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dc.contributor.authorAnderton, Jennifer
dc.contributor.authorMoroz, Veronica
dc.contributor.authorMarec-Bérard, Perrine
dc.contributor.authorGaspar, Nathalie
dc.contributor.authorLaurence, Valerie
dc.contributor.authorMartín-Broto, Javier
dc.contributor.authorSastre, Ana
dc.contributor.authorGelderblom, Hans
dc.contributor.authorOwens, Cormac
dc.contributor.authorKaiser, Sophie
dc.contributor.authorFernández-Pinto, Melissa
dc.contributor.authorFenwick, Nicola
dc.contributor.authorEvans, Abigail
dc.contributor.authorStrauss, Sandra
dc.contributor.authorWhelan, Jeremy
dc.contributor.authorWheatley, Keith
dc.contributor.authorBrennan, Bernadette
dc.date.accessioned2021-05-28T16:25:58Z
dc.date.available2021-05-28T16:25:58Z
dc.date.issued2020-01-17
dc.identifier.pmid31952545
dc.identifier.doi10.1186/s13063-019-4026-8
dc.identifier.urihttp://hdl.handle.net/10147/629532
dc.description.abstractBackground: Although there have been multiple randomised trials in newly diagnosed Ewing sarcoma family of tumours (ESFT) and these have been conducted over many years and involved many international cooperative groups, the outcomes for all stages of disease have plateaued. Internationally, the standard treatment of ESFT is not defined, and there is a need to add new agents other than conventional chemotherapy to improve outcomes. This trial will compare two different induction/consolidation chemotherapy regimens: (1) vincristine, ifosfamide, doxorubicin and etoposide (VIDE) induction and vincristine, actinomycin D, ifosfamide or cyclophosphamide, or busulfan and mephalan (VAI/VAC/BuMel) consolidation and (2) vincristine, doxorubicin, cyclophosphamide, ifosfamide and etoposide (VDC/IE) induction and ifosfamide and etoposide, vincristine and cyclophosphamide, vincristine, actinomycin D and ifosfamide, or busulfan and mephalan (IE/VC/VAI/BuMel) consolidation (randomisation 1, or R1). A second randomisation (R2) will determine whether the addition of zoledronic acid to consolidation chemotherapy, as assigned at R1, is associated with improved clinical outcome. Methods: EURO EWING 2012 is an international, multicentre, phase III, open-label randomised controlled trial. There are two randomisations: R1 and R2. Patients are randomly assigned at two different time points: at entry to the trial (R1) and following local control therapy (R2). The primary outcome measure is event-free survival. The secondary outcome measures include overall survival, adverse events and toxicity, histological response of the primary tumour, response of the primary tumour, regional lymph nodes or metastases (or both), and achievement of local control at the end of treatment. Discussion: This study will establish which is the "standard regimen" of chemotherapy, taking into account both clinical outcomes and toxicity. This will form the chemotherapy backbone for future interventional studies where we may want to add new targeted agents. It will also determine the role of zoledronic acid in conjunction with the separate EE2008 trial. Any trial in ESFT needs to take into account the rarity of the tumour and consider that international cooperation is needed to provide answers in a timely manner.en_US
dc.language.isoenen_US
dc.subjectEwing sarcoma family of tumoursen_US
dc.subjectRandomised controlled trialen_US
dc.subjectONCOLOGYen_US
dc.subjectCANCERen_US
dc.subjectCHEMOTHERAPYen_US
dc.titleInternational randomised controlled trial for the treatment of newly diagnosed EWING sarcoma family of tumours - EURO EWING 2012 Protocol.en_US
dc.typeArticleen_US
dc.typeOtheren_US
dc.identifier.eissn1745-6215
dc.identifier.journalTrialsen_US
dc.description.peer-reviewpeer-reviewen_US
dc.source.journaltitleTrials
dc.source.volume21
dc.source.issue1
dc.source.beginpage96
dc.source.endpage
refterms.dateFOA2021-05-28T16:25:58Z
dc.source.countryUnited Kingdom
dc.source.countryEngland


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