Observational Study in Localized Osteosarcoma

Italian Sarcoma Group120 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

120

Conditions

Localized Osteosarcoma

Interventions

Treatment of Osteosarcoma according the AIEOP/ISG OS 2021 recommendations (includes drugs, surgery, radiotherapy or any other received treatments)OTHER

This observational study collects all the treatments received by the patients according according the AIEOP/ISG OS 2021 and therefore includes drug/biological/surgical/ radiotherapy and any other applicable treatments

Eligibility

Sex: ALLMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of high grade OS of the extremities * Age at diagnosis ≤ 40 years at the time of diagnosis * Localized disease (skip metastases are allowed) * Adequate organ function according the AIEOP/ISG OS 2021 recommendation * Patients or parents oe guardians of minors who have given their written informed consent to participate in the study Exclusion Criteria: * Presence of metastases * Diagnosis of periosteal OS, of parosteal OS or secondary OS * Any medical condition which can not allowed the use of the treatments recommended by AIEOP/ISG OS 2021

Locations (16)

Centro di Riferimento Oncologico - Unit of Medical Oncology

Aviano, Pordenone, Italy

RECRUITING

Sandra Aliberti

Candiolo, Torino, Italy

Outcomes

Primary Outcomes

5 years Event Free Survival (EFS)

Onset of any event (an event is the defined as disease recurrence, death for disease or any other cause)

Time frame: 5 years

Secondary Outcomes

Overall Survival (OS)

Time elapsed for the diagnosis to the death for any cause

Time frame: at 5 years

Adverse events related to the treatments

Number of Participants with Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events version 5.0

Time frame: Every 3 weeks (Week 3, week 6, week 9, week 12, ...) up to 36 months

Central Contacts

Franca Fagioli, MD/Prof

CONTACT

0039-0113135 franca.fagioli@unito.it

Sebastian D Asaftei, MD

CONTACT

0039-011 3135 sebastiandorin.asaftei@unito.it

Data from ClinicalTrials.gov

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