Presurgical Chemotherapy Compared With Immediate Surgery and Adjuvant Chemotherapy for Nonmetastatic Osteosarcoma of the Pelvis and Sacrum

Peking University People's Hospital1 个研究点分布在 1 个国家目标入组 100 人开始时间: 2018年8月1日最近更新: 2018年8月28日

适应症

干预措施

试验速览

阶段: 不适用
状态: 招募中
发起方: Peking University People's Hospital
入组人数: 100
试验地点: 1
主要终点: Overall survival (OS)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To study the effect of the timing of surgery on outcome of patients with nonmetastatic osteosarcoma of pelvis and sacrum.

详细描述

Successful therapeutic interventions to prevent disease progression in patients with nonmetastatic osteosarcoma of pelvis and sacrum have included surgery with adjuvant chemotherapy. Pre-surgical chemotherapy has been advocated for these patients because of putative improvement in event-free survival (EFS). The advantages of pre-surgical chemotherapy include early administration of systemic chemotherapy, shrinkage of primary tumor, and pathologic identification of risk groups. The theoretic disadvantage is that it exposes a large tumor burden to marginally effective chemotherapy, especially in the axial region. The contribution of chemotherapy and surgery timing has not been tested rigorously. To study the effect of the timing of surgery on outcome of patients with nonmetastatic osteosarcoma of pelvis and sacrum, we conducted multicenter randomized trial to determine whether chemotherapy administered before definitive resection of primary tumors improved EFS and overall survival compared with traditional resection of the primary tumor followed by adjuvant chemotherapy.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 10 Years 至 40 Years（Child, Adult）
性别: All
接受健康志愿者: 否

入选标准

•Age >10 years and <40 years;
•High-grade nonmetastatic osteosarcoma in pelvis or sacrum;
•Diagnosis confirmed histologically and reviewed centrally;
•No evidence of metastatic disease with computed tomography scan of the chest and radionuclide bone scan, or Positron Emission Tomography (PET/CT) within 2 weeks of entry;
•No prior therapy;
•Eastern Cooperative Oncology Group performance status 0-1;
•Life expectancy >3 months;
•Adequate renal, hepatic, and hemopoietic function;

排除标准

•Previously treated by chemotherapy or unplanned surgery in other hospital;
•Have had other kinds of malignant tumors at the same time;
•Uncontrolled complications, such as diabetes mellitus and so on;
•Intravascular tumor thrombus on enhanced CT or magnetic resonance (MR);
•Unresectable disease evaluated by surgeons.

研究组 & 干预措施

Pre surgical Chemotherapy

Experimental

Immediate pre surgical chemotherapy treated with four drugs including doxorubicin, cisplatin, high-dose methotrexate (MTX) and ifosfamide in eleven weeks, and then definitive surgery followed by adjuvant chemotherapy according to chemotherapy regimen in Peking University People's Hospital(PKUPH).

干预措施: Doxorubicin (Drug)

Pre surgical Chemotherapy

Experimental

干预措施: Cisplatin (Drug)

Pre surgical Chemotherapy

Experimental

干预措施: Methotrexate (Drug)

Pre surgical Chemotherapy

Experimental

干预措施: Ifosfamide (Drug)

Pre surgical Chemotherapy

Experimental

干预措施: definitive surgery (Procedure)

Pre surgical Chemotherapy

Experimental

干预措施: pre surgical chemotherapy (Other)