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

NCT06760221 | Recruiting

• 1 other identifier: 2023-0177
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Soft Tissue Sarcoma; Stereotactic Body Radiotherapy; Surgery

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of radiotherapy followed by radical surgery

  Incidence of Treatment-Emergent Adverse events (CTCAE v5.0)

  120 days after radical surgery

Secondary Outcomes (4)

• Extremity function and Quality of life by EORTC QLQ-C30

  Assessed up to 12 months

• Recurrence free survival

  1-,2-,3-year after radical surgery

• Progression free survival

  1-,2-,3-year after radical surgery

• Overall survival

  1-,2-,3-year after radical surgery

Study Arms (1)

radiotherapy

EXPERIMENTAL

neoadjuvant stereotactic body radiation therapy followed by radical surgery

Radiation: stereotactic body raiotherapy

Interventions

stereotactic body raiotherapy RADIATION

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

radiotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with soft tissue sarcoma of extremities with shallow tumor location, small size, low grade pathology and operable surgical resection;
• Distant metastasis;
• Received surgery or chemotherapy or other antitumor therapy;
• Previously participated in other clinical trials;
• History of severe allergies, patients with allergic conditions, such as contrast agent allergy;
• 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.
• Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy;
• Active infection requiring systemic therapy;
• Known psychiatric or substance abuse disorders ;
• Pregnant or breastfeeding;
• Known history of human immunodeficiency virus (HIV: HIV 1/2 antibodies);
• Received a live vaccine within 30 days before radiotherapy.
• Unable to lie flat.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• The First Affiliated Hospital of Bengbu Medical University: collaborator

Study Sites (1)

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

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Qichun Wei, MD/PhD

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haiyan Chen, MD/PhD

CONTACT

+8657187783521; chenhaiyan@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: neoadjuvant stereotactic body radiation therapy followed by radical surgery

Study Record Dates

• First Submitted: December 29, 2024
• First Posted: January 6, 2025
• Study Start: March 23, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: January 6, 2025

Record last verified: 2024-12

Locations

CN (1)