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

NCT07668869 | Recruiting DMC FDA Device

• 1 other identifier: Tarrget 2.0
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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 Multiforme, Adult; Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype

Keywords

glioblastoma, TTF, SRS, radiosurgery, stereotactic radiotherapy

Outcome Measures

Primary Outcomes (1)

• One-Year Overall Survival Rate

  Proportion of participants alive 12 months after randomization

  12 months after randomization

Secondary Outcomes (8)

• Overall Survival (OS)

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

• Progression-Free Survival (PFS)

  Up to 12 months after randomization

• Objective Response Rate (ORR)

  Up to 12 months after randomization

• Radiation-Induced Contrast Enhancement (RICE)

  Up to 12 months after randomization

• Treatment-Related Adverse Events

  From randomization through 12 months after randomization

Study Arms (2)

TTFields Plus FET-PET-Guided Stereotactic Radiosurgery

EXPERIMENTAL

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.

Device: Tumor Treating Fields (TTFields); Radiation: FET-PET-Guided Stereotactic Radiosurgery

TTFields Alone

ACTIVE COMPARATOR

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.

Device: Tumor Treating Fields (TTFields)

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.

TTFields Alone; TTFields Plus FET-PET-Guided Stereotactic Radiosurgery

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.

TTFields Plus FET-PET-Guided Stereotactic Radiosurgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Franciszek Lukaszczyk Memorial Oncology Center: lead
• Medical Research Agency, Poland: collaborator

Study Sites (1)

Department of Neurooncology and Radiosurgery, Franciszek Lukaszczyk Oncology Center

Bydgoszcz, 85-796, Poland

RECRUITING

Related Publications (7)

• Imber BS, Kanungo I, Braunstein S, Barani IJ, Fogh SE, Nakamura JL, Berger MS, Chang EF, Molinaro AM, Cabrera JR, McDermott MW, Sneed PK, Aghi MK. Indications and Efficacy of Gamma Knife Stereotactic Radiosurgery for Recurrent Glioblastoma: 2 Decades of Institutional Experience. Neurosurgery. 2017 Jan 1;80(1):129-139. doi: 10.1227/NEU.0000000000001344.

  PMID: 27428784 BACKGROUND

• Cuneo KC, Vredenburgh JJ, Sampson JH, Reardon DA, Desjardins A, Peters KB, Friedman HS, Willett CG, Kirkpatrick JP. Safety and efficacy of stereotactic radiosurgery and adjuvant bevacizumab in patients with recurrent malignant gliomas. Int J Radiat Oncol Biol Phys. 2012 Apr 1;82(5):2018-24. doi: 10.1016/j.ijrobp.2010.12.074. Epub 2011 Apr 12.

  PMID: 21489708 BACKGROUND

• Harat M, Rakowska J, Harat M, Szylberg T, Furtak J, Miechowicz I, Malkowski B. Combining amino acid PET and MRI imaging increases accuracy to define malignant areas in adult glioma. Nat Commun. 2023 Jul 29;14(1):4572. doi: 10.1038/s41467-023-39731-8.

  PMID: 37516762 BACKGROUND

• Harat M, Blok M, Miechowicz I, Wiatrowska I, Makarewicz K, Malkowski B. Safety and Efficacy of Irradiation Boost Based on 18F-FET-PET in Patients with Newly Diagnosed Glioblastoma. Clin Cancer Res. 2022 Jul 15;28(14):3011-3020. doi: 10.1158/1078-0432.CCR-22-0171.

  PMID: 35552391 BACKGROUND

• Albert NL, Weller M, Suchorska B, Galldiks N, Soffietti R, Kim MM, la Fougere C, Pope W, Law I, Arbizu J, Chamberlain MC, Vogelbaum M, Ellingson BM, Tonn JC. Response Assessment in Neuro-Oncology working group and European Association for Neuro-Oncology recommendations for the clinical use of PET imaging in gliomas. Neuro Oncol. 2016 Sep;18(9):1199-208. doi: 10.1093/neuonc/now058. Epub 2016 Apr 21.

  PMID: 27106405 BACKGROUND

• Stupp R, Taillibert S, Kanner A, Read W, Steinberg D, Lhermitte B, Toms S, Idbaih A, Ahluwalia MS, Fink K, Di Meco F, Lieberman F, Zhu JJ, Stragliotto G, Tran D, Brem S, Hottinger A, Kirson ED, Lavy-Shahaf G, Weinberg U, Kim CY, Paek SH, Nicholas G, Bruna J, Hirte H, Weller M, Palti Y, Hegi ME, Ram Z. Effect of Tumor-Treating Fields Plus Maintenance Temozolomide vs Maintenance Temozolomide Alone on Survival in Patients With Glioblastoma: A Randomized Clinical Trial. JAMA. 2017 Dec 19;318(23):2306-2316. doi: 10.1001/jama.2017.18718.

  PMID: 29260225 BACKGROUND

• Stupp R, Wong ET, Kanner AA, Steinberg D, Engelhard H, Heidecke V, Kirson ED, Taillibert S, Liebermann F, Dbaly V, Ram Z, Villano JL, Rainov N, Weinberg U, Schiff D, Kunschner L, Raizer J, Honnorat J, Sloan A, Malkin M, Landolfi JC, Payer F, Mehdorn M, Weil RJ, Pannullo SC, Westphal M, Smrcka M, Chin L, Kostron H, Hofer S, Bruce J, Cosgrove R, Paleologous N, Palti Y, Gutin PH. NovoTTF-100A versus physician's choice chemotherapy in recurrent glioblastoma: a randomised phase III trial of a novel treatment modality. Eur J Cancer. 2012 Sep;48(14):2192-202. doi: 10.1016/j.ejca.2012.04.011. Epub 2012 May 18.

  PMID: 22608262 BACKGROUND

MeSH Terms

Conditions

Glioblastoma; Snyder Robinson syndrome

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

Agnieszka Rydzewska, Study Coordinator

CONTACT

+48 52 3743082; glejak@co.bydgoszcz.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 25, 2026
• Study Start: December 30, 2025
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2032
• Last Updated: June 25, 2026

Record last verified: 2026-06

Locations

PL (1)