Actively Recruiting
Safety and Efficacy of Preoperative Stereotactic Body Radiotherapy and Radical Surgery for Soft Tissue Sarcoma of the 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
Researchers are investigating the safety and effectiveness of preoperative hypo-fractionated radiotherapy for treating high-grade soft tissue sarcomas (STS) of the extremities. These tumors are larger than 5 cm or involve surrounding blood vessels or nerves, which makes achieving safe surgical margins difficult. The study aims to evaluate how preoperative stereotactic body radiotherapy (SBRT) followed by radical surgery impacts surgical safety, quality of life, and tumor control. Participants will receive neoadjuvant stereotactic body radiation therapy before undergoing radical surgery to remove the tumor. This is a multicenter, prospective, single-arm clinical trial focused on the treatment sequence of SBRT followed by surgery. The goal is to optimize radiotherapy schedules and the timing between radiation and surgery to improve outcomes while maintaining safety. During the study, participants will be closely monitored for safety and tolerability, especially within 120 days after surgery. Researchers will assess tumor control, surgical outcomes, and quality of life. Tissue samples from tumor biopsies and blood samples will be collected before and after treatment to support study evaluations. The total duration includes treatment and follow-up to ensure comprehensive assessment of safety and effectiveness.
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
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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
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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