Localized Osteosarcoma
Conditions
Keywords
Osteosarcoma
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.
Interventions
OTHERTreatment 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
Sponsors
Italian Sarcoma Group
Associazione Italiana Ematologia Oncologia Pediatrica
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 5 years Event Free Survival (EFS) | 5 years | Onset of any event (an event is the defined as disease recurrence, death for disease or any other cause) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | at 5 years | Time elapsed for the diagnosis to the death for any cause |
| Adverse events related to the treatments | Every 3 weeks (Week 3, week 6, week 9, week 12, ...) up to 36 months | Number of Participants with Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events version 5.0 |
Countries
Italy
Contacts
CONTACTFranca Fagioli, MD/Prof
CONTACTSebastian D Asaftei, MD
Outcome results
None listed