Actively Recruiting
Safety and Efficacy of Preoperative SBRT and Radical Surgery for Soft Tissue Sarcoma of Extremities
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-01-06
20
Participants Needed
1
Research Sites
353 weeks
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead Sponsor
T
The First Affiliated Hospital of Bengbu Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy of Preoperative SBRT and Radical Surgery for Soft Tissue Sarcoma of Extremities
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- Confirmed diagnosis of soft tissue sarcomas
- High-grade (highly malignant) soft tissue sarcomas
- No prior surgery, chemotherapy, or other antitumor therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Signed informed consent
- Willing to provide tissue from an excisional biopsy and blood samples before and after treatment
You will not qualify if you...
- Soft tissue sarcoma with shallow tumor location, small size, low-grade pathology, and operable by surgery
- Presence of distant metastasis
- Prior surgery, chemotherapy, or other antitumor therapy
- Previous participation in other clinical trials
- History of severe allergies, including contrast agent allergy
- Active additional malignancy requiring treatment (exceptions: treated basal cell or squamous cell skin cancer, or in situ cervical cancer)
- Diagnosis of immunodeficiency or current systemic steroid or immunosuppressive therapy
- Active infection requiring systemic treatment
- Known psychiatric or substance abuse disorders
- Pregnant or breastfeeding
- Known HIV infection
- Received a live vaccine within 30 days before radiotherapy
- Unable to lie flat during treatment
AI-Screening
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Trial Site Locations
Total: 1 location
1
the second affiliated hospital of Zhejiang University Hangzhou, Zhejiang, China, 310009
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
H
Haiyan Chen, MD/PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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