ABCB1/P-glycoprotein Expression as Biologic Stratification Factor for Patients With Non Metastatic Osteosarcoma

PHASE2CompletedINTERVENTIONAL
Enrollment

225

Participants

Timeline

Start Date

June 23, 2011

Primary Completion Date

April 30, 2024

Study Completion Date

April 30, 2024

Conditions
Osteosarcoma
Interventions
DRUG

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"

OTHER

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"

Trial Locations (11)

10060

I.R.C.C. - Unit of Medical Oncology, Candiolo

10126

Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology, Torino

10153

Presidio Sanitario Gradenigo, Torino

40136

IRCCS Istituto ortopedico Rizzoli, Bologna

50139

A.O. Universitaria Meyer, Florence

80131

"Istituto Nazionale Tumori Fondazione G. Pascale", Napoli

Unknown

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

All Listed Sponsors
lead

Italian Sarcoma Group

NETWORK

NCT01459484 - ABCB1/P-glycoprotein Expression as Biologic Stratification Factor for Patients With Non Metastatic Osteosarcoma | Biotech Hunter | Biotech Hunter