Soft Tissue SarcomaNCT06760221
Safety and Efficacy of Preoperative SBRT and Radical Surgery for Soft Tissue Sarcoma of Extremities
A study testing stereotactic body raiotherapy in people with Soft Tissue Sarcoma and Stereotactic Body Radiotherapy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Currently, the effectiveness and safety of preoperative hypo-fractionated radiotherapy in treating extremity soft tissue sarcomas remain inconclusive, warranting further investigation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Soft Tissue Sarcoma, Stereotactic Body Radiotherapy, Surgery
- What is being tested?
- stereotactic body raiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 23 Mar 2023to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18 years;
- Confirmed diagnosis of soft tissue sarcomas;
- Highly malignant soft tissue sarcomas;
- Not received surgery, chemotherapy or other antitumor therapy;
- ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1;
- Signed informed consent;
- Willing to provide tissue from an excisional biopsy of a tumor lesion，willing to provide blood sample before and after treatment;
Who cannot join
- Patients with soft tissue sarcoma of extremities with shallow tumor location, small size, low grade pathology and operable surgical resection;
- Distant metastasis;
- Received surgery or chemotherapy or other antitumor therapy;
- Previously participated in other clinical trials;
- History of severe allergies, patients with allergic conditions, such as contrast agent allergy;
- Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer.
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- Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy;
- Active infection requiring systemic therapy;
- Known psychiatric or substance abuse disorders ;
- Pregnant or breastfeeding;
- Known history of human immunodeficiency virus (HIV: HIV 1/2 antibodies);
- Received a live vaccine within 30 days before radiotherapy.
- Unable to lie flat.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the second affiliated hospital of Zhejiang University Hangzhou, Zhejiang, China, 310009
Hangzhou, Zhejiang
Qichun Wei, MD/PhD, +86 571 87783521, qichun_wei@zju.edu.cn
Haiyan Chen, MD/PhD, +86 571 87783521, chenhaiyan@zju.edu.cn
About this study
Official title: Safety and Efficacy of Preoperative Stereotactic Body Radiotherapy (SBRT) and Radical Surgery for Soft Tissue Sarcoma of Extremities
Currently, the effectiveness and safety of preoperative hypo-fractionated radiotherapy in treating extremity soft tissue sarcomas remain inconclusive, warranting further investigation. Optimizing the neoadjuvant radiotherapy approach, including fractionation schedules and the interval between radiotherapy and surgery, is crucial to enhancing clinical efficacy while ensuring safety. This study proposes a multicenter, prospective, single-arm clinical trial utilizing preoperative SBRT for patients with high-grade extremity STS, tumors larger than 5 cm, or cases where achieving safe surgical margins is challenging due to involvement of surrounding blood vessels or nerves. The trial aims to preliminarily assess the impact of preoperative SBRT followed by radical surgery on surgical safety, quality of life, and tumor control in these patients.
Read the detailed description
The effectiveness and safety of preoperative hypo-fractionated radiotherapy in treating extremity soft tissue sarcomas remain inconclusive, warranting further investigation. Optimizing the neoadjuvant radiotherapy approach, including fractionation schedules and the interval between radiotherapy and surgery, is crucial to enhancing clinical efficacy while ensuring safety. This study proposes a multicenter, prospective, single-arm clinical trial utilizing preoperative SBRT for patients with high-grade extremity STS, tumors larger than 5 cm, or cases where achieving safe surgical margins is challenging due to involvement of surrounding blood vessels or nerves. The trial aims to preliminarily assess the impact of preoperative SBRT followed by radical surgery on surgical safety, quality of life, and tumor control in these patients.
- Conditions
- Soft Tissue Sarcoma, Stereotactic Body Radiotherapy, Surgery
- Being tested
- stereotactic body raiotherapy
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stereotactic body raiotherapyRadiation
Neoadjuvant stereotactic body radiation therapy followed by radical surgery for soft tissue sarcoma.
| Study group | Role | What they receive |
|---|---|---|
| radiotherapy | Experimental | neoadjuvant stereotactic body radiation therapy followed by radical surgery Receives: Radiation: stereotactic body raiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of radiotherapy followed by radical surgery
Incidence of Treatment-Emergent Adverse events (CTCAE v5.0)
Measured: 120 days after radical surgery
Secondary outcomes (4)
Extremity function and Quality of life by EORTC QLQ-C30
1 year after radical surgery
Measured: Assessed up to 12 months
Recurrence free survival
From date of enrollment to the date of first documented recurrence
Measured: 1-,2-,3-year after radical surgery
Progression free survival
from date of enrollment to the date of first documented progression
Measured: 1-,2-,3-year after radical surgery
Overall survival
from date of enrollment to the date of death from any cause
Measured: 1-,2-,3-year after radical surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start23 Mar 2023
- Primary completion1 Apr 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- neoadjuvant stereotactic body radiation therapy followed by radical surgery
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Bengbu Medical University
- Responsible party
- Sponsor
- Investigators
- Qichun Wei, MD/PhD, Principal investigator, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760221
- Sponsor's protocol ID
- 2023-0177
- Status last verified
- Dec 2024
- First submitted
- 29 Dec 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Preoperative Stereotactic Body Radiotherapy (SBRT) and Radical Surgery for Soft Tissue Sarcoma of Extremities
- ClinicalTrials.gov ID
- NCT06760221
- Acronym / sponsor ID
- 2023-0177
- Conditions
- Soft Tissue Sarcoma, Stereotactic Body Radiotherapy, Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Bengbu Medical University
- Study start
- 23 Mar 2023 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 6 Jan 2025 (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.
Currently, the effectiveness and safety of preoperative hypo-fractionated radiotherapy in treating extremity soft tissue sarcomas remain inconclusive, warranting further investigation. Optimizing the neoadjuvant radiotherapy approach, including fractionation schedules and the interval between radiotherapy and surgery, is crucial to enhancing clinical efficacy while ensuring safety. This study proposes a multicenter, prospective, single-arm clinical trial utilizing preoperative SBRT for patients with high-grade extremity STS, tumors larger than 5 cm, or cases where achieving safe surgical margins is challenging due to involvement of surrounding blood vessels or nerves. The trial aims to preliminarily assess the impact of preoperative SBRT followed by radical surgery on surgical safety, quality of life, and tumor control in these patients.
Detailed description
The effectiveness and safety of preoperative hypo-fractionated radiotherapy in treating extremity soft tissue sarcomas remain inconclusive, warranting further investigation. Optimizing the neoadjuvant radiotherapy approach, including fractionation schedules and the interval between radiotherapy and surgery, is crucial to enhancing clinical efficacy while ensuring safety. This study proposes a multicenter, prospective, single-arm clinical trial utilizing preoperative SBRT for patients with high-grade extremity STS, tumors larger than 5 cm, or cases where achieving safe surgical margins is challenging due to involvement of surrounding blood vessels or nerves. The trial aims to preliminarily assess the impact of preoperative SBRT followed by radical surgery on surgical safety, quality of life, and tumor control in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- neoadjuvant stereotactic body radiation therapy followed by radical surgery
| Arm | Type | Receives |
|---|---|---|
| radiotherapy | Experimental | Radiation: stereotactic body raiotherapyneoadjuvant stereotactic body radiation therapy followed by radical surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged ≥18 years;
- Confirmed diagnosis of soft tissue sarcomas;
- Highly malignant soft tissue sarcomas;
- Not received surgery, chemotherapy or other antitumor therapy;
- ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1;
Key exclusion criteria (13 listed)
- Patients with soft tissue sarcoma of extremities with shallow tumor location, small size, low grade pathology and operable surgical resection;
- Distant metastasis;
- Received surgery or chemotherapy or other antitumor therapy;
- Previously participated in other clinical trials;
- History of severe allergies, patients with allergic conditions, such as contrast agent allergy;
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 |
|---|---|---|
| stereotactic body raiotherapyNeoadjuvant stereotactic body radiation therapy followed by radical surgery for soft tissue sarcoma. | Radiation | radiotherapy |
Primary outcome
Safety and tolerability of radiotherapy followed by radical surgery
Time frame: 120 days after radical surgery
Incidence of Treatment-Emergent Adverse events (CTCAE v5.0)
4 secondary outcomes
Extremity function and Quality of life by EORTC QLQ-C30
Time frame: Assessed up to 12 months
Recurrence free survival
Time frame: 1-,2-,3-year after radical surgery
Progression free survival
Time frame: 1-,2-,3-year after radical surgery
Overall survival
Time frame: 1-,2-,3-year after radical surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
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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.
Qichun Wei, MD/PhD principal investigator
Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stereotactic body raiotherapy in people with Soft Tissue Sarcoma and Stereotactic Body Radiotherapy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 7 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haiyan Chen, MD/PhD (+8657187783521, chenhaiyan@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of radiotherapy followed by radical surgery (time frame: 120 days after radical surgery). 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 6 Jan 2025.