Multicenter Observational Study on the Treatment of Patients With Localized Osteosarcoma
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Localized Osteosarcoma
- Sponsor
- Italian Sarcoma Group
- Enrollment
- 120
- Locations
- 16
- Primary Endpoint
- 5 years Event Free Survival (EFS)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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.
Investigators
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
Outcomes
Primary Outcomes
5 years Event Free Survival (EFS)
Time Frame: 5 years
Onset of any event (an event is the defined as disease recurrence, death for disease or any other cause)
Secondary Outcomes
- Overall Survival (OS)(at 5 years)
- Adverse events related to the treatments(Every 3 weeks (Week 3, week 6, week 9, week 12, ...) up to 36 months)