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

Last updated: March 29, 2024
Sponsor: Blokhin's Russian Cancer Research Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sarcoma

Sarcoma (Pediatric)

Soft Tissue Sarcoma

Treatment

Interstitial radiation therapy

Postoperative external beam therapy

Clinical Study ID

NCT05057195
SARCBT-2021-7-11
  • Ages > 18
  • All Genders

Study 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

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

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 offreedom, arrest, imprisonment or administrative arrest.
  • The age of patients is under 18 years old
  • Histologically confirmed diagnosis of GIST, Kaposi's sarcoma, alveolar, clear cellsarcoma, 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

Study Design

Total Participants: 78
Treatment Group(s): 2
Primary Treatment: Interstitial radiation therapy
Phase:
Study Start date:
January 10, 2022
Estimated Completion Date:
December 31, 2025

Study Description

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.

Connect with a study center

  • Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" оf the Ministry of Health of the Russian Federation

    Moscow, 115478
    Russian Federation

    Active - Recruiting

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