Actively Recruiting
SFRT and SCART in Radiotherapy for Bone Metastases With Soft Tissue
Led by Shandong Cancer Hospital and Institute · Updated on 2025-07-08
90
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a randomized, controlled, prospective phase II, two-arm clinical study designed to evaluate the efficacy and safety of using either Spatially Fractionated Radiotherapy (SFRT) or Stereotactic Central Ablative Radiotherapy (SCART) for treating the soft tissue components of malignant bone metastases. The study plans to enroll 90 patients with bone metastases accompanied by soft tissue formation, who will be randomized in a 2:1 ratio to the SFRT/SCART group or the conventional radiotherapy (CRT) group.The primary endpoint is the objective response rate (ORR). Tumor response to treatment will be assessed every 12 weeks (±7 days) according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Secondary endpoints include pain relief rate, progression-free survival (PFS), and safety. In addition, adverse events (AEs) will be monitored throughout the study.
CONDITIONS
Official Title
SFRT and SCART in Radiotherapy for Bone Metastases With Soft Tissue
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent before any trial procedures
- Male or female aged 18 to 75 years
- Histopathologically confirmed single primary tumor (excluding small cell or undifferentiated carcinoma)
- ECOG performance status 0 to 2
- At least one bone metastasis with a soft tissue mass confirmed by CT or MRI, with shortest diameter over 30 mm
- No more than 5 metastatic lesions and no more than 3 metastatic organs
- Expected survival of at least 3 months
- Normal main organ functions within 14 days before enrollment, including specified blood counts and liver, kidney, and coagulation parameters
You will not qualify if you...
- Pathological fracture confirmed by CT or MRI
- Prior radiotherapy to the target lesion
- Pregnant or lactating women
- Acute infection or serious underlying diseases
- History of neurological or mental diseases affecting informed consent ability
- Any disease, treatment, or abnormal lab results that may interfere with study results or participation
- Other conditions deemed by the researcher to make participation unsafe or unsuitable
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shandong Cancer Hospital and Institute
Jinan, Shandong, China, 0531
Actively Recruiting
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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