Non metastatic osteosarcoma of the extremities MedDRA version: 14.0 Level: PT Classification code 10031293 Term: Osteosarcoma localised System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: METHOTREXATE*INIET 1FL 1G 10ML
Pharmaceutical Form: Concentrate for solution for infusion
Concentration unit: gm/m2 gram(s)/square meter
Concentration type: up to
Concentration number: 12-
Sponsors
ITALIAN SARCOMA GROUP
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Primary
| Measure | Time frame |
|---|---|
| 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) To assess the survival in patient who do not over express ABCB1/P-glycoprotein, treated with a 3-drugs regimen (methotrexate, cisplatinum and doxorubicine) | — |
Countries
Italy
Contacts
Public ContactUfficio studi Clinici
Italian Sarcoma Group
Outcome results
None listed