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

January 25, 2025 updated by: Yu Zhang, PhD, Guangdong Provincial People's Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 516008
        • Guangdong Provincial People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MWA group
The MWA group received surgical resection combined with local lesion inactivation by MWA
Procedure: Microwave Ablation
The MWA group followed a similar resection procedure as the control group. The area of ablation was evaluated strictly by radiologists and surgeons according to the following criteria: 1) Areas of tumor response, progression, or suspicious invasion (intermediate-high signal and edema range in T2) were assessed. Wide margins of at least 2-3 cm or more were obtained over the normal tissue around the tumor. Ablation margins were covered using a microwave ablation array with antennas (Microwave Ablation System BD-GT, Baird Medical LLC), aimed at completely inactivating the tumor in situ. Ablation needles were strategically arranged to form a matrix covering the target zone. The ablation time and power were determined based on the extent of the lesion, ensuring the temperature of the ablation area remained between 70-80°C. A 50 ml syringe was used to continuously drip and spray ice-cold saline to keep surrounding tissue temperatures below 40-43°C.
No Intervention: Control group
The control group received standard surgical resection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From date of diagnosis until the date of documented death, assessed up to 5 years (up to 5 year)
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
From date of surgery until the date of first documented disease progression or death, assessed up to 5 years
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.
From date of surgery until the date of first documented local tumor recurrence, assessed up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: 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.
Post-operation 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Provincial People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2018

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

January 21, 2025

First Submitted That Met QC Criteria

January 25, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 25, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MWASTS001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to ethical and patient privacy restrictions, relevant data is not publicly disclosed

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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