OS2006 : Protocole de Traitement Des ostéosarcomes de l'Enfant, de l'Adolescent et de l'Adulte Comportant
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- UNICANCER
- 入组人数
- 318
- 试验地点
- 37
- 主要终点
- Event-free survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Zoledronic acid may stop the growth of tumor cells in bone. Giving chemotherapy with or without zoledronic acid before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving combination chemotherapy together with zoledronic acid is more effective than combination chemotherapy alone in treating osteosarcoma.
PURPOSE: This randomized phase III trial is studying combination chemotherapy and zoledronic acid to see how well they work compared with combination chemotherapy alone in treating patients with osteosarcoma.
详细描述
OBJECTIVES:
Primary
- Compare the progression-free survival of patients with osteosarcoma treated with combination chemotherapy with or without zoledronic acid.
Secondary
- Compare the overall survival of patients treated with these regimens.
- Compare the percentage of patients with a good histologic response.
- Compare the long and short term toxicity of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Chemotherapy + zoledronic acid
干预措施: ifosfamide (Drug)
Chemotherapy + zoledronic acid
干预措施: cisplatin (Drug)
Chemotherapy + zoledronic acid
干预措施: doxorubicin hydrochloride (Drug)
Chemotherapy + zoledronic acid
干预措施: etoposide (Drug)
Chemotherapy + zoledronic acid
干预措施: methotrexate (Drug)
Chemotherapy + zoledronic acid
干预措施: zoledronic acid (Drug)
Chemotherapy + zoledronic acid
干预措施: conventional surgery (Procedure)
chemotherapy
干预措施: cisplatin (Drug)
chemotherapy
干预措施: doxorubicin hydrochloride (Drug)
chemotherapy
干预措施: etoposide (Drug)
chemotherapy
干预措施: ifosfamide (Drug)
chemotherapy
干预措施: methotrexate (Drug)
chemotherapy
干预措施: conventional surgery (Procedure)
结局指标
主要结局
Event-free survival
时间窗: 3 years
次要结局
- Overall survival(10 years)
- Percentage of good responders(at the time of the surgery)
- Short term and long term toxicity(10 years)