RecruitingNot ApplicableNCT05057195

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


Sponsor

Blokhin's Russian Cancer Research Center

Enrollment

78 participants

Start Date

Jan 10, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether combining surgery (wide excision) with internal radiation therapy (interstitial brachytherapy — where radiation seeds are placed directly inside or near the tumor site) can effectively treat soft tissue sarcomas of the arms and legs while preserving the limb. **You may be eligible if...** - You have a soft tissue sarcoma in your arm (including shoulder) or leg (including hip), grade 2 or 3 - Your tumor is 7 cm or smaller - You have locally advanced or recurrent sarcoma with no spread to lymph nodes - You are 18 or older **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have certain specific sarcoma subtypes (e.g., Kaposi's sarcoma, chondrosarcoma, GIST) - Your tumor cannot be surgically removed or is breaking down (decaying) - You have skin damage in the affected area - You have another active cancer - You have an active chronic infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

RADIATIONInterstitial radiation therapy

From 30 to 50 Gy,

RADIATIONPostoperative 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(1)

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

Moscow, Russia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05057195


Related Trials