Efficacy of Dose Intensification in Patients With Non-metastatic Ewing Sarcoma

Summary

Controlled, randomized phase III study, with the intent of optimizing the treatment of not metastatic Ewing Sarcoma. The patients will be randomized into 2 arms: standard treatment vs intensive treatment. Both arms will receive an induction treatment followed by surgery (wherever is possible) and/or radiotherapy. The maintenance treatment will be different on the basis of the response to the induction treatment (good or poor)

Timeline

Start

2009-01-22

Primary completion

2022-04-14

Completion

2022-04-14

Publications

• Background S. Ferrari, T. Alvegard, R. Luksch, A. Tienghi, K. S. Hall, G. Bernini, A. Brach del Prever, P. Picci, G. Bacci, S. Smeland Non-metastatic Ewing's family tumors: High-dose chemotherapy with stem cell rescue in poor responder patients. Preliminary results of the Italian/Scandinavian ISG/SSG III protocol. J Clini Oncol, 2007 ASCO Annual Meeting Proceedings Vol 25 (June 20 Suppl), 2007: 10014
• Luksch R, Palmerini E, Milano GM, Paioli A, Asaftei S, Barretta F, Puma N, Cesari M, Tirtei E, Podda M, Pierobon M, Manzitti C, Ferraresi V, Tamburini A, Bertulli R, Di Pinto D, Mascarin M, Grignani G, Coccoli L, Rabusin M, De Leonardis F, Gambarotti M, Parafioriti A, Cammelli S, Vennarini S, Ferrari S, Donati DM, Bastoni S, Massimino M, Fagioli F, Ibrahim T. Intensified Induction Therapy for Newly Diagnosed, Localized Skeletal Ewing Sarcoma (ISG/AIEOP EW-1): A Randomized, Open-Label, Phase 3, Non-Inferiority Trial. Pediatr Blood Cancer. 2025 Apr;72(4):e31551. doi: 10.1002/pbc.31551. Epub 2025 Jan 20.

Drugs

Indications