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

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study ID
NCT06760221
Status
Recruiting
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Conditions

  • Soft Tissue Sarcoma
  • Stereotactic Body Radiotherapy
  • Surgery

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • stereotactic body raiotherapy — RADIATION
    Neoadjuvant stereotactic body radiation therapy followed by radical surgery for soft tissue sarcoma.

Study Details

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.

Key Dates

First listed
Jan 6, 2025
Start date
Mar 23, 2023
Status verified
Dec 2024
Primary completion
Apr 1, 2027
Completion
Dec 31, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: radiotherapy
    neoadjuvant stereotactic body radiation therapy followed by radical surgery

Primary Outcome Measure

Safety and tolerability of radiotherapy followed by radical surgery [ Time Frame: 120 days after radical surgery ]

Central Contacts

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