SFRT and SCART in Radiotherapy for Bone Metastases With Soft Tissue (NCT06987370) | Clinical Trial Compass
RecruitingNot Applicable
SFRT and SCART in Radiotherapy for Bone Metastases With Soft Tissue
China90 participantsStarted 2025-06-01
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. The blood routine examination criteria should meet:
✓. Hemoglobin (HB) ≥ 90g/L;
✓. Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L;
✓. Platelet count (PLT) ≥ 75×10⁹/L;
✓. There is no functional organic disease, and the following criteria should be met:
✓. When there is no liver metastasis, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5× ULN, serum total bilirubin ≤ 1.5× ULN, alkaline phosphatase (ALP) ≤ 3× ULN; when there is liver metastasis, ALT and AST ≤ 5× ULN, serum total bilirubin ≤ 3× ULN, and alkaline phosphatase (ALP) ≤ 5× ULN;
✓. Serum creatinine level Cr ≤ 1.5×ULN (if the serum creatinine is elevated, a 24-hour urine collection is required, except for those with a 24-hour creatinine clearance rate \> 50ml/min);
✓. Urine protein \< 2+. If the test strip result is ≥ 2+, the 24-hour urine protein must be \< 2g, or the urine protein-to-creatinine ratio (UPC) must be \< 2;
✕. Acute infection or other serious underlying diseases.
✕. Obvious history of neurological and mental diseases, including dementia that may affect the ability to understand and give informed consent.
✕. History or evidence of diseases, treatments or abnormal laboratory test values that may interfere with the test results and prevent the subject from participating in the study throughout the whole process, or other situations that the researcher deems inappropriate for enrollment. The researcher believes that there are other potential risks that make the subject unsuitable for participating in this study.