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NCT Number: NCT07668869

TTFields Plus FET-PET-Guided Stereotactic Radiosurgery Versus TTFields Alone for 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.

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Key information

Conditions

Glioblastoma Astrocytoma Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype Glioblastoma Multiforme, Adult Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Snyder Robinson syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurooncology and Radiosurgery, Franciszek Lukaszczyk Oncology Center

Bydgoszcz, 85-796, Poland

Location status: Recruiting

About this study

Glioblastoma is the most common malignant primary brain tumor in adults and remains associated with poor prognosis despite multimodal treatment. There is currently no established standard therapy for recurrent glioblastoma, and outcomes remain unsatisfactory.

Tumor Treating Fields (TTFields) are low-intensity, intermediate-frequency alternating electric fields that disrupt mitosis and inhibit tumor growth. TTFields have demonstrated efficacy in recurrent and newly diagnosed glioblastoma with minimal systemic toxicity.

Stereotactic radiosurgery (SRS) is an established local treatment option for selected patients with recurrent glioblastoma. However, MRI-based target delineation may underestimate the true extent of infiltrative tumor growth. FET-PET imaging provides improved visualization of metabolically active tumor tissue and may improve treatment precision.

Preclinical studies suggest synergistic effects between TTFields and radiation therapy through increased radiosensitivity and modulation of DNA repair mechanisms. Additional immunomodulatory effects may further enhance treatment efficacy.

This prospective randomized single-center study will compare TTFields combined with FET-PET-guided stereotactic radiosurgery versus TTFields alone in patients with recurrent IDH-wildtype glioblastoma. The primary objective is to determine whether combined treatment improves the one-year overall survival rate.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Previous bevacizumab treatment
  • Planned chemotherapy or targeted therapy after study intervention
  • Previous stereotactic re-irradiation within the planned treatment field
  • More than three recurrences
  • Significant psychiatric disorders
  • Significant unrelated neurological disease
  • Implanted pacemaker, defibrillator, deep brain stimulator, or other incompatible electronic device
  • Pregnancy or breastfeeding
  • Active intracranial hemorrhage
  • Uncontrolled hypertension
  • Severe renal dysfunction
  • Participation in another interventional study likely to interfere with this study

Treatment and study plan

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.

Primary outcomes

  1. One-Year Overall Survival Rate

    Time frame: 12 months after randomization

    Proportion of participants alive 12 months after randomization

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: From randomization until death from any cause, up to 81 months

    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.

  2. Progression-Free Survival (PFS)

    Time frame: Up to 12 months after randomization

    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.

  3. Objective Response Rate (ORR)

    Time frame: Up to 12 months after randomization

    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.

  4. Radiation-Induced Contrast Enhancement (RICE)

    Time frame: Up to 12 months after randomization

    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.

  5. Treatment-Related Adverse Events

    Time frame: From randomization through 12 months after randomization

    Treatment-related adverse events will be assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0. The proportion of participants experiencing grade 3 or higher treatment-related adverse events will be compared between treatment groups.

  6. Patterns of Failure

    Time frame: Up to 12 months after randomization

    Patterns of failure will be evaluated based on the location of disease progression relative to the baseline recurrent tumor volume identified on screening MRI and treatment planning imaging. Disease progression will be classified as local, marginal, or distant.

  7. Molecular Predictors of overall survival

    Time frame: Up to 81 months after randomization

    Associations between molecular tumor characteristics, including MGMT promoter methylation status and other available molecular markers, and treatment outcomes will be evaluated to identify potential predictors of overall survival

  8. Corticosteroid Requirements

    Time frame: From randomization until disease progression, up to 12 months after randomization

    Corticosteroid requirements will be assessed as the cumulative and daily corticosteroid dose administered from randomization until disease progression. Changes in corticosteroid use over time will be compared between treatment groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Agnieszka Rydzewska, Study Coordinator

CONTACT

[email protected]

+48 52 3743082

Sponsors and collaborators

Lead sponsor

Prof. Franciszek Lukaszczyk Memorial Oncology Center

Other

Collaborators

  • Medical Research Agency, Poland

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2030
Study completion
2032
First posted
Jun 25, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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