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Intensified Induction Therapy for Newly Diagnosed, Localized Skeletal Ewing Sarcoma (ISG/AIEOP EW-1): A Randomized, Open-Label, Phase 3, Non-Inferiority Trial.

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Title: Intensified Induction Therapy for Newly Diagnosed, Localized Skeletal Ewing Sarcoma (ISG/AIEOP EW-1): A Randomized, Open-Label, Phase 3, Non-Inferiority Trial.
Authors: Luksch R; Pediatric Oncology Unit and Biostatistics for Clinical Research Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy., Palmerini E; Osteoncology, Bone and Soft Tissue Sarcomas and Innovative Therapies Unit, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy., Milano GM; Division of Pediatric Hematology and Oncology, Gene and Cellular Therapy, IRCCS Ospedale Pediatrico Bambino Gesù, Rome, Italy., Paioli A; Osteoncology, Bone and Soft Tissue Sarcomas and Innovative Therapies Unit, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy., Asaftei S; Pediatric Onco-Hematology Department, A.O. Ospedale Infantile Regina Margherita, Turin, Italy., Barretta F; Pediatric Oncology Unit and Biostatistics for Clinical Research Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy., Puma N; Pediatric Oncology Unit and Biostatistics for Clinical Research Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy., Cesari M; Osteoncology, Bone and Soft Tissue Sarcomas and Innovative Therapies Unit, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy., Tirtei E; Pediatric Onco-Hematology Department, A.O. Ospedale Infantile Regina Margherita, Turin, Italy.; Department of Public Health and Pediatric Sciences, University of Turin, Turin, Italy., Podda M; Pediatric Oncology Unit and Biostatistics for Clinical Research Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy., Pierobon M; Pediatric Hematology, Oncology and Stem Cell Transplant Division, Azienda Ospedale - Università Padova, Padua, Italy., Manzitti C; Oncology Unit, IRCCS Istituto Giannina Gaslini, Genoa, Italy., Ferraresi V; Sarcomas and Rare Tumors Departmental, IRCCS Istituto Nazionale Tumori Regina Elena, Rome, Italy., Tamburini A; Department of Pediatric Oncohematology, Azienda Ospedaliero Universitaria Meyer IRCCS, Florence, Italy., Bertulli R; Pediatric Oncology Unit and Biostatistics for Clinical Research Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy., Di Pinto D; Pediatric Oncology and Hematology Department, AOU-Università della Campania 'Luigi Vanvitelli', Naples, Italy., Mascarin M; Radiotherapy Department, AYA Oncology and Pediatric Radioitherapy Unit, IRCCS Centro Riferimento Oncologico, Aviano, Italy., Grignani G; Medical Oncology Department, AOU Città della Salute e della Scienza di Turino, Turin, Italy., Coccoli L; Pediatric Oncology and Hematology Unit, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy., Rabusin M; Pediatric Onco-Hematology Department, IRCCS Materno Infantile Burlo Garofolo, Trieste, Italy., De Leonardis F; 'F.Vecchio' Pediatric Department, Policlinico Universitario, Bari, Italy., Gambarotti M; Osteoncology, Bone and Soft Tissue Sarcomas and Innovative Therapies Unit, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy., Parafioriti A; Pathology Division, ASST Gaetano Pini - CTO, Milan, Italy., Cammelli S; Radiation Oncology, IRCCS Azienda Ospedaliero - Universitaria di Bologna, Bologna, Italy.; Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy., Vennarini S; Pediatric Oncology Unit and Biostatistics for Clinical Research Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy., Ferrari S; Osteoncology, Bone and Soft Tissue Sarcomas and Innovative Therapies Unit, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy., Donati DM; Osteoncology, Bone and Soft Tissue Sarcomas and Innovative Therapies Unit, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.; Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy., Bastoni S; Pathology Division, ASST Gaetano Pini - CTO, Milan, Italy., Massimino M; Pediatric Oncology Unit and Biostatistics for Clinical Research Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy., Fagioli F; Pediatric Onco-Hematology Department, A.O. Ospedale Infantile Regina Margherita, Turin, Italy., Ibrahim T; Osteoncology, Bone and Soft Tissue Sarcomas and Innovative Therapies Unit, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.
Source: Pediatric blood & cancer [Pediatr Blood Cancer] 2025 Apr; Vol. 72 (4), pp. e31551. Date of Electronic Publication: 2025 Jan 20.
Publication Type: Clinical Trial, Phase III; Equivalence Trial; Journal Article; Multicenter Study; Randomized Controlled Trial
Journal Info: Publisher: John Wiley Country of Publication: United States NLM ID: 101186624 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1545-5017 (Electronic) Linking ISSN: 15455009 NLM ISO Abbreviation: Pediatr Blood Cancer Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Intensified Induction Therapy for Newly Diagnosed, Localized Skeletal Ewing Sarcoma (ISG/AIEOP EW-1): A Randomized, Open-Label, Phase 3, Non-Inferiority Trial.
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  Data: <searchLink fieldCode="AU" term="%22Luksch+R%22">Luksch R</searchLink>; Pediatric Oncology Unit and Biostatistics for Clinical Research Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.<br /><searchLink fieldCode="AU" term="%22Palmerini+E%22">Palmerini E</searchLink>; Osteoncology, Bone and Soft Tissue Sarcomas and Innovative Therapies Unit, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.<br /><searchLink fieldCode="AU" term="%22Milano+GM%22">Milano GM</searchLink>; Division of Pediatric Hematology and Oncology, Gene and Cellular Therapy, IRCCS Ospedale Pediatrico Bambino Gesù, Rome, Italy.<br /><searchLink fieldCode="AU" term="%22Paioli+A%22">Paioli A</searchLink>; Osteoncology, Bone and Soft Tissue Sarcomas and Innovative Therapies Unit, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.<br /><searchLink fieldCode="AU" term="%22Asaftei+S%22">Asaftei S</searchLink>; Pediatric Onco-Hematology Department, A.O. Ospedale Infantile Regina Margherita, Turin, Italy.<br /><searchLink fieldCode="AU" term="%22Barretta+F%22">Barretta F</searchLink>; Pediatric Oncology Unit and Biostatistics for Clinical Research Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.<br /><searchLink fieldCode="AU" term="%22Puma+N%22">Puma N</searchLink>; Pediatric Oncology Unit and Biostatistics for Clinical Research Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.<br /><searchLink fieldCode="AU" term="%22Cesari+M%22">Cesari M</searchLink>; Osteoncology, Bone and Soft Tissue Sarcomas and Innovative Therapies Unit, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.<br /><searchLink fieldCode="AU" term="%22Tirtei+E%22">Tirtei E</searchLink>; Pediatric Onco-Hematology Department, A.O. Ospedale Infantile Regina Margherita, Turin, Italy.; Department of Public Health and Pediatric Sciences, University of Turin, Turin, Italy.<br /><searchLink fieldCode="AU" term="%22Podda+M%22">Podda M</searchLink>; Pediatric Oncology Unit and Biostatistics for Clinical Research Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.<br /><searchLink fieldCode="AU" term="%22Pierobon+M%22">Pierobon M</searchLink>; Pediatric Hematology, Oncology and Stem Cell Transplant Division, Azienda Ospedale - Università Padova, Padua, Italy.<br /><searchLink fieldCode="AU" term="%22Manzitti+C%22">Manzitti C</searchLink>; Oncology Unit, IRCCS Istituto Giannina Gaslini, Genoa, Italy.<br /><searchLink fieldCode="AU" term="%22Ferraresi+V%22">Ferraresi V</searchLink>; Sarcomas and Rare Tumors Departmental, IRCCS Istituto Nazionale Tumori Regina Elena, Rome, Italy.<br /><searchLink fieldCode="AU" term="%22Tamburini+A%22">Tamburini A</searchLink>; Department of Pediatric Oncohematology, Azienda Ospedaliero Universitaria Meyer IRCCS, Florence, Italy.<br /><searchLink fieldCode="AU" term="%22Bertulli+R%22">Bertulli R</searchLink>; Pediatric Oncology Unit and Biostatistics for Clinical Research Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.<br /><searchLink fieldCode="AU" term="%22Di+Pinto+D%22">Di Pinto D</searchLink>; Pediatric Oncology and Hematology Department, AOU-Università della Campania 'Luigi Vanvitelli', Naples, Italy.<br /><searchLink fieldCode="AU" term="%22Mascarin+M%22">Mascarin M</searchLink>; Radiotherapy Department, AYA Oncology and Pediatric Radioitherapy Unit, IRCCS Centro Riferimento Oncologico, Aviano, Italy.<br /><searchLink fieldCode="AU" term="%22Grignani+G%22">Grignani G</searchLink>; Medical Oncology Department, AOU Città della Salute e della Scienza di Turino, Turin, Italy.<br /><searchLink fieldCode="AU" term="%22Coccoli+L%22">Coccoli L</searchLink>; Pediatric Oncology and Hematology Unit, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.<br /><searchLink fieldCode="AU" term="%22Rabusin+M%22">Rabusin M</searchLink>; Pediatric Onco-Hematology Department, IRCCS Materno Infantile Burlo Garofolo, Trieste, Italy.<br /><searchLink fieldCode="AU" term="%22De+Leonardis+F%22">De Leonardis F</searchLink>; 'F.Vecchio' Pediatric Department, Policlinico Universitario, Bari, Italy.<br /><searchLink fieldCode="AU" term="%22Gambarotti+M%22">Gambarotti M</searchLink>; Osteoncology, Bone and Soft Tissue Sarcomas and Innovative Therapies Unit, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.<br /><searchLink fieldCode="AU" term="%22Parafioriti+A%22">Parafioriti A</searchLink>; Pathology Division, ASST Gaetano Pini - CTO, Milan, Italy.<br /><searchLink fieldCode="AU" term="%22Cammelli+S%22">Cammelli S</searchLink>; Radiation Oncology, IRCCS Azienda Ospedaliero - Universitaria di Bologna, Bologna, Italy.; Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy.<br /><searchLink fieldCode="AU" term="%22Vennarini+S%22">Vennarini S</searchLink>; Pediatric Oncology Unit and Biostatistics for Clinical Research Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.<br /><searchLink fieldCode="AU" term="%22Ferrari+S%22">Ferrari S</searchLink>; Osteoncology, Bone and Soft Tissue Sarcomas and Innovative Therapies Unit, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.<br /><searchLink fieldCode="AU" term="%22Donati+DM%22">Donati DM</searchLink>; Osteoncology, Bone and Soft Tissue Sarcomas and Innovative Therapies Unit, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.; Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy.<br /><searchLink fieldCode="AU" term="%22Bastoni+S%22">Bastoni S</searchLink>; Pathology Division, ASST Gaetano Pini - CTO, Milan, Italy.<br /><searchLink fieldCode="AU" term="%22Massimino+M%22">Massimino M</searchLink>; Pediatric Oncology Unit and Biostatistics for Clinical Research Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.<br /><searchLink fieldCode="AU" term="%22Fagioli+F%22">Fagioli F</searchLink>; Pediatric Onco-Hematology Department, A.O. Ospedale Infantile Regina Margherita, Turin, Italy.<br /><searchLink fieldCode="AU" term="%22Ibrahim+T%22">Ibrahim T</searchLink>; Osteoncology, Bone and Soft Tissue Sarcomas and Innovative Therapies Unit, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.
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  Data: <searchLink fieldCode="JN" term="%22101186624%22">Pediatric blood & cancer</searchLink> [Pediatr Blood Cancer] 2025 Apr; Vol. 72 (4), pp. e31551. <i>Date of Electronic Publication: </i>2025 Jan 20.
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