Study in Localized and Disseminated Ewing Sarcoma

• Status: Completed
• Trial end date: 2019-03-31
• Target enrollment: 0
• Participant gender: All

Summary

Ewing Sarcoma

Primary objectives:

Standard Risk R1: in a randomised trial, to examine whether add-on treatment with zoledronic acid 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 <200 mL 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 poor histological response or tumour volume ≥200 mL (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.

*R2 accrual discontinued on December 1st 2015.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Muenster
• Treatments: Busulfan; Diphosphonates; Treosulfan; Zoledronic Acid

Criteria

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.

• Haematological parameters:

• Haemoglobin > 8 g/dl (transfusion allowed),

• Platelets > 80.000/µl (transfusion allowed),

• WBC > 2000/µl.

• Cardiac values: LVEF > 40%, SF > 28%.

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