Precision radiation takes aim at the soft tissue side of bone metastases
NCT ID NCT06987370
First seen Oct 13, 2026 · Last updated Oct 14, 2026 · Updated 1 time
Summary
Researchers are testing whether two specialized radiation techniques, SFRT and SCART, shrink the soft tissue part of bone metastases better than conventional radiotherapy. The trial enrolls 90 adults with advanced cancer whose bone metastases include a soft tissue mass. Participants are assigned in a 2 to 1 ratio to the specialized radiation group or the standard radiotherapy group. The main measure is how much the tumor shrinks, with pain relief and safety also tracked.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- two specialized radiation techniques, spatially fractionated radiotherapy (SFRT) and stereotactic central ablative radiotherapy (SCART)
- What this could lead to
- If SFRT or SCART shrinks the soft tissue part of bone metastases better than standard radiation, it could offer patients stronger tumor control and pain relief from a treatment course.
- What could go wrong
- This is a mid-stage trial with 90 patients at one cancer center, so results may not hold in a larger or more varied group. Radiation to bone metastases can damage nearby tissue, and the specialized techniques may not outperform standard radiotherapy.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shandong Cancer Hospital and Institute
RECRUITINGJinan, Shandong, 0531, China
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