An observational study in Localized Osteosarcoma, sponsored by Italian Sarcoma Group. Recruiting at 16 sites in Italy. Open to participants aged Up to 40 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Italian Sarcoma Group · Observational
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
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.
488 studies on the registry are indexed under Osteosarcoma; 124 are open to participants now.
This study's planned enrollment of 120 is above the median of 100 across 99 observational studies indexed under Osteosarcoma.
Browse Osteosarcoma studies →Italian Sarcoma Group is the lead sponsor of 31 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with localized high grade ostesarcoma of the extremities
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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
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)
Time frame: 5 years
Overall Survival (OS)
Time elapsed for the diagnosis to the death for any cause
Time frame: 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
Time frame: Every 3 weeks (Week 3, week 6, week 9, week 12, ...) up to 36 months
Plan to share: No — No plan sharing
Started Jul 2021 (actual). Primary completion is estimated for Sep 2029, 98 months after the start.
Of 41 observational studies under Osteosarcoma, half reached primary completion within 76 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 228. This study's planned 98 months is above that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 3, 2026: primary completion Sep 2026 → Sep 2029 and completion Dec 2026 → Dec 2029.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Italian Sarcoma Group