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An Open-label, Multi-center, Randomized Study of the Safety and Effect on Event-free Survival of Bevacizumab in Combination With Standard Chemotherapy in Childhood and Adolescent Patients With Metastatic Rhabdomyosarcoma and Non-rhabdomyosarcoma Soft Tissue Sarcoma

Trial Profile

An Open-label, Multi-center, Randomized Study of the Safety and Effect on Event-free Survival of Bevacizumab in Combination With Standard Chemotherapy in Childhood and Adolescent Patients With Metastatic Rhabdomyosarcoma and Non-rhabdomyosarcoma Soft Tissue Sarcoma

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 25 Apr 2023

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At a glance

  • Drugs Bevacizumab (Primary) ; Cyclophosphamide; Dactinomycin; Doxorubicin; Ifosfamide; Vincristine; Vinorelbine
  • Indications Ewing's sarcoma; Rhabdomyosarcoma; Sarcoma; Soft tissue sarcoma
  • Focus Therapeutic Use
  • Acronyms BERNIE
  • Sponsors Roche

Most Recent Events

  • 12 Apr 2023 Results (n=61; from July 2008 to December 2016) assessing the clinical behavior of pediatric non-rhabdomyosarcoma soft tissue sarcomas with distant metastases at onset pediatric adult-type metastatic NRSTS enrolled in the randomized BERNIE study and the single-arm MTS 2008 study, published in the Cancer.
  • 16 Jun 2022 Results of pooled analysis of MTS 2008 study and this study was published in the Journal of Clinical Oncology.
  • 13 Mar 2020 Results (n=49; data cutoff date: 31 May 2015) of primary efficacy analysis of a cohort of paediatric patients with metastatic non-rhabdomyosarcoma soft tissue sarcoma were published in the European Journal of Cancer

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