Observational Study in Localized Osteosarcoma

Last updated: March 7, 2025
Sponsor: Italian Sarcoma Group
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteosarcoma

Treatment

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

Clinical Study ID

NCT04890067
AIEOP/ISGOS2 Oss
  • Ages < 40
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 informedconsent to participate in the study

Exclusion

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 byAIEOP/ISG OS 2021

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: Treatment of Osteosarcoma according the AIEOP/ISG OS 2021 recommendations (includes drugs, surgery, radiotherapy or any other received treatments)
Phase:
Study Start date:
July 30, 2021
Estimated Completion Date:
December 30, 2026

Study 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.

Connect with a study center

  • Centro di Riferimento Oncologico - Unit of Medical Oncology

    Aviano, Pordenone 33081
    Italy

    Active - Recruiting

  • IRCCS materno infantile Burlo Garofolo

    Trieste, T 34137
    Italy

    Active - Recruiting

  • Fondazione del Piemonte per l'Oncologia IRCC Candiolo

    Candiolo, Torino 10060
    Italy

    Site Not Available

  • Sandra Aliberti

    Candiolo, Torino 10060
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Consorziale Policlinico - Bari

    Bari, 70124
    Italy

    Active - Recruiting

  • A.O. Universitaria Policlinico S. Orsola Malpighi di Bologna

    Bologna, 40138
    Italy

    Active - Recruiting

  • IRCCS Istituto ortopedico Rizzoli

    Bologna, 40136
    Italy

    Active - Recruiting

  • AUO Policnico G. Rodolico San Marco

    Catania, 95123
    Italy

    Active - Recruiting

  • A.O. Universitaria Meyer

    Firenze, 50139
    Italy

    Active - Recruiting

  • Istituto Giannina Gaslini

    Genova,
    Italy

    Active - Recruiting

  • FONDAZIONE IRCCS Istituto Nazionale dei Tumori

    Milano,
    Italy

    Active - Recruiting

  • Fondazione IRCCS INT Milano SC Pediatria Oncologica

    Milano,
    Italy

    Active - Recruiting

  • Azienda Ospedaliera di Padova UOC Oncoematologia Pediatrica

    Padova,
    Italy

    Active - Recruiting

  • ARNAS P. O. "Civico e Benfratelli"

    Palermo, 90127
    Italy

    Active - Recruiting

  • Azienda Ospedaliero-Universitaria Pisana

    Pisa, 56126
    Italy

    Active - Recruiting

  • Istituti Fisioterapici Ospitalieri di Roma

    Roma,
    Italy

    Active - Recruiting

  • Ospedale Pediatrico Bambin Gesu'

    Roma,
    Italy

    Site Not Available

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