Combined Treatment of Patients With Soft Tissue Sarcoma Including Preoperative Stereotactic Radiation Therapy and Postoperative Conformal Radiation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Complications
研究概览
简要总结
Combined treatment of soft tissue sarcoma includes 3 steps:
- step - preoperative stereotactic radiation therapy in hypofractionation mode
- step - operation
- step - postoperative conformal radiation therapy in normofractionation mode
详细描述
Combined treatment of soft tissue sarcoma includes 3 steps:
- At the first step patient undergoes preoperative stereotactic radiation therapy in hypofractionation mode. Radiation therapy plan is based on topometric MRI and CT scans. Radiation therapy plan are performed after MRI and CT fusion, contouring of the target and surrounding normal tissues.
At first step only tumor and, if necessary, the surrounding normal tissues, which will be removed during surgery, are exposed to radiation.
GTV - determined in with the boundaries of the tumor visualised by topometric MRI and CT CTV1 - match GTV CTV2 - formed inward (to the tumor center) from GTV by 0.5-1 cm (depending on the proximity of functionally significant normal tissues (neurovascular bundles, bone tissue, skin and subcutaneous fat, etc.) PTV - 3-5 mm indent from CTV1, taking into account the proximity of functionally significant normal tissues and the planned surgery Preoperative radiation therapy is carried in 5 fractions with a single dose on PTV - 5 Gy, a single dose on CTV2 - 7 Gy. 2. Second step is surgery in 14-21 days. 3. In 25-35 days after the surgery postoperative conformal radiation therapy is performed according to the standard protocol GTV (tumor bed) - based on the volume of the primary tumor, including the swelling zone (T2-weighted images on preoperative MRI) СTV - formed with an indent of 4 cm from GTV (without going beyond the boundaries of the involved compartment), in the transverse direction the indent could be reduced to 2 cm.
PTV - formed with an indent of 0.5-1cm from CTV An important condition for planning radiation therapy is to limit the dose absorbed during both stages of radiation therapy in surrounding normal tissues that are not removed during surgery.
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
- 否
入选标准
- •morphologically verified diagnosis of soft tissue sarcoma
- •first diagnosed tumor process
- •ability to perform radical surgery
- •signed informed consent
- •indications for stereotactic and conformal radiation therapy
- •no contraindications for radiation and surgical treatment
排除标准
- •previous radiation treatment
- •acute infection
- •pregnancy, lactation
- •recurrent tumor
- •refuse to sign informed consent
- •conditions that can affect the outcome of treatment (immunodeficiency, tuberculosis, etc.)
- •tumor topography and volume that don't allow to perform stereotactic and conformal radiation therapy.
结局指标
主要结局
Complications
时间窗: 3 year
Rate of complications will be measured after completing each step of protocol: stereotactic radiation therapy, surgery and them postoperative conformal radiation therapy
次要结局
- Disease-Free survival(3 year)
