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Completed

NCT Number: NCT06317480

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

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.

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Key information

Conditions

Soft Tissue Sarcoma Cortical Contact Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Sarcoma

Age range

8 year–85 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • received primary limb-salvage surgery at our center.
  • soft tissue sarcoma with only cortical contact of the adjacent bone based on preoperative imaging
  • minimum of 2-year follow up

Exclusion criteria

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

Treatment and study plan

bone resection

Procedure

patients underwent soft tissue sarcoma excision together with bone resection following either biological or endoprosthesis reconstruction

subperiosteal excision

Procedure

patients underwent sub-periosteal tumor excision combining bone and soft tissue ablation without bone excision

Primary outcomes

  1. survival

    Time frame: 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

  2. recurrence

    Time frame: 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

  3. metastasis

    Time frame: 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

Secondary outcomes

  1. functional outcomes

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2020
Study completion
2023
First posted
Mar 19, 2024
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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