Protocol for the Treatment of Metastatic Ewing Sarcoma

Ewing's Sarcoma (ES) Clinical Trial

— EW-2  

Official title:

Study With High Doses of Chemotherapy, Radiotherapy and Consolidation Therapy With Ciclofosfamide and Anticyclooxygenase 2, for the Metastatic Ewing Sarcoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02727387
• Other study ID #: ISG/AIEOP EW-2
• Status: Completed
• Phase: Phase 2
• Start date: June 1, 2009
• Est. completion date: April 29, 2022

Study information

• Verified date: September 2022
• Source: Italian Sarcoma Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: April 29, 2022
• Est. primary completion date: April 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Ewing's Sarcoma (ES)
• Sarcoma
• Sarcoma, Ewing

Intervention

Drug:
• TEMIRI
Window therapy frontline for VHR patients
• ADM
Drug used in the Induction phase in association with Vincristine, Ifosfamide, cyclophosphamide and Etoposide
• IFO
Drug used in the Induction phase in association with Vincristine, Adriamycin, cyclophosphamide and Etoposide
• CYC
Drug used in the Induction phase in association with Vincristine, Ifosfamide, Adriamycin and Etoposide
• ETO
Drug used in the Induction phase in association with Vincristine, Ifosfamide, cyclophosphamide and Adriamycin
• BUMEL
Consolidation phase
• VIN
Drug used in the Induction phase in association with cyclophosphamide , Ifosfamide, Adriamycin and Etoposide

Locations

Country	Name	City	State
Italy	Centro di Riferimento Oncologico - Unit of Medical Oncology	Aviano	Pordenone
Italy	Azienda ospedaliero universitaria consorziale policlinico - bari	Bari
Italy	Istituto Ortopedico Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors	Bologna
Italy	Servizio di Oncoematologi Pediatrica Ospedale microcitemico ASL 8	Cagliari
Italy	I.R.C.C. - Unit of Medical Oncology	Candiolo	Torino
Italy	A.O. Universitaria Meyer	Firenze
Italy	Istituto Giannina Gaslini	Genova
Italy	Fondazione IRCCS INT Milano	Milano
Italy	Azienda Ospedaliera di Padova	Padova
Italy	Azienda Ospedaliero-Universitaria Pisana	Pisa
Italy	Ospedale Pediatrico Bambin Gesu'	Roma
Italy	Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology	Torino
Italy	IRCCS materno infantile Burlo Garofolo	Trieste

Sponsors (1)

Lead Sponsor	Collaborator
Italian Sarcoma Group

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View Citation

Paulussen M, Ahrens S, Burdach S, Craft A, Dockhorn-Dworniczak B, Dunst J, Fröhlich B, Winkelmann W, Zoubek A, Jürgens 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. — View Citation

Picci P, Böhling 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	Evaluation of the OS in patients treated according to the protocol	Expected average 3 year
Primary	Event Free Survival (DFS)	Evaluation of the time in which the patient do not experience any progression, relapse of toxicity event when treated according to the protocol	Expected average 1 year
Secondary	Safety - Incidence and grade of treatment-emergent Adverse Events	Incidence and grade of treatment-emergent Adverse Events	every 21 days up to 1 year
Secondary	Evaluation of Quality of life using Pediatric Quality of Life Inventory (PedQL) -in child and adolescents(EORTC QLQ-C30) for children and adolescents	Evaluation of patient's Quality of life: comparison of the Baseline and On treatrment quality of life score using PedQL	every 3 weeks for the first 6 months and 3 monthly up to 1 year
Secondary	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	Evaluation of patient's Quality of life: comparison of the Baseline and On treatrment quality of life score using EORTC QLQ-C30	every 3 weeks for the first 6 months and 3 monthly up to 1 year