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

Wide Excision of Soft Tissue Sarcomas in Combination With Interstitial Radiation Therapy in Patients With Soft Tissue Sarcomas of the Upper and Lower Extremities Compared With Postoperative Radiation Therapy

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

Study Overview

• Status: Recruiting
• Conditions: Sarcoma; Soft Tissue Sarcoma
• Intervention / Treatment: Radiation: Interstitial radiation therapy; Radiation: Postoperative external beam therapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 78
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Denis Burov, PhD; Phone Number: +79265585000; Email: denisburov@yandex.ru

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 115478
    • Recruiting
    • Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" оf the Ministry of Health of the Russian Federation
    • Contact: Denis Burov, PhD; Phone Number: +79265585000; Email: denisburov@yandex.ru
    • Sub-Investigator: Denis Burov, PhD
    • Sub-Investigator: Beniamin Bokhyan, PhD
    • Principal Investigator: Aslan Valiev, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interstitial radiation therapy; Duration: 11 days	Radiation: Interstitial radiation therapy; From 30 to 50 Gy,
Active Comparator: Postoperative external beam therapy, on the bed of the removed tumor; Duration: 4 weeks	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
disease-free survival	Time after treatment during which no sign of cancer is found	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of hospitalization rate	Time after surgery till the end of hospitalization	30 days
Comparison of safety assessment	Adverse Event Assessment and Serious Adverse Event Assessment according to CTCAE 5.0	24 months
Comparison of performance status according Karnofsky scale	Improvement on the Karnofsky scale by 10-30 points	24 months
Comparison of pain relief according Visual Analogue Scale	Improvement on the Visual Analogue Scale by 3-5 points	24 months
Comparison of pain relief according Whatkins scale	Improvement on the Whatkins scale by 1-2 points	24 months

Collaborators and Investigators

• Sponsor: Blokhin's Russian Cancer Research Center
• Investigators: Principal Investigator: Aslan Valiev, PhD, N.N. Blokhin NMRCO

Publications and helpful links

Helpful Links

• official site
• russian surcoma group site

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 7, 2021
• First Submitted That Met QC Criteria: September 15, 2021
• First Posted (Actual): September 27, 2021

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Sarcoma; Soft Tissue Sarcoma
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma
• Other Study ID Numbers: SARCBT-2021-7-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No