SFRT and SCART in Radiotherapy for Bone Metastases With Soft Tissue

NCT06987370 · tracked via the Priya Life Science China tracker

Sponsor

Shandong Cancer Hospital and Institute

Phase

Not applicable

Started

2025-06-01

Last updated

2026-10-13

Condition(s) studied

Bone Metastases in Subjects With Advanced Cancer

Investigational drug(s) / intervention(s)

Conventional Radiotherapy (CRT)SCART (Stereotactic Central Ablative Radiation Therapy ) /SFRT（Spatially Fractionated Radiation Therapy ）

Conventional Radiotherapy (CRT): 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.

SCART (Stereotactic Central Ablative Radiation Therapy ) /SFRT（Spatially Fractionated Radiation Therapy ）: 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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: 1\. Sign a written informed consent form before implementing any trial-related procedures; 2. Male or female, aged 18 years or above and 75 years or below; 3. Have a histopathologically confirmed single primary tumor (patients with a pathological diagnosis of small cell carcinoma or undifferentiated carcinoma are excluded); 4. ECOG PS 0-2; 5. Have at least one target lesion: bone metastasis with a soft tissue mass confirmed by CT or MRI. The shortest diameter of the soft tissue is greater than 30mm; 6. The number of metastatic lesions is ≤ 5 and the number of metastatic organs is ≤ 3; 7. The expected survival time is ≥ 3 months; 8. The main organ functions are normal (within 14 days before enrollment), that is, the following criteria are met: 1. The blood routine examination criteria should meet: 1. Hemoglobin (HB) ≥ 90g/L; 2. Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L; 3. Platelet count (PLT) ≥ 75×10⁹/L; 2. There is no functional organic disease, and the following criteria should be met: 1. 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; 2. 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); 3. 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; 4. International normalized ratio (INR) and activated partial thromboplastin time (APTT): ≤ 1.5×ULN; Exclusion Criteria: 1. Pathological fracture confirmed by CT or MR. 2. Prior radiotherapy to the target lesion. 3. Pregnant or lactating women. 4. Acute infection or other serious underlying diseases. 5. Obvious history of neurological and mental diseases, including dementia that may affect the ability to understand and give informed consent. 6. 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.

Primary outcome measure(s)

Objective response rate (ORR) — 1 year
Defined as the proportion of patients whose tumor size decreases (partial response) or disappears (complete response) after radiation based on RECIST 1.1. (CR, complete disappearance of the lesion) or partial response (PR, ≥30% reduction in lesion diameter sum) at 3, 6, 9, and 12 months post-radiotherapy, evaluated according to RECIST 1.1.

Trial sites (1)

Facility	City	Region	Status
Shandong Cancer Hospital and Institute	Jinan	Shandong	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06987370 on ClinicalTrials.gov ↗ ← All trials in China