Clinical trial NCT06802510: The Safety and Efficacy of Combined Microwave Ablation During Limb-sparing Surgery in High-risk Soft Tissue Sarcoma Patients
Official title: The Safety and Efficacy of Combined Microwave Ablation During Limb-sparing Surgery in High-risk Soft Tissue Sarcoma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcoma
Microwave
Ablation Techniques
Keywords: sarcoma
microwave ablation
limb-sparing surgery
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 44
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Retrospective controlled study
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival (OS)
timeFrame: From date of diagnosis until the date of documented death, assessed up to 5 years (up to 5 year)
measure: progression-free survival (PFS)
timeFrame: From date of surgery until the date of first documented disease progression or death, assessed up to 5 years
measure: Local disease-free survival (DFS)
timeFrame: From date of surgery until the date of first documented local tumor recurrence, assessed up to 5 years
Secondary outcomes:
measure: Postoperative complications
timeFrame: Post-operation 3 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong provincial people's hospital
state: Guangdong
Study officials:
References: