ABCB1/P-glycoprotein Expression Influence on Non-metastatic Osteosarcoma of the Extremities
-
- STATUS
- Recruiting
-
- participants needed
- 125
-
- sponsor
- Grupo Espanol de Investigacion en Sarcomas
Summary
Post-authorization, observational, multicenter and prospective study in patients between 2
and 30 years old diagnosed with non-metastatic high-grade
All patients included in the study will receive the initial
After
As an
- - If there is overexpression of
ABCB1 /P-glycoprotein and poor response toinduction treatment, in many sitesifosfamide at high doses and MTP-PE, is incorporated in addition toadriamycin . - - If there is overexpression of
ABCB1 /P-glycoprotein and a good response toinduction treatment, in many centers the option of additional administration ofmethotrexate ,CDDP andadriamycin will be chosen. - - If there is
no overexpression ofABCB1 /P-glycoprotein , the administration ofmethotrexate ,adriamycin andcisplatin will be chosen in many sites.
In some sites they will consider the non-administration of MTP-PE or the non-administration
of high doses of
Description
The Primary objective is:
- Disease-free survival measured as a 5-year rate in patients with localized
osteosarcoma treated, according to standard practice, with all thedrugs currently registered for the treatment of non-metastaticosteosarcoma (methotrexate ,cisplatin ,adriamycin ,ifosfamide , MTP-PE), according toABCB1 /P-glycoprotein expression.
The Secondary objectives are:
- Evaluate overall survival in a homogeneous population of patients with non-metastatic
osteosarcoma . - Disease-free survival at 2 and 3 years.
Details
| Condition |
|
|---|---|
| Age | 12years - 30years |
| Clinical Study Identifier | NCT04383288 |
| Sponsor | Grupo Espanol de Investigacion en Sarcomas |
| Last Modified on | 19 February 2024 |
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