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

Diagnosis

• Sarcomas
• Solid Tumors
• Malignant neoplasm of other connective and soft tissue

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)

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Responsibilities in overall trial

Sponsor

Westfälische Wilhelms-Universität Münster

National Coordinating Investigator

Prof. Dr. med. Uta Dirksen

Study Sites