ABCB1/P-glycoprotein Expression as Biologic Stratification Factor for Patients With Non Metastatic Osteosarcoma - Prospective Study (ISG/OS-2)
The Primary objective is:
* Overall survival in patient with non metastatic osteosarcoma of the extremities treated
with different chemotherapy approach (5 drugs vs 3 drugs), according to the expression of
ABCB1/P-glycoprotein
The Secondary objectives are:
- 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
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Survival
The Overall Survival will be evaluated at the end of the study period (5 enrollment years and 2 years - minimum- follow-up from the last enrolled patient)
The patients will be followed in term of Overall Survival, for all the study period (expected average: 7 years)
No
Stefano Ferrari, MD
Principal Investigator
Italian Sarcoma Group
Italy: Ethics Committee
ISG/OS-2
NCT01459484
July 2011
July 2019
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