Targeted radiotherapy (SFRT or SCART) for bone metastases with soft-tissue tumors

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

This study will test whether two advanced radiation methods (SFRT or SCART) shrink the soft-tissue part of bone metastases better than conventional radiotherapy in adults with advanced cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shandong Cancer Hospital and Institute (Academic / other)
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT06987370 on ClinicalTrials.gov

What this trial studies

This is a randomized, controlled, prospective phase II, two-arm study enrolling 90 patients who have bone metastases with a soft-tissue mass and randomizing them 2:1 to SFRT/SCART versus conventional radiotherapy. The primary endpoint is objective response rate (ORR) of the target lesion measured by RECIST 1.1 at 3, 6, 9, and 12 months after radiotherapy. Secondary endpoints include pain relief rate, progression-free survival (PFS), and safety with adverse events monitored throughout per CTCAE v5.0. Key eligibility includes age 18–75, ECOG 0–2, a soft-tissue lesion diameter >30 mm, ≤5 metastatic lesions in ≤3 organs, expected survival ≥3 months, and no prior radiotherapy to the target lesion.

Who should consider this trial

Good fit: Adults 18–75 years with advanced cancer and a bone metastasis that includes a soft-tissue mass (>30 mm), ECOG performance status 0–2, ≤5 metastatic lesions in ≤3 organs, expected survival ≥3 months, and no prior radiotherapy to the target lesion.

Not a fit: Patients with pathological fracture at the target site, small cell or undifferentiated primary tumors, prior radiotherapy to the target lesion, very widespread metastatic disease, poor performance status, or very limited life expectancy are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, these techniques could improve local tumor shrinkage of soft-tissue components, relieve pain, and prolong time without local progression compared with conventional radiotherapy.

How similar studies have performed: Related spatially fractionated and stereotactic radiation approaches have shown promising results in small series, but randomized data specifically for bone metastases with soft-tissue components remain limited.

Eligibility criteria

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.

Where this trial is running

Jinan, Shandong

• Shandong Cancer Hospital and Institute — Jinan, Shandong, China (Recruiting)

Study contacts

• Principal investigator: Jinbo Yue, Doctor — Shandong Cancer Hospital and Institute
• Study coordinator: Jinbo Yue, Doctor

Conditions Bone Metastases in Subjects With Advanced Cancer; bone metastases; bone metastases with soft tissue; SFRT; SCART