Clinical trial NCT06317480: Outcomes Comparison Between Bone Resection and Subperiosteal Dissection for Specific Type of Soft Tissue Sarcoma
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?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Soft Tissue Sarcoma
Cortical Contact
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 142
Sex: ALL
Minimum age (years): 8
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: survival
timeFrame: 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.
measure: recurrence
timeFrame: 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.
measure: metastasis
timeFrame: 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 outcomes:
measure: functional outcomes
timeFrame: 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.
Other outcomes:
Locations:
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Zhaoming Ye
role: PRINCIPAL_INVESTIGATOR
References: