Trials / Recruiting
RecruitingNCT04890067
Observational Study in Localized Osteosarcoma
Multicenter Observational Study on the Treatment of Patients With Localized Osteosarcoma
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 120 (estimated)
- Sponsor
- Italian Sarcoma Group · Network
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2021-07-30
- Primary completion
- 2026-06-30
- Completion
- 2026-12-30
- First posted
- 2021-05-18
- Last updated
- 2026-03-27
Locations
16 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT04890067. Inclusion in this directory is not an endorsement.