Soft Tissue SarcomaNCT06317480
Outcomes Comparison Between Bone Resection and Subperiosteal Dissection for Specific Type of Soft Tissue Sarcoma
An observational study of Soft Tissue Sarcoma and Cortical Contact, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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. Read more about this study
- Who is it for?
- Ages 8 to 85 years
- Conditions the study is for
- Soft Tissue Sarcoma, Cortical Contact
- What is being tested?
- bone resection and subperiosteal excision
- Type of treatment
- Surgery or procedure
- How many people
- 142 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2000to 1 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
About this study
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?
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.
- Conditions
- Soft Tissue Sarcoma, Cortical Contact
- Being tested
- bone resection, subperiosteal excision
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bone resectionProcedure or surgery
patients underwent soft tissue sarcoma excision together with bone resection following either biological or endoprosthesis reconstruction
subperiosteal excisionProcedure or surgery
patients underwent sub-periosteal tumor excision combining bone and soft tissue ablation without bone excision
| Study group | Role | What they receive |
|---|---|---|
| bone resection | Not described Receives: Procedure: bone resection | |
| subperiosteal excision | Not described Receives: Procedure: subperiosteal excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival
Whether patient die or not
Measured: 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
Measured: 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
Measured: 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 (1)
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start1 May 2000
- Primary completion1 May 2020
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhaoming Ye, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06317480
- Sponsor's protocol ID
- QH_2024
- Status last verified
- Feb 2024
- First submitted
- 4 Mar 2024
- Last updated
- 19 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT06317480
- Acronym / sponsor ID
- QH_2024
- Conditions
- Soft Tissue Sarcoma, Cortical Contact
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 May 2000 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bone resection | – | Procedure: bone resection |
| subperiosteal excision | – | Procedure: subperiosteal excision |
Who may qualify
- Ages
- 8 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bone resectionpatients underwent soft tissue sarcoma excision together with bone resection following either biological or endoprosthesis reconstruction | Procedure or surgery | bone resection |
| subperiosteal excisionpatients underwent sub-periosteal tumor excision combining bone and soft tissue ablation without bone excision | Procedure or surgery | subperiosteal excision |
Primary outcome
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
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
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
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhaoming Ye principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Soft Tissue Sarcoma and Cortical Contact, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.