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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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 criteria

Qualifiers

Aged ≥18 years;

Confirmed diagnosis of soft tissue sarcomas;

Highly malignant soft tissue sarcomas;

Not received surgery, chemotherapy or other antitumor therapy;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • stereotactic body raiotherapy

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

The First Affiliated Hospital of Bengbu Medical University

Collaborator