NCT06760221 Safety and Efficacy of Preoperative SBRT and Radical Surgery for Soft Tissue Sarcoma of Extremities
| NCT ID | NCT06760221 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Soft Tissue Sarcoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-03-23 |
| Primary Completion | 2027-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2023-03-23 with a primary completion date of 2027-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Aged ≥18 years; 2. Confirmed diagnosis of soft tissue sarcomas; 3. Highly malignant soft tissue sarcomas; 4. Not received surgery, chemotherapy or other antitumor therapy; 5. ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1; 6. Signed informed consent; 7. Willing to provide tissue from an excisional biopsy of a tumor lesion，willing to provide blood sample before and after treatment; Exclusion Criteria: 1. Patients with soft tissue sarcoma of extremities with shallow tumor location, small size, low grade pathology and operable surgical resection; 2. Distant metastasis; 3. Received surgery or chemotherapy or other antitumor therapy; 4. Previously participated in other clinical trials; 5. History of severe allergies, patients with allergic conditions, such as contrast agent allergy; 6. 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. 7. Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy; 8. Active infection requiring systemic therapy; 9. Known psychiatric or substance abuse disorders ; 10. Pregnant or breastfeeding; 11. Known history of human immunodeficiency virus (HIV: HIV 1/2 antibodies); 12. Received a live vaccine within 30 days before radiotherapy. 13. Unable to lie flat.
Contact & Investigator
Qichun Wei, MD/PhD
PRINCIPAL INVESTIGATOR
Zhejiang University
Frequently Asked Questions
Who can join the NCT06760221 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Soft Tissue Sarcoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06760221 currently recruiting?
Yes, NCT06760221 is actively recruiting participants. Contact the research team at chenhaiyan@zju.edu.cn for enrollment information.
Where is the NCT06760221 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06760221 clinical trial?
NCT06760221 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The principal investigator is Qichun Wei, MD/PhD at Zhejiang University. The trial plans to enroll 20 participants.