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RECRUITING

NCT07501026

PHASE2

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

Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase II Prospective Study of Preoperative Spatially Fractionated Radiation Therapy (SFRT) in Soft Tissue Sarcoma (neoSFRT-SARC)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-03-16

Completion Date

2029-03-16

Last Updated

2026-03-30

Healthy Volunteers

Conditions

Sarcoma

Interventions

RADIATION

SFRT

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.

Inclusion Criteria: * 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 as determined by the multidisciplinary tumor board. * Age ≥18 years at the time of consent. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2. * Adequate organ function as defined by: Absolute neutrophil count ≥1.5 × 10⁹/L; Platelet count ≥100 × 10⁹/L; Hemoglobin ≥9.0 g/dL; Total bilirubin ≤1.5 × upper limit of normal (ULN) (or ≤3 × ULN in patients with Gilbert's syndrome); AST/ALT ≤2.5 × ULN; Creatinine clearance ≥50 mL/min (by Cockcroft-Gault or measured); * Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to enrollment and agree to use effective contraception during the study treatment period and for at least 3 months after the last study procedure. Men with partners of childbearing potential must agree to use effective contraception during the same period. * Willing and able to provide written informed consent and comply with all study procedures, including scheduled follow-up visits and blood sample collections. Exclusion Criteria: * Prior radiotherapy to the same anatomical site that would result in overlap of radiation fields. * Distant metastases at the time of enrollment (M1 disease). * Pregnancy or breastfeeding. * Active second malignancy requiring systemic therapy within the past 3 years, except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ. * Severe, active comorbidities including but not limited to: Uncontrolled infection requiring intravenous antibiotics; Decompensated heart failure (New York Heart Association Class III or IV); Myocardial infarction or unstable angina within 6 months; Severe chronic obstructive pulmonary disease or other conditions that would preclude safe radiotherapy or surgery. * Known hypersensitivity to radiation therapy procedures or inability to undergo required imaging (e.g., MRI contrast allergy not manageable with premedication). * Concurrent participation in another interventional clinical trial with an investigational agent within 30 days prior to enrollment. * Any condition that, in the opinion of the investigator, would compromise patient safety, interfere with study compliance, or preclude successful completion of the study procedures.

Locations (1)

2nd Affiliated Hospital, School of Medicine

Hangzhou, Zhejiang, China