Actively Recruiting

Age: 0 - 40Years
All Genders
ID04890067

Multicenter Observational Study on the Treatment of Patients With Localized Osteosarcoma

Led by Italian Sarcoma Group · Updated on 2026-03-27

120

Participants Needed

16

Research Sites

26 weeks

Total Duration

On this page

Sponsors

I

Italian Sarcoma Group

Lead Sponsor

A

Associazione Italiana Ematologia Oncologia Pediatrica

Collaborating Sponsor

AI-Summary

What this Trial Is About

Osteosarcoma is a rare type of primary bone cancer most commonly seen in children and adolescents. This observational prospective trial focuses on patients with localized Osteosarcoma treated according to the AIEOP/Italian Sarcoma Group (ISG) OS 2021 protocol. The study aims to collect detailed demographic, clinical, surgical, pathological, molecular, and treatment information to better understand outcomes for patients receiving recommended therapies. The treatments collected include chemotherapy, surgery, radiotherapy, and any other therapies given according to the AIEOP/ISG OS 2021 recommendations. The standard treatment involves neoadjuvant chemotherapy with drugs such as Adriamycin, cisplatin, and high-dose methotrexate, followed by surgery to remove the tumor and additional chemotherapy afterward. Patients included in this study have localized disease and are treated at participating centers within the study network. Participants will be followed to record treatment details, adverse events every 3 weeks up to 36 months, and outcomes including 5-year event-free survival and overall survival. The study will gather data prospectively until a new interventional protocol is introduced. This long-term monitoring will provide important insights into treatment effects and patient outcomes over at least five years.

CONDITIONS

Brief Title

Observational Study in Localized Osteosarcoma

Who Can Participate

Age: 0 - 40Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of high-grade Osteosarcoma of the extremities
  • Age 40 years or younger at diagnosis
  • Localized disease (skip metastases allowed)
  • Adequate organ function as per AIEOP/ISG OS 2021 recommendations
  • Written informed consent given by patient or guardian for minors
Not Eligible

You will not qualify if you...

  • Presence of metastases
  • Diagnosis of periosteal, parosteal, or secondary Osteosarcoma
  • Any medical condition preventing use of treatments recommended by AIEOP/ISG OS 2021

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 5 years

Participants who undergo routine care for localized osteosarcoma are observed. Information on diagnosis, chemotherapy, surgical treatment, and outcomes is collected according to the AIEOP/ISG OS 2021 recommendations.

Visits approximately every 3 weeks up to 36 months, with long-term follow-up for survival outcomes up to 5 years

Trial Site Locations

Total: 16 locations

1

Centro di Riferimento Oncologico - Unit of Medical Oncology

Aviano, Pordenone, Italy, 33081

Actively Recruiting

2

Sandra Aliberti

Candiolo, Torino, Italy, 10060

Actively Recruiting

3

IRCCS materno infantile Burlo Garofolo

Trieste, T, Italy, 34137

Actively Recruiting

4

Azienda Ospedaliero Universitaria Consorziale Policlinico - Bari

Bari, Italy, 70124

Actively Recruiting

5

IRCCS Istituto ortopedico Rizzoli

Bologna, Italy, 40136

Actively Recruiting

6

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

Bologna, Italy, 40138

Actively Recruiting

7

AUO Policnico G. Rodolico San Marco

Catania, Italy, 95123

Actively Recruiting

8

A.O. Universitaria Meyer

Florence, Italy, 50139

Actively Recruiting

9

Istituto Giannina Gaslini

Genova, Italy

Actively Recruiting

10

Fondazione IRCCS INT Milano SC Pediatria Oncologica

Milan, Italy

Actively Recruiting

11

FONDAZIONE IRCCS Istituto Nazionale dei Tumori

Milan, Italy

Actively Recruiting

12

Azienda Ospedaliera di Padova UOC Oncoematologia Pediatrica

Padova, Italy

Actively Recruiting

13

ARNAS P. O. "Civico e Benfratelli"

Palermo, Italy, 90127

Actively Recruiting

14

Azienda Ospedaliero-Universitaria Pisana

Pisa, Italy, 56126

Actively Recruiting

15

Istituti Fisioterapici Ospitalieri di Roma

Roma, Italy

Actively Recruiting

16

Ospedale Pediatrico Bambin Gesu'

Roma, Italy

Not Yet Recruiting

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Research Team

F

Franca Fagioli, MD/Prof

S

Sebastian D Asaftei, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Osteosarcoma incidence and survival rates from 1973 to 2004: data from the Surveillance, Epidemiology, and End Results Program.

Lisa Mirabello, Rebecca J Troisi, Sharon A Savage

https://pubmed.ncbi.nlm.nih.gov/19197972

Prognostic factors in high-grade osteosarcoma of the extremities or trunk: an analysis of 1,702 patients treated on neoadjuvant cooperative osteosarcoma study group protocols.

Stefan S Bielack, Beate Kempf-Bielack, Günter Delling...

https://pubmed.ncbi.nlm.nih.gov/11821461

Neoadjuvant chemotherapy with methotrexate, cisplatin, and doxorubicin with or without ifosfamide in nonmetastatic osteosarcoma of the extremity: an Italian sarcoma group trial ISG/OS-1.

Stefano Ferrari, Pietro Ruggieri, Graziella Cefalo...

https://pubmed.ncbi.nlm.nih.gov/22564997