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

Soft Tissue Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06317480
• Other study ID #: QH_2024
• Status: Completed
• Start date: May 1, 2000
• Est. completion date: September 1, 2023

Study information

• Verified date: February 2024
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: September 1, 2023
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Sarcoma

Intervention

Procedure:
• bone resection
patients underwent soft tissue sarcoma excision together with bone resection following either biological or endoprosthesis reconstruction
• subperiosteal excision
patients underwent sub-periosteal tumor excision combining bone and soft tissue ablation without bone excision

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.