Using preoperative radiotherapy and surgery for treating soft tissue sarcoma in limbs

Safety and Efficacy of Preoperative Stereotactic Body Radiotherapy (SBRT) and Radical Surgery for Soft Tissue Sarcoma of Extremities

This study is testing if giving radiation therapy before surgery can help people with large or difficult-to-remove soft tissue tumors in their arms or legs feel better and have better outcomes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06760221 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and effectiveness of preoperative stereotactic body radiotherapy (SBRT) followed by radical surgery in patients with high-grade soft tissue sarcomas of the extremities. It focuses on tumors larger than 5 cm or those with challenging surgical margins due to nearby blood vessels or nerves. The study is designed as a multicenter, prospective, single-arm trial, aiming to assess surgical safety, quality of life, and tumor control outcomes. Participants will undergo SBRT before surgery to optimize treatment efficacy and minimize risks.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with confirmed high-grade soft tissue sarcomas that are not amenable to immediate surgery.

Not a fit: Patients with small, low-grade tumors or those who have already received other antitumor therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve surgical outcomes and quality of life for patients with high-grade soft tissue sarcomas.

How similar studies have performed: While the effectiveness of preoperative SBRT is still being evaluated, similar approaches in other studies have shown promising results in improving surgical outcomes.

Eligibility criteria

Inclusion Criteria:

1. Aged ≥18 years;
2. Confirmed diagnosis of soft tissue sarcomas;
3. Highly malignant soft tissue sarcomas;
4. Not received surgery, chemotherapy or other antitumor therapy;
5. ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1;
6. Signed informed consent;
7. Willing to provide tissue from an excisional biopsy of a tumor lesion，willing to provide blood sample before and after treatment;

Exclusion Criteria:

1. Patients with soft tissue sarcoma of extremities with shallow tumor location, small size, low grade pathology and operable surgical resection;
2. Distant metastasis;
3. Received surgery or chemotherapy or other antitumor therapy;
4. Previously participated in other clinical trials;
5. History of severe allergies, patients with allergic conditions, such as contrast agent allergy;
6. Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer.
7. Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy;
8. Active infection requiring systemic therapy;
9. Known psychiatric or substance abuse disorders ;
10. Pregnant or breastfeeding;
11. Known history of human immunodeficiency virus (HIV: HIV 1/2 antibodies);
12. Received a live vaccine within 30 days before radiotherapy.
13. Unable to lie flat.

Where this trial is running

Hangzhou, Zhejiang

• the second affiliated hospital of Zhejiang University Hangzhou, Zhejiang, China, 310009 — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Qichun Wei, MD/PhD — Zhejiang University
• Study coordinator: Haiyan Chen, MD/PhD

Conditions Soft Tissue Sarcoma; Stereotactic Body Radiotherapy; Surgery