Actively Recruiting
Preoperative Spatially Fractionated Radiation Therapy (SFRT) in Soft Tissue Sarcoma (neoSFRT-SARC)
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-03-30
22
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this prospective, single-arm, phase II trial is to evaluate whether a preoperative regimen combining spatially fractionated radiation therapy (SFRT) with subsequent surgery can improve outcomes in patients with large (≥5 cm) limb/trunk soft tissue sarcoma (STS). Currently, there is a lack of standardized SFRT-based protocols for operable or borderline-resectable large STS, and optimal dose-fractionation schedules, timing to surgery, differential efficacy by resectability status, and the induced systemic immune response remain undefined. Patients will receive 5 fractions of SFRT to the primary tumor, followed by definitive surgery. The main questions are: * Can this SFRT-first approach increase the 1-year disease-free survival (DFS) compared with historical controls? * What are the pathologic complete response (pCR) rate, overall survival (OS), and treatment-related safety profile? * What immune mechanisms are engaged by SFRT, as reflected by dynamic changes in peripheral immune cell subsets and cytokines? Participants will undergo SFRT, then surgery, with serial blood sampling for immune monitoring.
CONDITIONS
Official Title
Preoperative Spatially Fractionated Radiation Therapy (SFRT) in Soft Tissue Sarcoma (neoSFRT-SARC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed soft tissue sarcoma of the extremity or trunk, with tumor size 5 cm in greatest dimension by imaging or clinical examination
- Disease classified as operable or borderline-resectable by a multidisciplinary tumor board
- Age 18 years or older at the time of consent
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Adequate organ function including absolute neutrophil count 61.5 7109/L, platelet count 6100 7109/L, hemoglobin 69.0 g/dL, total bilirubin 61.5 times upper limit of normal (ULN) or 63 times ULN in Gilbert's syndrome, AST/ALT 62.5 times ULN, creatinine clearance 650 mL/min
- Women of childbearing potential must have negative pregnancy test within 7 days prior to enrollment and agree to use effective contraception during treatment and 3 months after last procedure
- Men with partners of childbearing potential must agree to use effective contraception during treatment and 3 months after last procedure
- Willing and able to provide written informed consent and comply with study procedures including follow-up and blood sample collection
You will not qualify if you...
- Prior radiotherapy to the same anatomical site resulting in overlapping radiation fields
- Presence of distant metastases (M1 disease) at enrollment
- Pregnant or breastfeeding
- Active second malignancy requiring systemic therapy within past 3 years except treated basal cell carcinoma, squamous cell carcinoma of skin, or carcinoma in situ
- Severe, active comorbidities such as uncontrolled infection requiring IV antibiotics, decompensated heart failure (NYHA Class III or IV), myocardial infarction or unstable angina within 6 months, severe chronic obstructive pulmonary disease or other conditions precluding safe radiotherapy or surgery
- Known hypersensitivity to radiation therapy or inability to undergo required imaging (e.g., MRI contrast allergy not manageable with premedication)
- Participation in another interventional clinical trial with investigational agent within 30 days prior to enrollment
- Any condition compromising patient safety, study compliance, or successful study completion as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
2nd Affiliated Hospital, School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
T
Ting Zhang, phD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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