Ignite Creation Date:
2024-05-06 @ 2:40 PM
Last Modification Date:
2024-10-26 @ 1:34 PM
Study NCT ID:
NCT04383288
Status:
COMPLETED
Last Update Posted:
2021-08-04
First Post:
2020-05-07
Brief Title:
ABCB1P-glycoprotein Expression Influence on Non-metastatic Osteosarcoma of the Extremities
Sponsor:
Grupo Espanol de Investigacion en Sarcomas
Organization:
Grupo Espanol de Investigacion en Sarcomas
Study Overview
Official Title:
Prospective Observational Study of the Expression of ABCB1 P-glycoprotein as a Factor for the Biological Stratification of Non-metastatic Osteosarcoma of the Extremities
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Post-authorization observational multicenter and prospective study in patients between 2 and 30 years old diagnosed with non-metastatic high-grade osteosarcoma of the extremities
All patients included in the study will receive the initial neoadjuvant treatment prescribed by the doctor of each center according to standard practice involving methotrexate cisplatin and adriamycin This initial treatment precedes surgical treatment
After surgical treatment the histological response to neoadjuvant chemotherapy will be evaluated The histological response to primary chemotherapy will be expressed as a percentage of tumor necrosis In the case of tumor necrosis above 90 the patient is defined as a good responder in case of a lower percentage as a poor responder
As an adjuvant treatment the following options may be given according to standard practice in each center
1 - If there is overexpression of ABCB1 P-glycoprotein and poor response to induction treatment in many sites ifosfamide at high doses and MTP-PE is incorporated in addition to adriamycin
2 - If there is overexpression of ABCB1 P-glycoprotein and a good response to induction treatment in many centers the option of additional administration of methotrexate CDDP and adriamycin will be chosen
3 - If there is no overexpression of ABCB1 P-glycoprotein the administration of methotrexate adriamycin and cisplatin 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 ifosfamide And in some hospitals they will consider administering MTP-PE to all patients
All patients included in the study will receive the initial neoadjuvant treatment prescribed by the doctor of each center according to standard practice involving methotrexate cisplatin and adriamycin This initial treatment precedes surgical treatment
After surgical treatment the histological response to neoadjuvant chemotherapy will be evaluated The histological response to primary chemotherapy will be expressed as a percentage of tumor necrosis In the case of tumor necrosis above 90 the patient is defined as a good responder in case of a lower percentage as a poor responder
As an adjuvant treatment the following options may be given according to standard practice in each center
1 - If there is overexpression of ABCB1 P-glycoprotein and poor response to induction treatment in many sites ifosfamide at high doses and MTP-PE is incorporated in addition to adriamycin
2 - If there is overexpression of ABCB1 P-glycoprotein and a good response to induction treatment in many centers the option of additional administration of methotrexate CDDP and adriamycin will be chosen
3 - If there is no overexpression of ABCB1 P-glycoprotein the administration of methotrexate adriamycin and cisplatin 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 ifosfamide And in some hospitals they will consider administering MTP-PE to all patients
Detailed 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 the drugs currently registered for the treatment of non-metastatic osteosarcoma methotrexate cisplatin adriamycin ifosfamide MTP-PE according to ABCB1 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
- Disease-free survival measured as a 5-year rate in patients with localized osteosarcoma treated according to standard practice with all the drugs currently registered for the treatment of non-metastatic osteosarcoma methotrexate cisplatin adriamycin ifosfamide MTP-PE according to ABCB1 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None