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Trials in Progress

(P 538) IEUROEWING TRIAL FOR LOCALIZED AND METASTATIC EWING SARCOMA

Location: The Liffey, Level 1

    Author(s)

  • Uta Dirksen, MD

    Professor
    University Hospital Essen, Pediatrics III, West German Cancer Center, German Cancer Research Center (DKTK) site Essen, National Center for Tumordiseases (NCT) site Essen, ,
    Essen, Nordrhein-Westfalen, Germany

    • Co-Author(s)

  • Josephine Kersting, MD (she/her/hers)

    Medical Doctor
    Pediatrics III, University Hospital Essen, West German Cancer Center
    Duesseldorf, Nordrhein-Westfalen, Germany

  • SZ

    Stefan K. Zöllner, MD

    Pediatrics III, University Hospital Essen, West German Cancer Center
    Essen, Nordrhein-Westfalen, Germany

  • Beate Timmermann, MD (she/her/hers)

    Director of the Clinic of Particle Therapy, Medical head of West German Proton Therapy Centre Essen (WPE)
    University Hospital Essen
    Essen, Nordrhein-Westfalen, Germany

  • Dimosthenis Andreou, MD

    Division Chair Orthopaedic Oncology
    Medical University of Graz
    Graz, Steiermark, Austria

  • JH

    Jendrik Hardes, MD

    University Hospital Essen
    Essen, Nordrhein-Westfalen, Germany

  • AS

    Arne Streitbürger, MD

    Professor
    Sarcomasurgery, Oerthoredic Surgery, University Hospital Essen, West German Cancer Center, Essen
    Essen, Nordrhein-Westfalen, Germany

  • MM

    Markus Metzler, MD

    Professor
    Department of Pediatrics and Adolescent Medicine, University Hospital Erlangen
    Erlangen, Bayern, Germany

  • ET

    Eleni Tomazou, Dr.

    Principal Investigator
    Children’s Cancer Research Institute, St. Anna Kinderkrebsforschung, Vienna, Austria
    Vienna, Wien, Austria

  • DR

    Dirk Reinhardt, Professor, MD, PhD

    Executive DirectorGPOH gGmbH and Director Pediatrics III
    GPOH and University Hospital Essen
    Essen, Nordrhein-Westfalen, Germany

  • WH

    Wolfgang Hartmann, N/A, MD

    University Hospital Münster
    Münster, Nordrhein-Westfalen, Germany

  • Yasmin Uhlenbruch, MD

    St. Josef's Hospital Bochum
    Bochum, Nordrhein-Westfalen, Germany

  • GC

    Gabriele Calaminus, MD

    University Hospital Bonn
    Bonn, Nordrhein-Westfalen, Germany

  • AR

    Andreas Ranft, N/A, Dr.

    University Hospital Essen
    Essen, Nordrhein-Westfalen, Germany

Objective: The iEuroEwing trial is a prospective, randomized phase III trial of the European Ewing Sarcoma Group that represents an interdisciplinary treatment protocol jointly developed by European and other international Ewing sarcoma study groups. The primary goal is to improve survival of patients with Ewing sarcoma and related entities (hereafter EWS) by optimizing therapy. iEuroEwing poses three randomized questions in two risk arms, standard risk (SR) and high risk (HR). Systemic neo- and adjuvant polychemotherapy defines as standard intravenous combination therapy of vincristine, doxorubicin, and cyclophosphamide (VDC) alternating with ifosfamide and etoposide (IE).

Methods: The trial consist of two arms: the standard risk arm (SR arm) for patients with localized disease and the high risk arm (HR arm) for patients with primary metastatic disease .The first primary objective is to improve event-free survival (EFS) by introducing maintenance therapy in both the SR and HR B trial arms, randomizing an additive, 6-month maintenance therapy with vinorelbine and cyclophosphamide (VinoCyc).
The second primary objective in the SR group is to investigate whether, in the context of local therapy, intensification of the radiotherapy-applied dose in the primary tumor region is non-inferior with respect to the occurrence of toxicity (CTCAE grade ≥ 3) and secondary outcome.
The third primary objective is to convert the early response to chemotherapy into a long-term cure for EWS patients in the HR group by allowing additional targeted therapies in independently integrated phase II trials of which two biomarker-driven trials are .
Secondary objectives of the iEuroEwing trial are to improve local therapeutic control, event-free survival (EFS), and overall survival (OS) through risk-adjusted and dose-scaled radiotherapy, quality of life and collection of biomaterial and images. The iEuroEwing trial started in December 2022 with a 6.5-year enrollment period and a 2-year follow-up period for a total of 1018 expected patients in 13 Euroean and international countries. The iEuroEwing-led international trial center is the Cooperative Ewing Sarcoma Study (CESS) group. Sponsor of the trial is the Society for Pediatric Oncology and Hematology (GPOH gGmbH). iEuroEwing is funded by German Cancer Aid: DKH70113419 .

Results: N/A trial in progress

Conclusion: N/A trial in progress