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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-10

Study Completion Date

2025-12-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Sarcoma Soft Tissue Sarcoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Interstitial radiation therapy

Duration: 11 days

Group Type EXPERIMENTAL

Interstitial radiation therapy

Intervention Type RADIATION

From 30 to 50 Gy,

Postoperative external beam therapy, on the bed of the removed tumor

Duration: 4 weeks

Group Type ACTIVE_COMPARATOR

Postoperative external beam therapy

Intervention Type RADIATION

50 Gy and locally on the tumor bed up to 10-26 Gy, depending on the status of the resection margin

Interventions

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Interstitial radiation therapy

From 30 to 50 Gy,

Intervention Type RADIATION

Postoperative external beam therapy

50 Gy and locally on the tumor bed up to 10-26 Gy, depending on the status of the resection margin

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No