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

NCT ID: NCT06760221

Last Updated: 2025-01-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-23
• Study Completion Date: 2029-12-31

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.

Conditions

Soft Tissue Sarcoma; Stereotactic Body Radiotherapy; Surgery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

radiotherapy

neoadjuvant stereotactic body radiation therapy followed by radical surgery

Group Type: EXPERIMENTAL

stereotactic body raiotherapy

Intervention Type: RADIATION

Neoadjuvant stereotactic body radiation therapy followed by radical surgery for soft tissue sarcoma.

Interventions

stereotactic body raiotherapy

Neoadjuvant stereotactic body radiation therapy followed by radical surgery for soft tissue sarcoma.

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Bengbu Medical University

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qichun Wei, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang University

Locations

the second affiliated hospital of Zhejiang University Hangzhou, Zhejiang, China, 310009

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Haiyan Chen, MD/PhD

Role: CONTACT

chenhaiyan@zju.edu.cn

+8657187783521

Facility Contacts

Qichun Wei, MD/PhD

Role: primary

qichun_wei@zju.edu.cn

+86 571 87783521

Haiyan Chen, MD/PhD

Role: backup

chenhaiyan@zju.edu.cn

+86 571 87783521

Other Identifiers

2023-0177

Identifier Type: -

Identifier Source: org_study_id