Wide Excision of Soft Tissue Sarcomas in Combination With Interstitial Radiation Therapy
NCT05057195 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78
Last updated 2024-04-01
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
Conditions
- Sarcoma
- Soft Tissue Sarcoma
Interventions
- 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
Sponsors & Collaborators
-
Blokhin's Russian Cancer Research Center
lead OTHER
Principal Investigators
-
Aslan Valiev, PhD · N.N. Blokhin NMRCO
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-01-10
- Primary Completion
- 2025-12-31
- Completion
- 2025-12-31
Countries
- Russia
Study Locations
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