Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT06980259

Spatially Fractionated Radiotherapy Versus Conventional Radiotherapy in the Treatment of Soft Tissue Sarcoma

Led by Shandong Cancer Hospital and Institute · Updated on 2026-04-28

106

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is a multicenter, prospective, randomized controlled phase II clinical trial designed to evaluate the efficacy and safety of Spatially Fractionated Radiation Therapy (SFRT) compared to Conventional Radiation Therapy (CRT) in the treatment of soft tissue sarcoma (STS, minimum tumor diameter ≥5 cm). A total of 106 patients were enrolled and randomized in a 1:1 ratio. The primary endpoint is the objective response rate (ORR) of the target lesion at 3, 6, 9, and 12 months post-radiotherapy, assessed using RECIST 1.1 and Choi criteria. Secondary endpoints include the 1-year local control rate (LC) of the target lesion, progression-free survival (PFS), safety (per CTCAE v5.0), and quality of life (QoL, assessed by EORTC QLQ-C30). CRT is delivered at 3.0 Gy per fraction for a total of 15-20 fractions. SFRT comprises CRT at 3.0 Gy per fraction for 15-20 fractions, augmented by weekly high-dose vertices of 8-15 Gy per fraction for 3-4 fractions, aiming to enhance tumor control and potentially stimulate immune responses. This study is a multicenter, prospective, randomized controlled phase II clinical trial designed to evaluate the efficacy and safety of Spatially Fractionated Radiation Therapy (SFRT) compared to Conventional Radiation Therapy (CRT) in the treatment of soft tissue sarcoma (STS, minimum tumor diameter ≥5 cm). A total of 106 patients were enrolled and randomized in a 1:1 ratio. The primary endpoint is the objective response rate (ORR) of the target lesion at 3, 6, 9, and 12 months post-radiotherapy, assessed using RECIST 1.1 and Choi criteria. Secondary endpoints include the 1-year local control rate (LC) of the target lesion, progression-free survival (PFS), safety (per CTCAE v5.0). CRT is delivered at 3.0 Gy per fraction for a total of 15-20 fractions. SFRT comprises CRT at 3.0 Gy per fraction for 15-20 fractions, augmented by weekly high-dose vertices of 8-15 Gy per fraction for 3-4 fractions, aiming to enhance tumor control and potentially stimulate immune responses.

CONDITIONS

Official Title

Spatially Fractionated Radiotherapy Versus Conventional Radiotherapy in the Treatment of Soft Tissue Sarcoma

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18-70 years, any gender
  • Diagnosed with soft tissue sarcoma
  • Tumor diameter at least 5 cm
  • Receiving systemic treatment recommended by a multidisciplinary team
  • Measurable lesion per RECIST 1.1 or Choi criteria
  • ECOG performance status 0, 1, or 2
  • Expected to live at least 3 months
  • Normal liver, kidney, lung, and heart function, able to tolerate treatment
  • If able to have children, agree to use reliable contraception during treatment and for one year after
  • Voluntarily provide signed informed consent
Not Eligible

You will not qualify if you...

  • Having a second primary cancer
  • Diagnosed with aggressive fibromatosis or rhabdomyosarcoma
  • Previously received radiotherapy on the target lesion
  • Tumor not suitable for radiotherapy
  • Severe liver, kidney, lung, or heart problems preventing treatment
  • Other serious medical conditions like uncontrolled diabetes or serious heart/lung diseases
  • Severe or uncontrolled infections or active autoimmune diseases
  • Central nervous system dysfunction
  • Pregnant or breastfeeding women, or women not using contraception if able to have children
  • Other conditions that the investigator deems unsuitable for participation

AI-Screening

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Trial Site Locations

Total: 1 location

1

Shandong Cancer Hospital and Institute

Jinan, Shandong, China, 0531

Actively Recruiting

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Research Team

J

Jinbo Yue, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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