NCT00586846已完成2 期
Phase II Study of Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Radiographic Response
研究概览
简要总结
This study is designed to test the safety and feasibility of the simultaneous administration of a biphosphonate with chemotherapy for the treatment of osteosarcoma in newly diagnosed patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed, previously untreated biopsy proven high-grade osteosarcoma. Patient who have undergone a definitive surgical resection as their primary surgery are still eligible for participation in this study.
- •No prior chemotherapy or radiation therapy
- •Adequate renal function: creatinine < or = to 1.5 upper limit of normal
- •Adequate liver function as defined by bilirubin < or = to 1.5 X upper limit of normal and AST < or = to 3 X upper limit of normal institutional range Adequate hematopoietic function as defined by platelet count > or = to 100,000/ram3 an absolute neutrophil count > or = to 1,000/mm
- •Adequate cardiac function as defined by shortening fraction > or = to 28% by echocardiogram OR ejection fraction > or = to 50% by radionuclide angiogram
- •Performance status < or = to 2
排除标准
- •Prior history of cancer
- •Prior treatment for cancer
- •Prior history of Paget's disease
- •Prior history of pericarditis, myocarditis, symptomatic arrhythmia or symptomatic cardiac conduction abnormalities
- •Pregnancy or breast feeding
研究组 & 干预措施
1
Experimental
干预措施: Cisplatin (Drug)
1
Experimental
干预措施: Doxorubicin (Drug)
1
Experimental
干预措施: Methotrexate (Drug)
结局指标
主要结局
Radiographic Response
时间窗: 2 years
to the induction chemotherapy in the primary tumor and in any metastatic lesions using the Response Evaluation Criteria (RECIST).
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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