ABCB1/P-glycoprotein Expression as Biologic Stratification Factor for Patients With Non Metastatic Osteosarcoma - Prospective Study (ISG/OS-2)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 225
- 试验地点
- 11
- 主要终点
- Events free survival
研究概览
简要总结
This is a phase II multicentre, uncontrolled trial including patients ≤ 40 years with non-metastatic extremity high-grade osteosarcoma stratified according to P-glicoprotein expression
详细描述
The main objective of the study is to evaluate the impact on event-free survival (EFS) of a multi-drug chemotherapy approach and mifamurtide treatment in patients with non-metastatic osteosarcoma of the extremities according to the expression of ABCB1/P-glycoprotein
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Histology confirmed diagnosis of extremities high grade osteosarcoma
- •Age ≤ 40 years
- •Localized disease or presence of skip metastasis
- •Hepatic, renal and bone marrow normal function
- •LVEF > 50%
- •No previous surgery and/ or chemotheraputic osteosarcoma treatments,
- •No more than 4 weeks interval between histological diagnosis and start of chemotherapy
- •Informed consent to the study participation obtained.
排除标准
- •Presence of metastases other than skip metastases
- •Periosteal Osteosarcoma, parostal osteosarcoma, secondary osteosarcoma,
- •Medical contra-indication to the drugs foreseen in the protocol,
- •Subject is pregnant or breast feeding
- •Mental or social conditions that can compromise a correct adherence to the protocol and its procedures
研究组 & 干预措施
Mifamurtide arm
Chemotherapy for patients who over express ABCB1/P-glycoprotein (methotrexate, cisplatinum, doxorubicine, ifosfamide + mifamurtide)
干预措施: Mifamurtide arm (Drug)
3 drugs arm
High grade osteosarcoma treatment for patients who do not over express ABCB1/P-glycoprotein
干预措施: 3 drugs arm (Other)
结局指标
主要结局
Events free survival
时间窗: After 5 years from the time to first day of chemotherapy for all patients and from the date of surgery for the Pgp overexpression patients stratified according to tumor necrosis (Good Responders and Poor Responders).
Onset of any event. An event is the defined as disease recurrence (local or distant), death for disease or any other cause, onset of secondary tumors or the last follow-up examination
次要结局
- Overall Survival(After 5 years from the time to first day of chemotherapy for all patients and from the date of surgery for the Pgp overexpression patients stratified according to tumor necrosis (Good Responders and Poor Responders).)