Status:
COMPLETED
ABCB1/P-glycoprotein Expression Influence on Non-metastatic Osteosarcoma of the Extremities
Lead Sponsor:
Grupo Espanol de Investigacion en Sarcomas
Conditions:
Osteosarcoma
Eligibility:
All Genders
12-30 years
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 incl...
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 f...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 2 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 17 2020
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT04383288
Start Date
July 2 2014
End Date
October 17 2020
Last Update
August 4 2021
Active Locations (17)
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1
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, A Coruña, Spain
2
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain
3
Hospital Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain
4
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain, 33011