NCT02727387

Protocol for the Treatment of Metastatic Ewing Sarcoma

Study With High Doses of Chemotherapy, Radiotherapy and Consolidation Therapy With Ciclofosfamide and Anticyclooxygenase 2, for the Metastatic Ewing Sarcoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: Italian Sarcoma Group · Network
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

Study for the treatment of metastatic Ewing sarcoma with high doses chemotherapy, radiotherapy and maintenance therapy.

Detailed description

Study for the treatment of Ewing metastatic sarcoma with and induction phase with Vincristine (VIN), Adriamycin (ADM), Ciclofosfamide(CYC), Ifosfamide(IFO), Etoposide(ETO) and radiotherapy (RT)followed by a consolidation phase with Busulfan and Melfalan (BUMEL) and Peripheral Blood Stem Cells Transplantation (PBSCT) and a subsequent maintenance phase with Ciclofosfamide and Celecoxib for High Risk (HR) patients. Very High Risk (VHR) patients will receive a prior frontline therapy with Temozolomide and Irinotecan (TEMIRI), while patient with lung metastasis only will undergo to total lung irradiation after PBSCT

Conditions

• Ewing's Sarcoma (ES)

Interventions

Type	Name	Description
DRUG	TEMIRI	Window therapy frontline for VHR patients
DRUG	ADM	Drug used in the Induction phase in association with Vincristine, Ifosfamide, cyclophosphamide and Etoposide
DRUG	IFO	Drug used in the Induction phase in association with Vincristine, Adriamycin, cyclophosphamide and Etoposide
DRUG	CYC	Drug used in the Induction phase in association with Vincristine, Ifosfamide, Adriamycin and Etoposide
DRUG	ETO	Drug used in the Induction phase in association with Vincristine, Ifosfamide, cyclophosphamide and Adriamycin
DRUG	BUMEL	Consolidation phase
DRUG	VIN	Drug used in the Induction phase in association with cyclophosphamide , Ifosfamide, Adriamycin and Etoposide

Timeline

• Start date: 2009-06-01
• Primary completion: 2022-04-29
• Completion: 2022-04-29
• First posted: 2016-04-04
• Last updated: 2022-09-19

Locations

13 sites across 1 country: Italy