se of biological marker (ABCB1/P-glycoprotein) as factor able to distinguish patients having different risk of recurrence in osteosarcoma

Conditions: on metastatic osteosarcoma of the extremities
MedDRA version: 14.0Level: PTClassification code 10031293Term: Osteosarcoma localisedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2011-001659-36-IT

Lead Sponsor: ITALIAN SARCOMA GROUP

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 225

Inclusion Criteria

Histology confirmed diagnosis of extremities high grade osteosarcoma,
Age = 40 years, Localized disease or presence of skip metastasis, Epatic, renal and bone marrow normal function,
LVEF > 50%, No previous surgery and/ or chemotherapic osteosarcoma treatments, No more than 4 weeks interval between histological diagnosis and start of chemotherapy,
Informed consent to the study participation obtained.
Are the trial subjects under 18? yes
Number of subjects for this age range: 146
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 79
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the survival in patient with non metastatic osteosarcoma of the extremities treated with different chemotherapy protocols, according to the expression of ABCB1/P-glycoprotein;Primary end point(s): Overall survival;Timepoint(s) of evaluation of this end point: The overall survival will be evaluated at the end of study period (5 enrollment years and 2 years miminum follow-up from the last enrolled patient);Secondary Objective: To assess the survival in patient who over express ABCB1/P-glycoprotein, with chemotherapy protocol based on all the 5 available active drugs (Methotrexate, cisplatinum, doxorubicine, ifosfamide and mifamurtide)<br>To assess the survival in patient who do not over express ABCB1/P-glycoprotein, treated with a 3-drugs regimen (methotrexate, cisplatinum and doxorubicine)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Events free survival in patient with ABCB1/P-glycoprotein over-expression, and who do not over-express ABCB1/P-glycoprotein.;Timepoint(s) of evaluation of this end point: The events free survival will be evaluated by means of interim analysis after 2 and 3 years from the start of study. A further evaluation will be performed at the end of enrollment and after 2 years form the last enrolled patient.