Ewing's Sarcoma (ES)
Conditions
Brief 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
Interventions
DRUGTEMIRI
Window therapy frontline for VHR patients
DRUGADM
Drug used in the Induction phase in association with Vincristine, Ifosfamide, cyclophosphamide and Etoposide
DRUGIFO
Drug used in the Induction phase in association with Vincristine, Adriamycin, cyclophosphamide and Etoposide
DRUGCYC
Drug used in the Induction phase in association with Vincristine, Ifosfamide, Adriamycin and Etoposide
DRUGETO
Drug used in the Induction phase in association with Vincristine, Ifosfamide, cyclophosphamide and Adriamycin
DRUGBUMEL
Consolidation phase
DRUGVIN
Drug used in the Induction phase in association with cyclophosphamide , Ifosfamide, Adriamycin and Etoposide
Sponsors
Italian Sarcoma Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Expected average 3 year | Evaluation of the OS in patients treated according to the protocol |
| Event Free Survival (DFS) | Expected average 1 year | Evaluation of the time in which the patient do not experience any progression, relapse of toxicity event when treated according to the protocol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety - Incidence and grade of treatment-emergent Adverse Events | every 21 days up to 1 year | Incidence and grade of treatment-emergent Adverse Events |
| 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 | Evaluation of patient's Quality of life: comparison of the Baseline and On treatrment quality of life score using PedQL |
| 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 | Evaluation of patient's Quality of life: comparison of the Baseline and On treatrment quality of life score using EORTC QLQ-C30 |
Countries
Italy
Outcome results
None listed