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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: chenhaiyan@zju.edu.cn
• Phone: +8657187783521

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.