NCT05057195

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Blokhin's Russian Cancer Research Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Sarcoma
• Soft Tissue Sarcoma

Interventions

Type	Name	Description
RADIATION	Interstitial radiation therapy	From 30 to 50 Gy,
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

Timeline

• Start date: 2022-01-10
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2021-09-27
• Last updated: 2024-04-01

Locations

1 site across 1 country: Russia