Multicenter Observational Study on the Treatment of Patients With Localized Osteosarcoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 16
- 主要终点
- 5 years Event Free Survival (EFS)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Localized Osteosarcoma
This cohort include patients affected by localized Osteosarcoma, referred to participating Institutions.
干预措施: Treatment of Osteosarcoma according the AIEOP/ISG OS 2021 recommendations (includes drugs, surgery, radiotherapy or any other received treatments) (Other)
结局指标
主要结局
5 years Event Free Survival (EFS)
时间窗: 5 years
Onset of any event (an event is the defined as disease recurrence, death for disease or any other cause)
次要结局
- 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)