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

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

Trial Details

NCT ID
NCT06980259
Phase
NA
Sponsor
Shandong Cancer Hospital and Institute
Status
RECRUITING
Cancer Type
Sarcoma
Interventions
  • Spatially Fractionated Radiotherapy
  • Conventional Radiotherapy
Locations (sample)
  • Jinan, Shandong, China|36.66833,116.99722

Key Eligibility Criteria

  • 1\. Age 18-70 years, irrespective of gender. 2. Pathologically or clinically confirmed diagnosis of soft tissue sarcoma. 3. Minimum tumor diameter …
  • 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.

For full eligibility, visit ClinicalTrials.gov.

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