Protocol for the Treatment of Metastatic Ewing Sarcoma (EW-2)

Italian Sarcoma Group

Status and phase: Completed; Phase 2

Conditions: Ewing's Sarcoma (ES)

Treatments: Drug: VIN; Drug: TEMIRI; Drug: ADM; Drug: BUMEL; Drug: ETO; Drug: CYC; Drug: IFO

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02727387

ISG/AIEOP EW-2

Details and patient eligibility

About

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

Full 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

Enrollment: 155 patients

Sex: All

Ages: Under 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically proven Ewing's sarcoma
• Age ≤ 40 years
• No previous treatment
• Multiple skeletal metastasis or bone marrow infiltration , with/without lung/pleural metastasis
• Signed Informed Consent

Exclusion criteria

• Localized Ewing's sarcoma
• Any contraindications to the study treatment
• Female patients who not accept to use an effective birth control method.
• Pregnant or breast-feeding patients

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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155 participants in 1 patient group

TEMIRI+VIN+ADM+IFO+ CYC+ETO+BUMEL

Experimental group

Description:

2cycles of Temozolomide(500 mg/m2)+Irinotecan(250 mg/m2) and 2cycles of Vincristine(1.4mg/m2)+ Adriamycin(90mg/m2)+Ifosfamide (9gr/m2) alternes with 2 cycles of Ciclofosfamide(4g/m2)+Etoposide (600mg/m2) followed by radiotherapy (42-54 Gy) and 2cycles of Ifosfamide (9gr/m2) + Etoposide(300mg/m2) alternes with to 2cycles of Vincristine (1.4mg/m2)+ Adriamycin (80mg/m2)+ Ciclofosfamide(1.2g/m2) and Busulfan(0.8-1.2 mg/Kg)+Melfalan(140 mg/m2)+PBSCT and 6 months with Celecoxib (500mg/m2/die for\<14 years old ,800 mg/die for\>14 years old) Ciclofosfamide (oral therapy 35mg/m2/die for\<14 years old, 50 mg/m2 for\>14 years old)

Treatment:

Drug: CYC

Drug: IFO

Drug: ETO

Drug: BUMEL

Drug: ADM

Drug: TEMIRI

Drug: VIN