Cryotherapy in the Treatment of Desmoid Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- response to treatment
研究概览
简要总结
Desmoid tumor is a benign neoplasm with an unpredictable course and a high rate of local recurrence if treated surgically. Therefore, over time the surgical approach has become conservative, preferring simple observation or medical therapy in case of disease progression through the use of hormonal therapy and low-dose chemotherapy. Since this neoplasm remains benign, our study aims to avoid chemotherapy in patients usually young through the use of a minimally invasive treatment such as cryotherapy.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologic diagnosis of desmoid tumors
- •age > 18 years
- •abdominal and extra-abdominal desmoid tumors
排除标准
- •contraindication to the procedure by the interventional radiologist in terms of tumor proximity to neurologic/vascular structures
- •retroperitoneal desmoid tumors
- •age < 18 years
结局指标
主要结局
response to treatment
时间窗: At baseline (time 0)
assessment of tumor response to treatment will be performed using the solid tumor response criteria
次要结局
未报告次要终点
研究者
Costantino Errani
Principal Investigator
Istituto Ortopedico Rizzoli
