Protocol for the Treatment of Metastatic Ewing Sarcoma
Palavras-chave
Resumo
Descrição
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
datas
| Última verificação: | 01/31/2020 |
| Enviado pela primeira vez: | 03/22/2016 |
| Inscrição estimada enviada: | 03/31/2016 |
| Postado pela primeira vez: | 04/03/2016 |
| Última atualização enviada: | 02/11/2020 |
| Última atualização postada: | 02/12/2020 |
| Data real de início do estudo: | 05/31/2009 |
| Data Estimada de Conclusão Primária: | 11/29/2021 |
| Data Estimada de Conclusão do Estudo: | 11/29/2021 |
Condição ou doença
Intervenção / tratamento
Drug: TEMIRI+VIN+ADM+IFO+ CYC+ETO+BUMEL
Drug: TEMIRI+VIN+ADM+IFO+ CYC+ETO+BUMEL
Drug: TEMIRI+VIN+ADM+IFO+ CYC+ETO+BUMEL
Drug: TEMIRI+VIN+ADM+IFO+ CYC+ETO+BUMEL
Drug: TEMIRI+VIN+ADM+IFO+ CYC+ETO+BUMEL
Drug: TEMIRI+VIN+ADM+IFO+ CYC+ETO+BUMEL
Drug: TEMIRI+VIN+ADM+IFO+ CYC+ETO+BUMEL
Fase
Grupos de Armas
| Braço | Intervenção / tratamento |
|---|---|
| Experimental: TEMIRI+VIN+ADM+IFO+ CYC+ETO+BUMEL 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) | Drug: TEMIRI+VIN+ADM+IFO+ CYC+ETO+BUMEL Window therapy frontline for VHR patients |
Critério de eleição
| Sexos elegíveis para estudo | All |
| Aceita Voluntários Saudáveis | sim |
| Critério | 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 |
Resultado
Medidas de Resultado Primário
1. Overall Survival (OS) [Expected average 3 year]
2. Event Free Survival (DFS) [Expected average 1 year]
Medidas de Resultado Secundário
1. Safety - Incidence and grade of treatment-emergent Adverse Events [every 21 days up to 1 year]
2. Evaluation of Quality of life using Pediatric Quality of Life Inventory (PedQL) -in child and adolescents(EORTC QLQ-C30) for children and adolescents [every 3 weeks for the first 6 months and 3 monthly up to 1 year]
3. Evaluation of Quality of life using European Organisation for Research and Treatment of Cancer Quality of Life of Cancer Patients (EORTC QLQ-C30) for adult patients [every 3 weeks for the first 6 months and 3 monthly up to 1 year]
