Wide Excision of Soft Tissue Sarcomas in Combination With Interstitial Radiation Therapy (NCT05057195) | Clinical Trial Compass
UnknownNot Applicable
Wide Excision of Soft Tissue Sarcomas in Combination With Interstitial Radiation Therapy
Russia78 participantsStarted 2022-01-10
Plain-language 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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 v…