Observational Study in Localized Osteosarcoma

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Multicenter Observational Study on the Treatment of Patients With Localized Osteosarcoma

Conditions
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Localized Osteosarcoma

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Localized Osteosarcoma<br>This cohort include patients affected by localized Osteosarcoma, referred to participating Institutions. | Other: Treatment of Osteosarcoma according the AIEOP/ISG OS 2021 recommendations (includes drugs, surgery, radiotherapy or any other received treatments)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | Time elapsed for the diagnosis to the death for any cause | 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 | Every 3 weeks (Week 3, week 6, week 9, week 12, ...) up to 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteosarcoma