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NCT Number: NCT06802510

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

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.

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Key information

Conditions

Sarcoma Ablation Techniques Microwave Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangdong provincial people's hospital

Guangzhou, Guangdong, 516008, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Microwave ablation

Procedure

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.

Primary outcomes

  1. 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.

  2. 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

  3. 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

  1. 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.

Sponsors and collaborators

Lead sponsor

Guangdong Provincial People's Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Jan 31, 2025
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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