TTFields Plus FET-PET-Guided Stereotactic Radiosurgery Versus TTFields Alone for Recurrent Glioblastoma (Tarrget 2.0)
2026年6月19日 更新者：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.
調査の概要
状態
募集
詳細な説明
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.
研究の種類
介入
入学 (推定)
92
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Agnieszka Rydzewska, Study Coordinator
- 電話番号：+48 52 3743082
- メール：glejak@co.bydgoszcz.pl
研究場所
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Bydgoszcz、ポーランド、85-796
- 募集
- Department of Neurooncology and Radiosurgery, Franciszek Lukaszczyk Oncology Center
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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One-Year Overall Survival Rate
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Overall Survival (OS)
時間枠：From randomization until death from any cause, up to 81 months
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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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：Up to 12 months after randomization
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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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2025年12月30日
一次修了 (推定)
2030年6月1日
研究の完了 (推定)
2032年6月1日
試験登録日
最初に提出
2026年6月10日
QC基準を満たした最初の提出物
2026年6月19日
最初の投稿 (実際)
2026年6月25日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月25日
QC基準を満たした最後の更新が送信されました
2026年6月19日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- Tarrget 2.0
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
IPD プランの説明
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
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
はい
米国で製造され、米国から輸出された製品。
はい
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