Clinical Evaluation for Sarcoma Originated From Bone
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Pathological response rate
研究概览
简要总结
Response Evaluation Criteria in Solid Tumors (RECIST) are insensitive in evaluating primary sarcoma originated from bone treated with chemotherapy or targeted therapy, which did not have the definition of measurement methods either. This study evaluates whether clinical imaging findings of sarcoma after preoperative chemotherapy correlate with tumor responses by pathological evaluation by Huvos classifications and develops reliable, quantitative, clinical response criteria.
详细描述
A total of 1570 lesions were evaluated by clinical imaging including X-ray, computed tomography, magnetic resonance imaging and bone scan or PET/CT preoperatively treated with chemotherapy. All patients had surgery in our center and get pathological evaluation by tumor necrosis rate. Statistical diversity analysis was performed by different pathological groups and Receiver Operating Characteristic Curves，ROC were done to find the dividing clinical parameters (Cut-off values) to distinguish different pathological groups.The cut-off values of change rate of maximum diameters of tumor located in extremities were 86%, 50.7% and 0.02% for Huvos Ⅳ,Ⅲ,ⅡandⅠgroups. The differentiation was not obvious using bone scan to distinguish different pathological responses. And the cut-off value for SUVmax value for Huvos Ⅲ,ⅡandⅠgroups were 60.7% and 31.4%.After Multidisciplinary discussion in multiple sites of China, we finally designed a evaluation system based on our data. This study is desgined to prospectively compare the sensitivity and specificity of this Clinical evaluation of primary sarcoma originated from bone with other clinical evaluation system,such as RECIST 1.1, Choi and PERCIST.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed high-grade osteosarcoma;
- •initially treated in Musculoskeletal Tumor Center of Peking University People's Hospital, Xijing Hospital or The Second Hospital affiliated to Zhejiang Hospital;
- •imaging evaluation should be available;
- •completed neo-adjuvant chemotherapy and at least 8 cycles of adjuvant chemotherapy;
- •expected to live longer than 3 months with Eastern Cooperative Oncology Group performance status of 0 or 1;
- •acceptable hematologic, hepatic, and renal function.
排除标准
- •Patients who could not complete neo-adjuvant chemotherapy or at least 4-month adjuvant chemotherapy;
- •lost to follow-up.
结局指标
主要结局
Pathological response rate
时间窗: 12 months
tumor necrosis rate descripted by Huvos
Specificity
时间窗: 12 months
Specificity is defined as the true wrong clincial evuluated number /the pathological evaluated number by different classification system.
Sensitivity
时间窗: 12 months
Sensitivity is defined as the true right clinical evaluated number/ the pathological evaluated number by different classification system.
次要结局
- overall survival(60 months)
- progression-free survival(24 months)