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Lomustine with or without reirradiation for first progression of glioblastoma, LEGATO, EORTC-2227-BTG: study protocol for a randomized phase III study

M. Preusser, T. Kazda, E. Le Rhun, F. Sahm, M. Smits, J. Gempt, JA. Koekkoek, AF. Monti, M. Csanadi, JG. Pitter, H. Bulbek, B. Fournier, C. Quoilin, T. Gorlia, M. Weller, G. Minniti, European Organisation for Research, Treatment of Cancer (EORTC)...

. 2024 ; 25 (1) : 366. [pub] 20240607

Language English Country England, Great Britain

Document type Journal Article, Clinical Trial Protocol

Persistent link   https://www.medvik.cz/link/bmc24013543

Grant support
101103655 Horizon 2020 Framework Programme

BACKGROUND: Chemotherapy with lomustine is widely considered as standard treatment option for progressive glioblastoma. The value of adding radiotherapy to second-line chemotherapy is not known. METHODS: EORTC-2227-BTG (LEGATO, NCT05904119) is an investigator-initiated, pragmatic (PRECIS-2 score: 34 out of 45), randomized, multicenter phase III trial in patients with first progression of glioblastoma. A total of 411 patients will be randomized in a 1:1 ratio to lomustine (110 mg/m2 every 6 weeks) or lomustine (110 mg/m2 every 6weeks) plus radiotherapy (35 Gy in 10 fractions). Main eligibility criteria include histologic confirmation of glioblastoma, isocitrate dehydrogenase gene (IDH) wild-type per WHO 2021 classification, first progression at least 6 months after the end of prior radiotherapy, radiologically measurable disease according to RANO criteria with a maximum tumor diameter of 5 cm, and WHO performance status of 0-2. The primary efficacy endpoint is overall survival (OS) and secondary endpoints include progression-free survival, response rate, neurocognitive function, health-related quality of life, and health economic parameters. LEGATO is funded by the European Union's Horizon Europe Research program, was activated in March 2024 and will enroll patients in 43 sites in 11 countries across Europe with study completion projected in 2028. DISCUSSION: EORTC-2227-BTG (LEGATO) is a publicly funded pragmatic phase III trial designed to clarify the efficacy of adding reirradiation to chemotherapy with lomustine for the treatment of patients with first progression of glioblastoma. TRIAL REGISTRATION: ClinicalTrials.gov NCT05904119. Registered before start of inclusion, 23 May 2023.

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$a Kazda, Tomáš $u Department of Radiation Oncology and Research Centre for Applied Molecular Oncology (RECAMO), Masaryk Memorial Cancer Institute, Brno, Czech Republic
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$a Le Rhun, Emilie $u Department of Medical Oncology and Hematology, University Hospital & University of Zurich, Zurich, Switzerland
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$a Sahm, Felix $u Department of Neuropathology, University Hospital Heidelberg and CCU Neuropathology, DKFZ, Heidelberg, Germany
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$a Koekkoek, Johan Af $u Department of Neurology, Leiden University Medical Centre, Leiden, The Netherlands
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$a Monti, Angelo F $u Department of Medical Physics, ASST GOM Niguarda, Milano, Italy
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$a Csanadi, Marcell $u Syreon Research Institute, Budapest, Hungary
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$a Pitter, János György $u Syreon Research Institute, Budapest, Hungary
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$a Bulbek, Helen $u Brainstrust-the brain cancer people, Isle of Wight, Cowes, UK
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