Observational study of localized osteosarcoma characteristics and treatments

Multicenter Observational Study on the Treatment of Patients With Localized Osteosarcoma

This study is looking at the characteristics and treatments of people with localized osteosarcoma to see how well current therapies work and to help improve future care.

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Ages: N/A to 40 Years
• Sex: All
• Sponsor: Italian Sarcoma Group (Research network)
• Drugs / interventions: chemotherapy, methotrexate
• Locations: 16 sites (Aviano, Pordenone and 15 other locations)
• Trial ID: NCT04890067 on ClinicalTrials.gov

What this trial studies

This observational study aims to collect demographic, clinical, surgical, pathological, and molecular data from patients diagnosed with localized osteosarcoma. It focuses on individuals treated according to the AIEOP/Italian Sarcoma Group OS 2021 guidelines, which include a combination of chemotherapy and surgical intervention. The study will gather information on treatment outcomes and characteristics to enhance understanding of this rare disease. By documenting these factors, the study seeks to improve future treatment protocols for localized osteosarcoma.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 40 years or younger diagnosed with high-grade localized osteosarcoma.

Not a fit: Patients with metastatic osteosarcoma or those with specific types of osteosarcoma such as periosteal or parosteal may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies and outcomes for patients with localized osteosarcoma.

How similar studies have performed: While there have been studies on osteosarcoma treatment, this observational approach focusing on localized cases and comprehensive data collection is relatively novel.

Eligibility criteria

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

Where this trial is running

Aviano, Pordenone and 15 other locations

• Centro di Riferimento Oncologico - Unit of Medical Oncology — Aviano, Pordenone, Italy (Recruiting)
• Sandra Aliberti — Candiolo, Torino, Italy (Recruiting)
• IRCCS materno infantile Burlo Garofolo — Trieste, T, Italy (Recruiting)
• Azienda Ospedaliero Universitaria Consorziale Policlinico - Bari — Bari, Italy (Recruiting)
• IRCCS Istituto ortopedico Rizzoli — Bologna, Italy (Recruiting)
• A.O. Universitaria Policlinico S. Orsola Malpighi di Bologna — Bologna, Italy (Recruiting)
• AUO Policnico G. Rodolico San Marco — Catania, Italy (Recruiting)
• A.O. Universitaria Meyer — Florence, Italy (Recruiting)
• Istituto Giannina Gaslini — Genova, Italy (Recruiting)
• Fondazione IRCCS INT Milano SC Pediatria Oncologica — Milan, Italy (Recruiting)
• FONDAZIONE IRCCS Istituto Nazionale dei Tumori — Milan, Italy (Recruiting)
• Azienda Ospedaliera di Padova UOC Oncoematologia Pediatrica — Padova, Italy (Recruiting)
• ARNAS P. O. "Civico e Benfratelli" — Palermo, Italy (Recruiting)
• Azienda Ospedaliero-Universitaria Pisana — Pisa, Italy (Recruiting)
• Istituti Fisioterapici Ospitalieri di Roma — Roma, Italy (Recruiting)
• Ospedale Pediatrico Bambin Gesu' — Roma, Italy (Not_yet_recruiting)

Study contacts

• Study coordinator: Franca Fagioli, MD/Prof

Conditions Localized Osteosarcoma; Osteosarcoma