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

NCT06802510 | Completed DMC

• 1 other identifier: MWASTS001
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoma; Microwave; Ablation Techniques

Keywords

sarcoma; microwave ablation; limb-sparing surgery

Outcome Measures

Primary Outcomes (3)

• Overall survival (OS)

  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)

  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)

  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 Outcomes (1)

• Postoperative complications

  Post-operation 3 months

Study Arms (2)

MWA group

EXPERIMENTAL

The MWA group received surgical resection combined with local lesion inactivation by MWA

Procedure: Microwave Ablation

Control group

NO INTERVENTION

The control group received standard surgical resection.

Interventions

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.

MWA group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

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

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong provincial people's hospital

Guangzhou, Guangdong, 516008, China

Location

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Retrospective controlled study

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 31, 2025
• Study Start: January 21, 2018
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)