Outcomes Comparison Between Bone Resection and Subperiosteal Dissection for Specific Type of Soft Tissue Sarcoma

Completed

• Conditions: Soft Tissue Sarcoma; Cortical Contact
• Interventions: Procedure: bone resection; Procedure: subperiosteal excision

• Registration Number: NCT06317480
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

the purpose of this study is to assess whether bone resection for thigh soft tissue sarcoma with cortical involvement of the adjacent bone result in better local control and survival compared to sub-periosteal dissection. Investigators also aim to find out the prognostic factors for clinical outcomes in this group of patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-05-01
• Primary Completion: 2020-05-01
• Study Completion: 2023-09-01
• Status Verified: 2024-02
• Study First Submitted: 2024-03-04
• Study First Submitted QC: 2024-03-11
• Last Update Submitted: 2024-03-11
• Study First Posted: 2024-03-19
• Last Update Posted: 2024-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

1. Patients developed thigh soft tissue sarcoma, defined as lesion located below the plane of the lesser trochanter and above the plane of the femoral condyle.
2. received primary limb-salvage surgery at our center.
3. soft tissue sarcoma with only cortical contact of the adjacent bone based on preoperative imaging
4. minimum of 2-year follow up

Exclusion Criteria

1. diagnosis was well differentiated liposarcoma
2. patients with metastatic disease at the time of presentation
3. soft tissue sarcoma displayed frank osseous invasion (eg. medullary canal invasion)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
bone resection	bone resection	-
subperiosteal excision	subperiosteal excision	-

Primary Outcome Measures

Name	Time	Method
recurrence	patients were checked every three months for the initial two years after surgery and every 6 months for the subsequent three years. After 5 years, patients will be checked once every year until patients died or were oss to follow up.	whether patients developed local recurrence
metastasis	patients were checked every three months for the initial two years after surgery and every 6 months for the subsequent three years. After 5 years, patients will be checked once every year until they died or were loss to follow up.	whether patients developed metastasis
survival	patients were checked every three months for the initial two years after surgery and every 6 months for the subsequent three years. After 5 years, patients will be checked once every year until patients died or were loss to follow up.	Whether patient die or not

Secondary Outcome Measures

Name	Time	Method
functional outcomes	MSTS scores were measured every 6 months for the first two years after surgery. After that, MSTS outcomes were measured once every year until patients died or were loss to follow up.	The Musculoskeletal Tumor Society (MSTS) questionnaire for the lower extremity is composed of six items including pain, function, emotional acceptance, use of any external support, walking ability, and gait alteration. Each item is rated in a scale of 0-5. The total score ranges from 0 to 30, with higher scores indicating better function.