Wide Excision of Soft Tissue Sarcomas in Combination With Interstitial Radiation Therapy in Patients With Soft Tissue Sarcomas of the Upper and Lower Extremities Compared With Postoperative Radiation Therapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- disease-free survival
研究概览
简要总结
Intraoperatively, in the bed of the removed tumor, a surgical mesh is sutured onto which the intrastats are fixed. On days 2-3, topometric preparation is carried out, the choice of the amount of irradiation, the calculation of the program. On the 4-5th day after the operation, a course of intra-tissue radiation therapy begins in a single dose of 3 to 5 Gy in 10 fractions 2 times a day with an interval between fractions of 6 hours, the planned total dose is from 30 to 50 Gy. (from 40 to 70 IGy). Follow-up examination after 4 weeks and then every 3 months for 24 months
详细描述
1 day before the operation, taking blood tests: general blood test with counting the leukocyte formula and the number of platelets; biochemical blood test with the determination of indicators of liver and kidney function (including electrolytes); coagulogram; performing surgical treatment with urgent histological examination of the edge of the tumor; intraoperatively, in the bed of the removed tumor, a surgical mesh is sutured onto which the intrastats are fixed with the fixation of the outlet ends on the skin with the help of buttons. 1 day after the operation, taking blood tests: a general blood test with the calculation of the leukocyte formula and the number of platelets; biochemical blood test with the determination of indicators of liver and kidney function (including electrolytes); coagulogram.
On the 2-3rd day after the surgical treatment, topometric preparation, the choice of the amount of radiation, and the calculation of the program are carried out. On the 4-5th day after the operation, a course of interstitial radiation therapy begins in a single dose of 3 to 5 Gy in 10 fractions 2 times a day with an interval between fractions of 6 hours, the planned total dose is from 30 to 50 Gy, which is equivalent to 40 to 70 IGy (isogrey). On the 6th day, removal of intrastats, on the 7th day after the operation, ultrasound of the wound and n / c vessels; assessment of the nature of wound healing. On the 10th day, discharge from the hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •C49.1 Malignant neoplasm of the connective and soft tissues of the upper limb, including the shoulder girdle
- •C49.2 Malignant neoplasm of the connective and soft tissues of the lower limb, including the hip region
- •Tumor size 7 cm or less
- •For malignant tumors: Grade 2-3
- •Locally advanced soft tissue sarcomas
- •Absence of regional metastases
- •Tumor recurrence
排除标准
- •Children, women during pregnancy, childbirth, women during breastfeeding.
- •Military personnel, with the exception of contract military personnel.
- •Persons with mental disorders.
- •Persons detained, taken into custody, serving a sentence in the form of restriction of freedom, arrest, imprisonment or administrative arrest.
- •The age of patients is under 18 years old
- •Histologically confirmed diagnosis of GIST, Kaposi's sarcoma, alveolar, clear cell sarcoma, chondrosarcoma, paraossal osteosarcoma
- •Inoperable tumor
- •A tumor with decay or with the threat of decay
- •The presence of damage to the skin in the affected area
- •The presence of a second malignant tumor
- •Having an active or chronic fungal / bacterial / viral infection
- •Uncontrolled chronic diseases of the liver, kidneys in the acute stage
- •Superficial tumor (within the skin)
- •The use of a reconstructive plastic component using a displaced musculocutaneous flap
- •The use of vascular prosthetics
- •The removed tumor bed is more than 7 cm
- •The presence of a tumor growing into the bone
- •The presence of blood vessels and nerves in the removed tumor bed
- •Presence of metastases
- •Surgical intervention using transplanted skin
结局指标
主要结局
disease-free survival
时间窗: 24 months
Time after treatment during which no sign of cancer is found
次要结局
- Comparison of hospitalization rate(30 days)
- Comparison of safety assessment(24 months)
- Comparison of performance status according Karnofsky scale(24 months)
- Comparison of pain relief according Visual Analogue Scale(24 months)
- Comparison of pain relief according Whatkins scale(24 months)