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New treatment option for Bone Metastases in Subjects With Advanced Cancer
Official title SFRT and SCART in Radiotherapy for Bone Metastases With Soft Tissue
ClinicalTrials.gov ID: NCT06987370
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- 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;
You likely can't join if
- 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...
See the full eligibility 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...
- 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...
- 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;
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jinan, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.