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

Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05057195
• Other study ID #: SARCBT-2021-7-11
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2022
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Blokhin's Russian Cancer Research Center
• Contact: Denis Burov, PhD
• Phone: +79265585000
• Email: denisburov[@]yandex.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Sarcoma

Intervention

Radiation:
• Interstitial radiation therapy
From 30 to 50 Gy,
• 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

Locations

Country	Name	City	State
Russian Federation	Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" ?f the Ministry of Health of the Russian Federation	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Blokhin's Russian Cancer Research Center

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease-free survival	Time after treatment during which no sign of cancer is found	24 months
Secondary	Comparison of hospitalization rate	Time after surgery till the end of hospitalization	30 days
Secondary	Comparison of safety assessment	Adverse Event Assessment and Serious Adverse Event Assessment according to CTCAE 5.0	24 months
Secondary	Comparison of performance status according Karnofsky scale	Improvement on the Karnofsky scale by 10-30 points	24 months
Secondary	Comparison of pain relief according Visual Analogue Scale	Improvement on the Visual Analogue Scale by 3-5 points	24 months
Secondary	Comparison of pain relief according Whatkins scale	Improvement on the Whatkins scale by 1-2 points	24 months

External Links

•   official site
•   russian surcoma group site