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

Not Applicable

Recruiting

• Conditions: Soft Tissue Sarcoma; Stereotactic Body Radiotherapy; Surgery

• Registration Number: NCT06760221
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2023-03-23
• Status Verified: 2024-12
• Study First Submitted: 2024-12-29
• Study First Submitted QC: 2024-12-29
• Last Update Submitted: 2024-12-29
• Study First Posted: 2025-01-06
• Last Update Posted: 2025-01-06
• Primary Completion: 2027-04-01
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of radiotherapy followed by radical surgery	120 days after radical surgery	Incidence of Treatment-Emergent Adverse events (CTCAE v5.0)

Secondary Outcome Measures

Name	Time	Method
Recurrence free survival	1-,2-,3-year after radical surgery	From date of enrollment to the date of first documented recurrence
Progression free survival	1-,2-,3-year after radical surgery	from date of enrollment to the date of first documented progression
Extremity function and Quality of life by EORTC QLQ-C30	Assessed up to 12 months	1 year after radical surgery
Overall survival	1-,2-,3-year after radical surgery	from date of enrollment to the date of death from any cause

Trial Locations

Locations (1)

the second affiliated hospital of Zhejiang University Hangzhou, Zhejiang, China, 310009; 🇨🇳 Hangzhou, Zhejiang, China