Preoperative spatially fractionated radiation for large limb and trunk soft tissue sarcoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-arm phase II study that delivers spatially fractionated radiation therapy (SFRT) to the primary tumor in five fractions, followed by definitive surgery for operable or borderline-resectable soft tissue sarcoma of the limb or trunk. The primary endpoint is 1-year disease-free survival (DFS), with secondary endpoints including pathologic complete response (pCR) rate, overall survival (OS), safety, and immune correlates from peripheral samples. The protocol targets bulky tumors (≥5 cm) that are at higher risk of radioresistance and local recurrence, using SFRT’s non-uniform dosing to create high-dose peaks and low-dose valleys within the tumor. The study is conducted at the Second Affiliated Hospital, School of Medicine, Zhejiang University with multidisciplinary tumor-board selection and standard surgical follow-up.

Why it matters

Who can join: the full rules

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.

Where it's running

• 2nd Affiliated Hospital, School of Medicine
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Ting Zhang, phD.
• Email: zezht@zju.edu.cn
• Phone: +86-571-87783521

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.