Comparing two types of radiation therapy for 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 multicenter, prospective, randomized controlled clinical trial evaluates the efficacy and safety of Spatially Fractionated Radiation Therapy (SFRT) compared to Conventional Radiation Therapy (CRT) in treating soft tissue sarcoma (STS) with a minimum tumor diameter of 5 cm. A total of 106 patients will be enrolled and randomized into two groups, receiving either SFRT or CRT. The primary endpoint is the objective response rate of the target lesion at various time points post-treatment, while secondary endpoints include local control rate, progression-free survival, safety, and quality of life assessments. The study utilizes advanced radiation techniques to enhance tumor control and potentially stimulate immune responses.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 1\. Age 18-70 years, irrespective of gender. 2. Pathologically or clinically confirmed diagnosis of soft tissue sarcoma. 3. Minimum tumor diameter ≥5 cm. 4. Receiving systemic treatment as per multidisciplinary team (MDT) recommendations.

  5\. Measurable lesion (per RECIST 1.1/Choi criteria: longest diameter \>1.5 cm, or \>1 cm with two measurable perpendicular diameters).

  6\. ECOG performance status ≤2. 7. Expected survival ≥3 months. 8. Normal liver, kidney, lung, and cardiac function, with tolerance for treatment.

  9\. Patients of childbearing potential agree to use reliable contraception during treatment and for one year thereafter.

  10\. Voluntary provision of signed informed consent.

Exclusion Criteria:

* (1) Patients with a second primary malignancy. (2) Diagnosis of aggressive fibromatosis or rhabdomyosarcoma. (3) Prior radiotherapy to the target lesion. (4) Tumor unsuitable for radiotherapy. (5) Severe liver, kidney, lung, or cardiac dysfunction, precluding tolerance to systemic therapy or radiotherapy.

  (6) Other severe medical conditions that may impact the study (e.g., uncontrolled diabetes, gastric ulcers, or other serious cardiopulmonary diseases).

  (7) Severe or uncontrolled infections, or active autoimmune diseases. (8) Clinically evident central nervous system dysfunction. (9) Pregnant or lactating women, or women of childbearing potential not using contraception.

  (10) Other conditions deemed unsuitable for participation by the investigator.

Where it's running

• Shandong Cancer Hospital and Institute
  Jinan, Shandong, China Recruiting

Study contacts

• Principal investigator: Jinbo Yue, Doctor — Shandong Cancer Hospital and Institute
• Study coordinator: Jinbo Yue, Doctor
• Email: jbyue@sdfmu.edu.cn
• Phone: 0531-67626442

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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.