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NCT06987370

SFRT and SCART in Radiotherapy for Bone Metastases With Soft Tissue

Sponsor: Shandong Cancer Hospital and Institute

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-06-01

Completion Date

2027-11-30

Last Updated

2025-07-08

Healthy Volunteers

Conditions

Bone Metastases in Subjects With Advanced Cancer

Interventions

RADIATION

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.

RADIATION

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.

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.

Locations (1)

Shandong Cancer Hospital and Institute

Jinan, Shandong, China