OncoMatch/Clinical Trials/NCT07501026
Preoperative Spatially Fractionated Radiation Therapy (SFRT) in Soft Tissue Sarcoma (neoSFRT-SARC)
Is NCT07501026 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies non-drug interventions for sarcoma.
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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Sarcoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: radiation therapy
Exception: to the same anatomical site that would result in overlap of radiation fields
Prior radiotherapy to the same anatomical site that would result in overlap of radiation fields
Lab requirements
Blood counts
absolute neutrophil count ≥1.5 × 10⁹/l; platelet count ≥100 × 10⁹/l; hemoglobin ≥9.0 g/dl
Kidney function
creatinine clearance ≥50 ml/min (by cockcroft-gault or measured)
Liver function
total bilirubin ≤1.5 × uln (or ≤3 × uln in patients with gilbert's syndrome); ast/alt ≤2.5 × uln
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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