ABCB1/P-glycoprotein Expression Influence on Non-metastatic Osteosarcoma of the Extremities

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteosarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Sarcoma

Age range

12 year–30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, A Coruña, Spain

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Confirmed histological diagnosis of high-grade osteosarcoma of the extremities.
Age: from 2 to 30 years old.
Localized disease (metastasis skip accepted).
Normal liver, kidney and spinal function.
Ventricular ejection fraction of 50%.
Absence of previous surgical treatments or chemotherapy for osteosarcoma.
Interval between histological diagnosis and initiation of chemotherapy not exceeding 4 weeks.
Signing of the consent form to participate in the study.

Exclusion criteria

Presence of lung metastases on chest CT or in other locations.
Parosteal, periosteal, or secondary osteosarcoma.
Contraindications of the medications prescribed in the protocol.
Pregnant or lactating.
Mental or social conditions that do not guarantee adequate adherence to the protocol.
Not having an adequate understanding of study participation.

Treatment and study plan

Primary outcomes

Overall Survival

Time frame: The patients will be followed in term of Overall Survival, for all the study period (expected average: 7 years)

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)

Secondary outcomes

Events free survival

Time frame: After 2 and 3 years from the start of study

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.

Sponsors and collaborators

Lead sponsor

Grupo Espanol de Investigacion en Sarcomas

Other

Registry information

Official study 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

Important dates

Study start: 2014
Primary completion: 2020
Study completion: 2020
First posted: May 12, 2020
Registry last updated: Aug 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed