Wide Excision of Soft Tissue Sarcomas in Combination With Interstitial Radiation Therapy
NCT05057195
Summary
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
Eligibility
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Conditions3
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NCT05057195