Condition: Bone Metastases in Subjects With Advanced Cancer · Sponsor: Shandong Cancer Hospital and Institute
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.
This description comes directly from the study's public registry record.
Jinbo Yue, Doctor · 0531-67626442 · jbyue@sdfmu.edu.cn
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| Shandong Cancer Hospital and Institute | Jinan, Shandong, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06987370