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

Sponsor
Prof. Franciszek Lukaszczyk Memorial Oncology Center
Study ID
NCT07668869
Status
Recruiting
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Conditions

  • Glioblastoma
  • Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype
  • Glioblastoma Multiforme, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Jun 25, 2026
Start date
Dec 30, 2025
Status verified
Jun 2026
Primary completion
Jun 30, 2030
Completion
Jun 30, 2032

Study Design

Enrollment
92 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TTFields Plus FET-PET-Guided Stereotactic Radiosurgery
    Participants receive Tumor Treating Fields (TTFields) therapy combined with FET-PET-guided stereotactic radiosurgery (SRS) for recurrent IDH-wildtype glioblastoma. TTFields treatment is administered for four months. Stereotactic radiosurgery is delivered within 14 days after initiation of TTFields according to protocol-defined target volumes based on MRI and FET-PET imaging.
  • Active Comparator: TTFields Alone
    Participants receive Tumor Treating Fields (TTFields) therapy alone for recurrent IDH-wildtype glioblastoma according to standard clinical practice. TTFields treatment is administered for four months.

Primary Outcome Measure

One-Year Overall Survival Rate [ Time Frame: 12 months after randomization ]

Central Contacts

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