Protocol for the Treatment of Metastatic Ewing Sarcoma
- Registration Number
- NCT02727387
- Lead Sponsor
- Italian Sarcoma Group
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 155
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TEMIRI+VIN+ADM+IFO+ CYC+ETO+BUMEL ADM 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) TEMIRI+VIN+ADM+IFO+ CYC+ETO+BUMEL ETO 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) TEMIRI+VIN+ADM+IFO+ CYC+ETO+BUMEL VIN 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) TEMIRI+VIN+ADM+IFO+ CYC+ETO+BUMEL TEMIRI 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) TEMIRI+VIN+ADM+IFO+ CYC+ETO+BUMEL CYC 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) TEMIRI+VIN+ADM+IFO+ CYC+ETO+BUMEL 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) TEMIRI+VIN+ADM+IFO+ CYC+ETO+BUMEL IFO 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)
- Primary Outcome Measures
Name Time Method 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
Overall Survival (OS) Expected average 3 year Evaluation of the OS in patients treated according to the protocol
- Secondary Outcome Measures
Name Time Method 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
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 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
Trial Locations
- Locations (13)
Azienda Ospedaliero-Universitaria Pisana
🇮🇹Pisa, Italy
Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology
🇮🇹Torino, Italy
Centro di Riferimento Oncologico - Unit of Medical Oncology
🇮🇹Aviano, Pordenone, Italy
Azienda ospedaliero universitaria consorziale policlinico - bari
🇮🇹Bari, Italy
Servizio di Oncoematologi Pediatrica Ospedale microcitemico ASL 8
🇮🇹Cagliari, Italy
Istituto Ortopedico Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors
🇮🇹Bologna, Italy
A.O. Universitaria Meyer
🇮🇹Firenze, Italy
I.R.C.C. - Unit of Medical Oncology
🇮🇹Candiolo, Torino, Italy
Istituto Giannina Gaslini
🇮🇹Genova, Italy
Fondazione IRCCS INT Milano
🇮🇹Milano, Italy
Azienda Ospedaliera di Padova
🇮🇹Padova, Italy
IRCCS materno infantile Burlo Garofolo
🇮🇹Trieste, Italy
Ospedale Pediatrico Bambin Gesu'
🇮🇹Roma, Italy