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Irinotecan and Temozolomide + Standard Chemotherapy in Newly Diagnosed Ewing Sarcoma
NCT01864109Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- May 2013
- Primary completion
- May 2027
- Countries
- 1
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Modality
- Nanoparticles, Monoclonal Antibodies, Small Molecules
- Conditions
- Ewing sarcoma
01
Overview
Phase 2, open-label trial of irinotecan hydrochloride liposome injection (II) + temozolomide + bevacizumab and temozolomide in Ewing sarcoma (2 arms), sponsored by Memorial Sloan Kettering Cancer Center. Primary endpoint: Event-Free Survival at 4 years. Started May 2013; status: active, not recruiting.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
Patients with localized disease
Patients with localized disease will receive six cycles of the combination as maintenance therapy following standard chemotherapy.
Patients with metastatic disease
Patients will get 10 cycles of the combination intercalated between the final 4 cycles of standard chemotherapy.
03
Who it enrols
Patients aged 1-40 with newly diagnosed, previously untreated Ewing sarcoma, with adequate hematologic, renal, hepatic, and cardiac function.
04
Endpoints
Primary
Event-Free Survival
Secondary
Event-Free Survival
Adverse Events
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