Clinical trial NCT02727387: Protocol for the Treatment of Metastatic Ewing Sarcoma
Official title: Study With High Doses of Chemotherapy, Radiotherapy and Consolidation Therapy With Ciclofosfamide and Anticyclooxygenase 2, for the Metastatic Ewing Sarcoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ewing's Sarcoma (ES)
Lead sponsor: Italian Sarcoma Group
Sponsor class: NETWORK
First posted: 2016-04-04
Enrollment: 155
Sex: ALL
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Expected average 3 year
measure: Event Free Survival (DFS)
timeFrame: Expected average 1 year
Secondary outcomes:
measure: Safety - Incidence and grade of treatment-emergent Adverse Events
timeFrame: every 21 days up to 1 year
measure: Evaluation of Quality of life using Pediatric Quality of Life Inventory (PedQL) -in child and adolescents(EORTC QLQ-C30) for children and adolescents
timeFrame: every 3 weeks for the first 6 months and 3 monthly up to 1 year
measure: 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
timeFrame: every 3 weeks for the first 6 months and 3 monthly up to 1 year
Other outcomes:
Locations:
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico - Unit of Medical Oncology
state: Pordenone
city: Candiolo
country: Italy
facility: I.R.C.C. - Unit of Medical Oncology
state: Torino
city: Bari
country: Italy
facility: Azienda ospedaliero universitaria consorziale policlinico - bari
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors
city: Cagliari
country: Italy
facility: Servizio di Oncoematologi Pediatrica Ospedale microcitemico ASL 8
city: Firenze
country: Italy
facility: A.O. Universitaria Meyer
city: Genova
country: Italy
facility: Istituto Giannina Gaslini
city: Milano
country: Italy
facility: Fondazione IRCCS INT Milano
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana
city: Roma
country: Italy
facility: Ospedale Pediatrico Bambin Gesu'
city: Torino
country: Italy
facility: Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology
city: Trieste
country: Italy
facility: IRCCS materno infantile Burlo Garofolo
Study officials:
affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
name: Roberto Luksch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Picci P, Bohling T, Bacci G, Ferrari S, Sangiorgi L, Mercuri M, Ruggieri P, Manfrini M, Ferraro A, Casadei R, Benassi MS, Mancini AF, Rosito P, Cazzola A, Barbieri E, Tienghi A, Brach del Prever A, Comandone A, Bacchini P, Bertoni F. Chemotherapy-induced tumor necrosis as a prognostic factor in localized Ewing's sarcoma of the extremities. J Clin Oncol. 1997 Apr;15(4):1553-9. doi: 10.1200/JCO.1997.15.4.1553.
citation: Gardner SL, Carreras J, Boudreau C, Camitta BM, Adams RH, Chen AR, Davies SM, Edwards JR, Grovas AC, Hale GA, Lazarus HM, Arora M, Stiff PJ, Eapen M. Myeloablative therapy with autologous stem cell rescue for patients with Ewing sarcoma. Bone Marrow Transplant. 2008 May;41(10):867-72. doi: 10.1038/bmt.2008.2. Epub 2008 Feb 4.
citation: Paulussen M, Ahrens S, Burdach S, Craft A, Dockhorn-Dworniczak B, Dunst J, Frohlich B, Winkelmann W, Zoubek A, Jurgens H. Primary metastatic (stage IV) Ewing tumor: survival analysis of 171 patients from the EICESS studies. European Intergroup Cooperative Ewing Sarcoma Studies. Ann Oncol. 1998 Mar;9(3):275-81. doi: 10.1023/a:1008208511815.