Safety and Efficacy of Preoperative Stereotactic Body Radiotherapy (SBRT) and Radical Surgery for Soft Tissue Sarcoma of Extremities
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.
• Aged ≥18 years;
• Confirmed diagnosis of soft tissue sarcomas;
• Highly malignant soft tissue sarcomas;
• Not received surgery, chemotherapy or other antitumor therapy;
• ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1;
• Signed informed consent;
• Willing to provide tissue from an excisional biopsy of a tumor lesion，willing to provide blood sample before and after treatment;