Status:
RECRUITING
SFRT and SCART in Radiotherapy for Bone Metastases With Soft Tissue
Lead Sponsor:
Shandong Cancer Hospital and Institute
Conditions:
Bone Metastases in Subjects With Advanced Cancer
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 C...
Detailed Description
Bone is a common site for tumor metastasis, with approximately 18.8 out of every 100,000 cancer patients diagnosed with bone metastases each year. Lung cancer, prostate cancer, and breast cancer are t...
Eligibility Criteria
Inclusion
- 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:
- The blood routine examination criteria should meet:
- Hemoglobin (HB) ≥ 90g/L;
- Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L;
- Platelet count (PLT) ≥ 75×10⁹/L;
- There is no functional organic disease, and the following criteria should be met:
- 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;
- 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);
- 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;
- International normalized ratio (INR) and activated partial thromboplastin time (APTT): ≤ 1.5×ULN;
Exclusion
- Pathological fracture confirmed by CT or MR.
- Prior radiotherapy to the target lesion.
- Pregnant or lactating women.
- Acute infection or other serious underlying diseases.
- Obvious history of neurological and mental diseases, including dementia that may affect the ability to understand and give informed consent.
- 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.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2027
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06987370
Start Date
June 1 2025
End Date
November 30 2027
Last Update
July 8 2025
Active Locations (1)
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1
Shandong Cancer Hospital and Institute
Jinan, Shandong, China, 0531