RecruitingNot ApplicableNCT06760221

Safety and Efficacy of Preoperative SBRT and Radical Surgery for Soft Tissue Sarcoma of Extremities

Safety and Efficacy of Preoperative Stereotactic Body Radiotherapy (SBRT) and Radical Surgery for Soft Tissue Sarcoma of Extremities


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

20 participants

Start Date

Mar 23, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Currently, the effectiveness and safety of preoperative hypo-fractionated radiotherapy in treating extremity soft tissue sarcomas remain inconclusive, warranting further investigation. Optimizing the neoadjuvant radiotherapy approach, including fractionation schedules and the interval between radiotherapy and surgery, is crucial to enhancing clinical efficacy while ensuring safety. This study proposes a multicenter, prospective, single-arm clinical trial utilizing preoperative SBRT for patients with high-grade extremity STS, tumors larger than 5 cm, or cases where achieving safe surgical margins is challenging due to involvement of surrounding blood vessels or nerves. The trial aims to preliminarily assess the impact of preoperative SBRT followed by radical surgery on surgical safety, quality of life, and tumor control in these patients.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving targeted radiation (called SBRT) before surgery leads to better outcomes for people with aggressive soft tissue sarcomas (cancer of the muscles or connective tissue) in their arms or legs. **You may be eligible if...** - You are 18 or older - You have been diagnosed with a high-grade (aggressive) soft tissue sarcoma in your arm or leg - You have NOT yet had surgery, chemotherapy, or any other cancer treatment - You are in good overall health (able to care for yourself and do light activity) - You are willing to provide tumor tissue and blood samples **You may NOT be eligible if...** - Your sarcoma is small, low-grade, or near the skin surface and can be removed with simple surgery - The cancer has spread to other parts of your body - You have already had surgery or cancer treatment - You have HIV, are pregnant or breastfeeding, or have an active infection - You cannot lie flat (required for radiation treatment) - You have a serious immune system condition 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.

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Interventions

RADIATIONstereotactic body raiotherapy

Neoadjuvant stereotactic body radiation therapy followed by radical surgery for soft tissue sarcoma.


Locations(1)

the second affiliated hospital of Zhejiang University Hangzhou, Zhejiang, China, 310009

Hangzhou, Zhejiang, China

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NCT06760221


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