The Safety and Efficacy of Combined Microwave Ablation During Limb-sparing Surgery in High-risk Soft Tissue Sarcoma Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Overall survival (OS)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Pathologically confirmed soft tissue sarcoma (FNCLCC grade G2-G3);
- •MRI/CT confirmed tumor invasion beyond anatomical compartments, joint involvement, or encroachment on surrounding tissues (bones, muscle, etc.);
- •After being fully informed of the risks, the patient strongly refuses amputation or wide resection, which leads to irreversible impaired function.
- •Good physical condition, able to tolerate surgery;
Exclusion Criteria
- •Patients with distant metastasis at the time of initial diagnosis;
- •Patients with missing clinical or follow-up data.
Arms & Interventions
MWA group
The MWA group received surgical resection combined with local lesion inactivation by MWA
Intervention: Microwave Ablation (Procedure)
Control group
The control group received standard surgical resection.
Outcomes
Primary Outcomes
Overall survival (OS)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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 Outcomes
- Postoperative complications(Post-operation 3 months)
Investigators
Yu Zhang, PhD
Professor
Guangdong Provincial People's Hospital