At a glance
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Phase 3, Open Label, Multi-centre, Randomised Controlled International Study in Ewing Sarcoma
In Brief
A Phase 3 clinical trial evaluating Zoledronic acid, Busulfan, and 1 other intervention for Ewing's Sarcoma. Completed, enrolled 907 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
intravenously at 28 day intervals beginning with cycle 6 of VAC/VAI consolidation chemotherapy for a total period of nine months. Patients \< 18 years will receive 0.05 mg/kg BW by IV infusion 30 min-1 h. Patients \>= 18 years will receive a bodyweight-dependent dose: Patients \>40kg receive 4 mg by IV infusion 30 min-1h Patients 20-40 kg receive 2 mg by IV infusion 30 min-1h
intravenously, day -6 to d -3 adults: 0.8 mg/kg body weight (BW) children and adolescents: \<9 kg= 1mg/kg BW 9 - \<16 kg= 1.2 mg/kg BW 16 - 23 kg= 1.1 mg/kg BW \>23 - 34 kg= 0.95 mg/kg BW \>34 kg = 0.8 mg/kg BW
12 g/m² d-5 to d-3