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Klinische Studien

EWING 2008-Pädiatrie

AcronymISRCTNEudraCTNCT (clinicaltrials.gov)DRKS
EWING 20082008-003658-13NCT00987636

Study in Localized and Disseminated Ewing Sarcoma (EWING 2008)

Status: Active (Recruitment Closed)

Purpose / Objectives

Primary Outcome

  • Standard Risk R1: in a randomised trial, to examine whether add-on treatment with fenretinide or zoledronic acid, or zoledronic acid plus fenretinide in addition to induction and maintenance chemotherapy improves event-free survival in patients with localised Ewing sarcoma and good histological response or with initial tumour volume < 200ml compared to no add on treatment
  • High Risk R2: in a randomised trial, to examine whether high dose chemotherapy using busulfan-melphalan with autologous stem cell reinfusion, compared with standard chemotherapy, improves event-free survival in patients with localised Ewing sarcoma and unfavourable histological response or tumour volume>200ml (R2loc). In patients with pulmonary metastases high dose busulfan-melphalan chemotherapy with autologous stem cell reinfusion is randomised versus standard chemotherapy plus whole lung irradiation (R2pulm)
  • Very High Risk R3: in a randomised trial, to examine whether the addition of high dose chemotherapy using treosulfan-melphalan followed by autologous stem cell reinfusion to eight cycles of standard adjuvant chemotherapy, compared to eight cycles of standard adjuvant chemotherapy alone, improves event-free survival in patients with primary disseminated disease

Secondary Outcomes

  • Overall survival [ Time Frame: 6.5 years ]
  • safety and toxicity [ Time Frame: permanent ]
  • Quality of life [ Time Frame: 8.5 years ] [ Designated as safety issue: No ]
  • Diagnosis

    Ewing's sarcoma in childhood and adolescence

    Patient attributes

    Stage

    R1 to R3

    Inclusion criteria

    • Diagnosis: Histologically confirmed Ewing sarcoma of bone or soft tissue.
    • Age and sex: Either sex, age >48 months (for GPOH patients) and <50 years at the date of diagnostic biopsy. Younger or elderly patients may be reported to the appropriate office (see section 1.4) but are not included in this study.
    • Registration: ≤ 45 days after diagnostic biopsy/surgery.
    • Start of chemotherapy: ≤ 45 days after diagnostic biopsy/surgery.
    • Informed consent: Must be signed prior to study entry.
    • Performance status: Lansky or Karnofsky score > 50%, may be modified for handicapped patients.

    Exclusion criteria

    • More than one cycle of other chemotherapy prior to registration
    • Second malignancy
    • Pregnancy and lactation
    • Concurrent treatment within any other clinical trial, except trials with different endpoints that due to the nature of their endpoints must run parallel to EWING 2008 e.g. trials on antiemetics, antimycotics, antibiotics, strategies for psychosocial support, etc...
    • Any other medical, psychiatric, or social condition incompatible with protocol treatment

    Trial design

    • Phase III
    • Multicenter
    • Prospective
    • Randomized

    Intervention


    Miscellaneous


    Documents (password protected)

    Responsibilities in overall trial

    Westfälische Wilhelms-Universität Münster

      National Coordinating Investigator

      Prof. Dr. med. Uta Dirksen

      Study Sites

      Zentrum für Kinderheilkunde

      Study office

      • Pädiatrische Hämatologie/Onkologie

      Status

      Active (Recruitment Closed)

      Principal Investigator

      Prof. Dr. med. Dagmar Dilloo

      Subinvestigator

      • Dr. med. Gabriele Calaminus
      • Dr. med. Ina Hainmann

      Contact at Site

      Klinik und Poliklinik für Kinder- und Jugendmedizin

      Study office

      Status

      Active (Recruitment Closed)

      Principal Investigator

      Prof. Dr. med. Thorsten Simon

      Deputy of Principal Investigator

      • Prof. Dr. med. Matthias Fischer
      • Dr. med. Barbara Hero

      Subinvestigator

      • Dr. med. Rita Kiener
      • Dr. med. Diana Dworaczek, geb. Gomez Alcazar
      • Dr. med. Marc Hömberg
      • Dr. Annette Kramarczyk
      • Dr. med. Boris Decarolis
      • Dr. med. Pablo Landgraf
      • Dr. med. Claudia Potthoff

      Contact at Site

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