TTFields Plus FET-PET-Guided Stereotactic Radiosurgery Versus TTFields Alone for Recurrent Glioblastoma (Tarrget 2.0)
NCT07668869 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92
Last updated 2026-06-25
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.
Conditions
- Glioblastoma
- Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype
- Glioblastoma Multiforme, Adult
Interventions
- DEVICE
-
Tumor Treating Fields (TTFields)
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.
- RADIATION
-
FET-PET-Guided Stereotactic Radiosurgery
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.
Sponsors & Collaborators
-
Medical Research Agency, Poland
collaborator OTHER_GOV -
Prof. Franciszek Lukaszczyk Memorial Oncology Center
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-12-30
- Primary Completion
- 2030-06-30
- Completion
- 2032-06-30
- FDA Device
- Yes
Countries
- Poland
Study Locations
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