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;
Patients with soft tissue sarcoma of extremities with shallow tumor location, small size, low grade pathology and operable surgical resection;
Distant metastasis;
Received surgery or chemotherapy or other antitumor therapy;
Previously participated in other clinical trials;
Single group
stereotactic body raiotherapy
RadiationNeoadjuvant stereotactic body radiation therapy followed by radical surgery for soft tissue sarcoma.
Safety and tolerability of radiotherapy followed by radical surgery
Incidence of Treatment-Emergent Adverse events (CTCAE v5.0)
Extremity function and Quality of life by EORTC QLQ-C30
1 year after radical surgery
Recurrence free survival
From date of enrollment to the date of first documented recurrence
Progression free survival
from date of enrollment to the date of first documented progression
Overall survival
from date of enrollment to the date of death from any cause
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Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead sponsor
The First Affiliated Hospital of Bengbu Medical University
Collaborator
