TTFields Plus FET-PET-Guided Stereotactic Radiosurgery Versus TTFields Alone for Recurrent Glioblastoma (Tarrget 2.0)
19 juin 2026 mis à jour par: Maciej Harat, Prof. Franciszek Lukaszczyk Memorial Oncology Center
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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
92
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Agnieszka Rydzewska, Study Coordinator
- Numéro de téléphone: +48 52 3743082
- E-mail: glejak@co.bydgoszcz.pl
Lieux d'étude
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Bydgoszcz, Pologne, 85-796
- Recrutement
- Department of Neurooncology and Radiosurgery, Franciszek Lukaszczyk Oncology Center
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
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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.
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.
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Comparateur actif: 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.
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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One-Year Overall Survival Rate
Délai: 12 months after randomization
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Proportion of participants alive 12 months after randomization
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12 months after randomization
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Overall Survival (OS)
Délai: 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.
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From randomization until death from any cause, up to 81 months
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Progression-Free Survival (PFS)
Délai: Up to 12 months after randomization
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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.
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Up to 12 months after randomization
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Objective Response Rate (ORR)
Délai: Up to 12 months after randomization
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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.
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Up to 12 months after randomization
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Radiation-Induced Contrast Enhancement (RICE)
Délai: Up to 12 months after randomization
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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.
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Up to 12 months after randomization
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Treatment-Related Adverse Events
Délai: From randomization through 12 months after randomization
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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.
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From randomization through 12 months after randomization
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Patterns of Failure
Délai: 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.
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Up to 12 months after randomization
|
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Molecular Predictors of overall survival
Délai: Up to 81 months after randomization
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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
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Up to 81 months after randomization
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Corticosteroid Requirements
Délai: From randomization until disease progression, up to 12 months after randomization
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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.
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From randomization until disease progression, up to 12 months after randomization
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
30 décembre 2025
Achèvement primaire (Estimé)
1 juin 2030
Achèvement de l'étude (Estimé)
1 juin 2032
Dates d'inscription aux études
Première soumission
10 juin 2026
Première soumission répondant aux critères de contrôle qualité
19 juin 2026
Première publication (Réel)
25 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
25 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
19 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Tarrget 2.0
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
Description du régime IPD
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
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Oui
produit fabriqué et exporté des États-Unis.
Oui
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .