The Safety and Efficacy of Combined Microwave Ablation During Limb-sparing Surgery in High-risk Soft Tissue Sarcoma Patients

Not Applicable

Completed

• Conditions: Sarcoma; Microwave; Ablation Techniques

• Registration Number: NCT06802510
• Lead Sponsor: Guangdong Provincial People's Hospital

Brief Summary

Soft tissue sarcoma (STS) is a rare, aggressive malignancy with a high risk of recurrence when invading surrounding structures, and the optimal treatment strategy for safe surgical margin is still unclear. This study aimed to evaluate the safety and efficacy of combined local inactivation by ablation in STS during limb-sparing surgery in high-risk STS patients.

Detailed Description

Soft tissue sarcoma (STS) is a rare, aggressive malignancy with a high risk of recurrence when invading surrounding structures, and the optimal treatment strategy for safe surgical margin is still unclear. This study aimed to evaluate the safety and efficacy of combined local inactivation by ablation in STS during limb-sparing surgery in high-risk STS patients. Investigators collected data retrospectively from participants diagnosed with soft tissue sarcoma who were treated at a tertiary medical institution from January 1, 2018, to December 31, 2022. This study was approved by the hospital's Ethics Committee (XJS2022-101-01), and all participants provided written informed consent. The participants were divided into two groups (MWA and control group). The MWA group received surgical resection combined with local lesion inactivation by MWA, while the control group underwent standard surgical resection alone. Non-specified sarcomas are treated with the AI(Doxorubicin+Ifosfamide) chemotherapy regimen, while Ewing's sarcoma is treated with the standard recommended VDC ((Vincristine + Doxorubicin + Cyclophosphamide)/IE(Ifosfamide + Etoposide) chemotherapy regimen.

Study Timeline

• Study Start: 2018-01-21
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-01
• Study First Submitted: 2025-01-21
• Study First Submitted QC: 2025-01-25
• Last Update Submitted: 2025-01-25
• Study First Posted: 2025-01-31
• Last Update Posted: 2025-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

1. Pathologically confirmed soft tissue sarcoma (FNCLCC grade G2-G3);
2. MRI/CT confirmed tumor invasion beyond anatomical compartments, joint involvement, or encroachment on surrounding tissues (bones, muscle, etc.);
3. After being fully informed of the risks, the patient strongly refuses amputation or wide resection, which leads to irreversible impaired function.
4. Good physical condition, able to tolerate surgery;

Exclusion Criteria

1. Patients with distant metastasis at the time of initial diagnosis;
2. Patients with missing clinical or follow-up data.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	From date of diagnosis until the date of documented death, assessed up to 5 years (up to 5 year)	Overall survival was defined as the time from diagnosis to last follow-up or death.
progression-free survival (PFS)	From date of surgery until the date of first documented disease progression or death, assessed up to 5 years	progression-free survival (PFS) was the time from surgery to disease progression or death
Local disease-free survival (DFS)	From date of surgery until the date of first documented local tumor recurrence, assessed up to 5 years	Local disease-free survival (DFS) was the time for local tumor recurrence after surgery.

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	Post-operation 3 months	Serious postoperative complications were recorded according to CTCAE 4.0, including severe wound healing problems, deep infections, bone necrosis, wound burn, persistent pain, and major neurovascular injuries.

Trial Locations

Locations (1)

Guangdong provincial people's hospital; 🇨🇳 Guangzhou, Guangdong, China