achieving a complete response (CR) or partial response (PR) according to RANO 2.0 criteria within 12 months after randomization. Best overall response will be determined using serial MRI assessments.
Radiation-Induced Contrast Enhancement (RICE)
Radiation-induced contrast enhancement is defined as new or increasing contrast enhancement observed on follow-up MRI that subsequently remains stable or resolves without evidence of tumor progression. The incidence of radiation-induced contrast enhancement (RICE) will be assessed and compared between study groups.
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Prof. Franciszek Lukaszczyk Memorial Oncology Center
Lead sponsor
Medical Research Agency, Poland
Collaborator
