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

Osteosarcoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04383288
• Other study ID #: GEIS-33
• Status: Completed
• Start date: July 2, 2014
• Est. completion date: October 17, 2020

Study information

• Verified date: August 2021
• Source: Grupo Espanol de Investigacion en Sarcomas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: October 17, 2020
• Est. primary completion date: October 17, 2020
• Gender: All
• Age group: 12 Years to 30 Years

Eligibility

Inclusion Criteria:

1. Confirmed histological diagnosis of high-grade osteosarcoma of the extremities.

2. Age: from 2 to 30 years old.

3. Localized disease (metastasis skip accepted).

4. Normal liver, kidney and spinal function.

5. Ventricular ejection fraction of 50%.

6. Absence of previous surgical treatments or chemotherapy for osteosarcoma.

7. Interval between histological diagnosis and initiation of chemotherapy not exceeding 4 weeks.

8. Signing of the consent form to participate in the study.

Exclusion Criteria:

1. Presence of lung metastases on chest CT or in other locations.

2. Parosteal, periosteal, or secondary osteosarcoma.

3. Contraindications of the medications prescribed in the protocol.

4. Pregnant or lactating.

5. Mental or social conditions that do not guarantee adequate adherence to the protocol.

6. Not having an adequate understanding of study participation.

Related Conditions & MeSH terms

• Osteosarcoma

Locations

Country	Name	City	State
Spain	Hospital Universitario Cruces	Baracaldo
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Universitario Virgen de la Arrixaca	El Palmar	Murcia
Spain	Hospital Universitario de Canarias	La Laguna
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitario Infantil Niño Jesús	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Universitario Puerta de Hierro	Majadahonda	Madrid
Spain	Hospital Regional Universitario de Málaga	Málaga
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias
Spain	Hospital Universitari Son Espases	Palma De Mallorca
Spain	Complejo Hospitalario Universitario de Santiago	Santiago De Compostela	A Coruña
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Spain	Hospital Universitari i Politècnic La Fe	Valencia
Spain	Hospital Universitario Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Grupo Espanol de Investigacion en Sarcomas

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	Events free survival	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.	After 2 and 3 years from the start of study