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

Italian Sarcoma Group

Status and phase

Completed

Phase 2

Conditions

Osteosarcoma

Treatments

Other: 3 drugs arm

Drug: Mifamurtide arm

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT01459484

ISG/OS-2

2011-001659-36 (EudraCT Number)

Details and patient eligibility

About

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

Full description

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

Enrollment

225 patients

Sex

All

Ages

Under 40 years old

Volunteers

No Healthy Volunteers

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