Preoperative Spatially Fractionated Radiation Therapy (SFRT) in Soft Tissue Sarcoma (neoSFRT-SARC)

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study ID
NCT07501026
Phase
PHASE2
Status
Recruiting
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Conditions

  • Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • SFRT — RADIATION
    1. Preoperative SFRT: The prescribed dose is 20 Gy in 5 fractions, with lattice dose of 66.7Gy in 5 fractions. 2. Surgery: Approximately one week after completion of SFRT, tumor resectability is reassessed. Patients who achieve sufficient tumor response undergo definitive surgical resection. Those who remain unsuitable for surgery after SFRT will receive alternative treatment per standard of care. 3. Translational immune monitoring: Peripheral blood samples are collected at baseline, one week post-SFRT, and at 1, 3, 6, and 12 months post-treatment for exploratory analysis of immune cell subsets (e.g., CD8⁺ T cells) and cytokine profiles (e.g., IFN-γ, TNF-α), aimed at characterizing SFRT-induced systemic immune modulation.

Study Details

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.

Key Dates

First listed
Mar 30, 2026
Start date
Mar 16, 2026
Status verified
Mar 2026
Primary completion
Mar 16, 2028
Completion
Mar 16, 2029

Study Design

Enrollment
22 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Preoperative SFRT
    SFRT Administration: All patients will first receive preoperative SFRT. Regimen: Total dose PTV 66.7 (lattice) / 20 Gy, delivered in 5 fractions (the fractionation pattern will be individually optimized based on tumor location and adjacent organs to ensure that doses to critical structures remain within safe limits).

Primary Outcome Measure

1-year Disease-Free Survival (DFS) [ Time Frame: 1 year post-treatment ]

Central Contacts

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