A Prospective Clinical Study on the Safety and Efficacy of Radiofrequency Ablation for the Treatment of Patients With Desmoid Tumors
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Comparison of safety assessment.
研究概览
简要总结
This is a prospective study on the safety and effectiveness of radiofrequency ablation in patients with desmoid tumors.
In the study group, all patients after radiofrequency ablation of the tumor after 1 month will be evaluated using MRI and CT studies and, if solid components of the tumor are detected, repeated surgical treatment is performed followed by active monitoring after 1 month.
In the absence of a solid component, the effect is estimated by the volume of the necrotic process and monitored in dynamics every 3 months.
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
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with histologically verified diagnosis of dermoid tumor
- •The presence of progressive, symptomatic or functionally significant DF.
- •Written Informed consent to participate in the study
- •Age from 18 to 75 years
- •The functional status of the patient according to the ECOG 0-2 scale
- •Normal renal function (estimated creatinine clearance 60 ml/min);
- •Normal level of bilirubin and liver enzymes (AST, ALT - no more than 3 norms);
- •Left ventricular ejection fraction > 55%
- •Satisfactory bone marrow function (hemoglobin level 9 g/dl, neutrophil count 1.5 thousand/ml, platelet count < 100 thousand/ml);
排除标准
- •The inability to obtain informed consent to participate in the study
- •Synchronous or metachronous cancer
- •Clinically significant diseases of the cardiovascular system
- •Clinically significant CNS diseases
- •Previous grade 2 polyneuropathy and above
- •Current infection or other severe or systemic disease that increases the risk of complications of therapy
- •Pregnancy, lactation
结局指标
主要结局
Comparison of safety assessment.
时间窗: The effectiveness of treatment is monitored 1 month after treatment, then every 3 months for 2 years, every 6 months from 2 to 3 years from the moment of therapy
Adverse Event Assessment and Serious Adverse Event Assessment according to CTCAE 5.0
次要结局
- Overall Response Rate(The effectiveness of treatment is monitored 1 month after treatment, then every 3 months for 2 years, every 6 months from 2 to 3 years from the moment of therapy)
- Duration of responce(3 years)
- Comparison of tumor necrosis based on MRI/CT(The effectiveness of treatment is monitored 1 month after treatment, then every 3 months for 2 years, every 6 months from 2 to 3 years from the moment of therapy)