At a glance
ClinicalIndex Comparison Record- ✓Male or female, aged 18-75 years
- ✓Histopathologically confirmed single primary tumor
- ✓At least one target lesion: bone metastasis with soft tissue mass confirmed by CT or MRI, shortest diameter >30mm
- ✓≤5 metastatic lesions and ≤3 metastatic organs
- ✕Pathological fracture confirmed by CT or MR
- ✕Prior radiotherapy to the target lesion
- ✕Pregnant or lactating women
- ✕Acute infection or other serious underlying diseases
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Randomized Controlled Clinical Study on the Efficacy and Safety Evaluation of Radiotherapy Mode Based on SFRT and SCART Technologies for Bone Metastatic Malignant Tumors With Soft Tissue Formation
In Brief
A clinical study evaluating Conventional Radiotherapy (CRT) and SCART (Stereotactic Central Ablative Radiation Therapy ) /SFRT（Spatially Fractionated Radiation Therapy ） for Bone Metastases in Subjects With Advanced Cancer. Currently recruiting, targeting 90 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
The conventional radiotherapy group, that is, the control group, administering conventional external beam radiotherapy with a dose of 30 Gy in 10 fractions to the bone metastasis lesions.
Stereotactic Central Ablative Radiotherapy (SCART): When using SCART to treat bone metastases with associated soft tissue components, the gross tumor volume (GTV) of the bone metastases must be accurately delineated according to the guidelines. The GTV are contracted to derive the SCART-Treatment Volume (STV). An initial dose of 8-12 Gy in a single fraction is delivered to the STV, followed by a dose of 25-40 Gy in 5 fractions to the clinical target volume (CTV). Spatially Fractionated Radiation Therapy (SFRT): The GTV are reduced to form a "LATTICE" target area. Several vertices are uniformly contoured along the edges of the "LATTICE." A dose of 8-12 Gy in a single fraction is delivered to the vertices, followed by a dose of 25-40 Gy in 5 fractions to the CTV.