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

Does Composite Bone Resection for Soft Tissue Sarcoma With Cortical Contact Result in Better Local Control and Survival Compared to Sub-periosteal Dissection?

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.

Study Overview

• Status: Completed
• Conditions: Soft Tissue Sarcoma; Cortical Contact
• Intervention / Treatment: Procedure: bone resection; Procedure: subperiosteal excision

• Study Type: Observational
• Enrollment (Actual): 142

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients displayed with thigh soft tissue sarcoma with only cortical contact of the adjacent bone and underwent limb-salvage surgery were included for the study. Patients could be divided into two groups: 1) sub-periosteal tumor excision group and 2) composite bone resection and reconstruction group.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
bone resection	Procedure: bone resection; patients underwent soft tissue sarcoma excision together with bone resection following either biological or endoprosthesis reconstruction
subperiosteal excision	Procedure: subperiosteal excision; patients underwent sub-periosteal tumor excision combining bone and soft tissue ablation without bone excision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
survival	Whether patient die or not	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.
recurrence	whether patients developed local 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.
metastasis	whether patients developed 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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
functional outcomes	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.	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.

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Zhaoming Ye, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2000
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 11, 2024
• First Posted (Actual): March 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma
• Other Study ID Numbers: QH_2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No