SFRT and SCART in Radiotherapy for Bone Metastases With Soft Tissue

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.

NCT Number	NCT06987370
Lead Sponsor	Shandong Cancer Hospital and Institute
Conditions	Bone Metastases in Subjects With Advanced Cancer
Enrollment	90 participants
Start Date	2025-06-01
Primary Completion	2027-11-30 (estimated)
Study Completion	2027-11-30 (estimated)
Updated on ClinicalTrials.gov	2025-07-08