225
Participants
Start Date
June 23, 2011
Primary Completion Date
April 30, 2024
Study Completion Date
April 30, 2024
Mifamurtide arm
"PRE SUGERY TREATMENT:~Methotrexate: 12g/m2 (3 cycles) Cisplatinum: 120mg/m2 (3 cycles) Doxorubicin: ADM 75mg/m2 (3 cycles)~POST SURGERY TREATMENT for good responder patients with positive P-GLYCOPROTEIN~Methotrexate 12g/m2 (10 Cycles) Cisplatinum 120mg/m2; Doxorubicin 90mg/m2 MEPACT 2 mg/m2 twice a week for the first 3 months the weekly for the next 6 months (total lenght treatment 44 weeks)~POST SURGERY TREATMENT for poor responder patients with positive P-GLYCOPROTEIN~Methotrexate 12g/m2; Cisplatinum 120mg/m2; Doxorubicin 90mg/m2 ifosfamide 15g/m2 MEPACT 2 mg/m2 twice a week for the first 3 months the weekly for the next 6 months (total lenght treatment 44 weeks)~All the product are used as commercial formulation"
3 drugs arm
"High grade osteosarcoma who do not over express ABCB1/P-glycoprotein will be treated with a standard 3-drugs regimen~PRE-SUGERY TREATMENT:~Methotrexate: 12g/m2 (3 cycles) Cisplatinum: 120mg/m2 (3 cycles) Doxorubicin: ADM 75mg/m2 (3 cycles)~POST SURGERY TREATMENT:~Methotrexate 12g/m2 (10 cycles) Cisplatinum 120mg/m2; Doxorubicin 90mg/m2~Total lenght 34 weeks~All the product are used as commercial formulation"
I.R.C.C. - Unit of Medical Oncology, Candiolo
Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology, Torino
Presidio Sanitario Gradenigo, Torino
IRCCS Istituto ortopedico Rizzoli, Bologna
A.O. Universitaria Meyer, Florence
"Istituto Nazionale Tumori Fondazione G. Pascale", Napoli
Istituto Giannina Gaslini, Genova
FONDAZIONE IRCCS Istituto Nazionale dei Tumori, Milan
Azienda Ospedaliera di Padova, Padua
Istituti Fisioterapici Ospitalieri di Roma, Roma
Ospedale Pediatrico Bambin Gesu', Roma
Italian Sarcoma Group
NETWORK