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Clinical Trial Summary

Observational prospective trial aimed to collect the collect demographic, clinical, surgical, pathological and molecular characteristics and treatment from patients affected by localized OsteoSarcoma (OS) treated according the AIEOP/Italian Sarcoma Group (ISG) OS 2021


Clinical Trial Description

Osteosarcoma is the most frequent primary malignant bone tumor in children and adolescents and is considered a rare disease. The overall incidence of OS is 0.2-3 / 100,000 inhabitants per year with a bimodal distribution by age, with a first peak in adolescence. Currently, the treatment strategy for localized OS includes courses of neo-adjuvant chemotherapy based on 3 agents: Adriamycin (ADM), cisplatin (CDP) and high dose methotrexate (HDMTX) followed by surgical removal of the primary tumor and subsequent adjuvant chemotherapy treatment. The MAP (Methotrexate, Adriamycin, cisPlatin) regimen, with or without ifosfamide (IFO) and etoposide (ETO), is considered the "gold standard" for the treatment of localized osteosarcoma. Given the rarity of the disease, it is considered appropriate to collect information prospectively on the diagnosis, chemotherapy and surgical treatment and outcomes on patients treated by the network of AIEOP and ISG Centers according to the recommendations on the treatment of localized OS AIEOP/ISG OS 2021. This study will be active up to the next interventional prospective protocol aimed at the therapy of high-grade, non-metastatic OS. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04890067
Study type Observational
Source Italian Sarcoma Group
Contact Franca Fagioli, MD/Prof
Phone 0039-0113135
Email franca.fagioli@unito.it
Status Recruiting
Phase
Start date July 30, 2021
Completion date December 30, 2026

See also
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Completed NCT00954473 - Study of Blood Samples From Patients With Osteosarcoma N/A
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Completed NCT01190943 - DNA Biomarkers in Tissue Samples From Patients With Osteosarcoma