Observational Study in Localized Osteosarcoma

Recruiting

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

• Registration Number: NCT04890067
• Lead Sponsor: Italian Sarcoma Group

Brief 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

Detailed 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 Timeline

• Study First Submitted: 2021-05-12
• Study First Submitted QC: 2021-05-12
• Study First Posted: 2021-05-18
• Study Start: 2021-07-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-10
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Localized Osteosarcoma	Treatment of Osteosarcoma according the AIEOP/ISG OS 2021 recommendations (includes drugs, surgery, radiotherapy or any other received treatments)	This cohort include patients affected by localized Osteosarcoma, referred to participating Institutions.

Primary Outcome Measures

Name	Time	Method
5 years Event Free Survival (EFS)	5 years	Onset of any event (an event is the defined as disease recurrence, death for disease or any other cause)

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	at 5 years	Time elapsed for the diagnosis to the death for any cause
Adverse events related to the treatments	Every 3 weeks (Week 3, week 6, week 9, week 12, ...) up to 36 months	Number of Participants with Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events version 5.0

Trial Locations

Locations (16)

Centro di Riferimento Oncologico - Unit of Medical Oncology; 🇮🇹 Aviano, Pordenone, Italy

Sandra Aliberti; 🇮🇹 Candiolo, Torino, Italy

IRCCS materno infantile Burlo Garofolo; 🇮🇹 Trieste, T, Italy

Azienda Ospedaliero Universitaria Consorziale Policlinico - Bari; 🇮🇹 Bari, Italy

IRCCS Istituto ortopedico Rizzoli; 🇮🇹 Bologna, Italy

A.O. Universitaria Policlinico S. Orsola Malpighi di Bologna; 🇮🇹 Bologna, Italy

AUO Policnico G. Rodolico San Marco; 🇮🇹 Catania, Italy

A.O. Universitaria Meyer; 🇮🇹 Firenze, Italy

Istituto Giannina Gaslini; 🇮🇹 Genova, Italy

Fondazione IRCCS INT Milano SC Pediatria Oncologica; 🇮🇹 Milano, Italy

FONDAZIONE IRCCS Istituto Nazionale dei Tumori; 🇮🇹 Milano, Italy

Azienda Ospedaliera di Padova UOC Oncoematologia Pediatrica; 🇮🇹 Padova, Italy

ARNAS P. O. "Civico e Benfratelli"; 🇮🇹 Palermo, Italy

Azienda Ospedaliero-Universitaria Pisana; 🇮🇹 Pisa, Italy

Istituti Fisioterapici Ospitalieri di Roma; 🇮🇹 Roma, Italy

Ospedale Pediatrico Bambin Gesu'; 🇮🇹 Roma, Italy