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

ABCB1/P-glycoprotein Expression as Biologic Stratification Factor for Patients With Non Metastatic Osteosarcoma - Prospective Study (ISG/OS-2)

This is a phase II multicentre, uncontrolled trial including patients ≤ 40 years with non-metastatic extremity high-grade osteosarcoma stratified according to P-glicoprotein expression

The main objective of the study is to evaluate the impact on event-free survival (EFS) of a multi-drug chemotherapy approach and mifamurtide treatment in patients with non-metastatic osteosarcoma of the extremities according to the expression of ABCB1/P-glycoprotein

Inclusion Criteria:

• Histology confirmed diagnosis of extremities high grade osteosarcoma
• Age ≤ 40 years
• Localized disease or presence of skip metastasis
• Hepatic, renal and bone marrow normal function
• LVEF > 50%
• No previous surgery and/ or chemotheraputic osteosarcoma treatments,
• No more than 4 weeks interval between histological diagnosis and start of chemotherapy
• Informed consent to the study participation obtained.

Exclusion Criteria:

• Presence of metastases other than skip metastases
• Periosteal Osteosarcoma, parostal osteosarcoma, secondary osteosarcoma,
• Medical contra-indication to the drugs foreseen in the protocol,
• Subject is pregnant or breast feeding
• Mental or social conditions that can compromise a correct adherence to the protocol and its procedures