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Recruiting NCT05057195

Wide Excision of Soft Tissue Sarcomas in Combination With Interstitial Radiation Therapy

Trial Parameters

Condition Sarcoma
Sponsor Blokhin's Russian Cancer Research Center
Study Type INTERVENTIONAL
Phase N/A
Enrollment 78
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-01-10
Completion 2025-12
Interventions
Interstitial radiation therapyPostoperative external beam therapy

Brief 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 Criteria

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 d

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