Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
155 participants
INTERVENTIONAL
2009-06-01
2022-04-29
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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)
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age ≤ 40 years
* No previous treatment
* Multiple skeletal metastasis or bone marrow infiltration , with/without lung/pleural metastasis
* Signed Informed Consent
Exclusion Criteria
* Any contraindications to the study treatment
* Female patients who not accept to use an effective birth control method.
* Pregnant or breast-feeding patients
40 Years
ALL
No
Sponsors
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Italian Sarcoma Group
NETWORK
Responsible Party
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Principal Investigators
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Roberto Luksch, MD
Role: PRINCIPAL_INVESTIGATOR
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Locations
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Centro di Riferimento Oncologico - Unit of Medical Oncology
Aviano, Pordenone, Italy
I.R.C.C. - Unit of Medical Oncology
Candiolo, Torino, 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
A.O. Universitaria Meyer
Florence, , Italy
Istituto Giannina Gaslini
Genova, , Italy
Fondazione IRCCS INT Milano
Milan, , Italy
Azienda Ospedaliera di Padova
Padua, , 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, , Italy
Countries
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References
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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.
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.
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.
Other Identifiers
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ISG/AIEOP EW-2
Identifier Type: -
Identifier Source: org_study_id
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