GlioblastomaNCT07668869
TTFields Plus FET-PET-Guided Stereotactic Radiosurgery Versus TTFields Alone for Recurrent Glioblastoma (Tarrget 2.0)
A study testing Tumor Treating Fields (TTFields) and FET-PET-Guided Stereotactic Radiosurgery in people with Glioblastoma and Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype, run by Prof. Franciszek Lukaszczyk Memorial Oncology Center at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype, Glioblastoma Multiforme, Adult
- What is being tested?
- Tumor Treating Fields (TTFields) and FET-PET-Guided Stereotactic Radiosurgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 sitePoland
- Study dates
- 30 Dec 2025to Jun 2032
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Department of Neurooncology and Radiosurgery, Franciszek Lukaszczyk Oncology Center
Bydgoszcz, 85-796
About this study
Official 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)
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.
Read the detailed description
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.
- Conditions
- Glioblastoma, Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype, Glioblastoma Multiforme, Adult
- Being tested
- Tumor Treating Fields (TTFields), FET-PET-Guided Stereotactic Radiosurgery
- Keywords
- glioblastoma, TTF, SRS, radiosurgery, stereotactic radiotherapy
- Medical subject headings
- Glioblastoma, Snyder Robinson syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 RadiosurgeryRadiation
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Tumor Treating Fields (TTFields) |
What is being measured
The primary outcome is the main question the study is designed to answer.
One-Year Overall Survival Rate
Proportion of participants alive 12 months after randomization
Measured: 12 months after randomization
Secondary outcomes (8)
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.
Measured: From randomization until death from any cause, up to 81 months
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.
Measured: Up to 12 months after randomization
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.
Measured: Up to 12 months after randomization
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.
Measured: Up to 12 months after randomization
Treatment-Related Adverse Events
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.
Measured: From randomization through 12 months after randomization
Patterns of Failure
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.
Measured: Up to 12 months after randomization
Molecular Predictors of overall survival
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
Measured: Up to 81 months after randomization
Corticosteroid Requirements
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.
Measured: From randomization until disease progression, up to 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start30 Dec 2025
- Primary completionJun 2030 (estimated)
- Study completionJun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Franciszek Lukaszczyk Memorial Oncology Center
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Agency, Poland
- Responsible party
- Principal investigator, Maciej Harat, Prof. Franciszek Lukaszczyk Memorial Oncology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668869
- Sponsor's protocol ID
- Tarrget 2.0
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Individual participant data that underlie the results reported in publications may be made available upon reasonable request to the Principal Investigator, following approval of a research proposal and execution of a data sharing agreement
Publications
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.
PubMed 27428784Cuneo 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.
PubMed 21489708Harat 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.
PubMed 37516762Harat 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.
PubMed 35552391Albert 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.
PubMed 27106405Stupp 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.
PubMed 29260225Stupp 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.
PubMed 22608262