NCT06760221Recruiting
Safety and Efficacy of Preoperative SBRT and Radical Surgery for Soft Tissue Sarcoma of Extremities
Safety and Efficacy of Preoperative Stereotactic Body Radiotherapy (SBRT) and Radical Surgery for Soft Tissue Sarcoma of Extremities
Source: ClinicalTrials.gov · Last updated 6 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 29 Dec 2024
- Start date
- 23 Mar 2023
- Primary completion date
- 1 Apr 2027
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Diseases
- Sarcoma
- NCT number
- NCT06760221
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 23 Mar 2023 to the primary completion date, 1 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with soft tissue sarcoma of extremities with shallow tumor location, small size, low grade pathology and operable surgical resection;
- Received surgery or chemotherapy or other antitumor therapy;
- Previously participated in other clinical trials;
- Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy;
- Received a live vaccine within 30 days before radiotherapy.
Other illness
- 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.
- Active infection requiring systemic therapy;
- Known psychiatric or substance abuse disorders ;
- Known history of human immunodeficiency virus (HIV: HIV 1/2 antibodies);
Other
- Distant metastasis;
- Pregnant or breastfeeding;
- Unable to lie flat.
Who the study is looking for
- 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;
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| the second affiliated hospital of Zhejiang University Hangzhou, Zhejiang, China, 310009 Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.