Bone Metastases in Subjects With Advanced CancerNCT06987370
SFRT and SCART in Radiotherapy for Bone Metastases With Soft Tissue
A study testing Conventional Radiotherapy (CRT) and SCART (Stereotactic Central Ablative Radiation Therapy ) /SFRT（Spatially Fractionated Radiation Therapy ） in people with Bone Metastases in Subjects With Advanced Cancer, run by Shandong Cancer Hospital and Institute at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bone Metastases in Subjects With Advanced Cancer
- What is being tested?
- Conventional Radiotherapy (CRT) and SCART (Stereotactic Central Ablative Radiation Therapy ) /SFRT（Spatially Fractionated Radiation Therapy ）
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 10Show fewer
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shandong Cancer Hospital and Institute
Jinan, Shandong, 0531
Jinbo Yue, doctor, 0531-67626442, jbyue@sdfmu.edu.cn
About this 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
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.
Read the 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 the most common primary tumor types leading to bone metastases. Currently, there is limited research on bone metastases accompanied by soft tissue formation. However, such formations have been observed in the majority of bone metastasis cases originating from solid tumors. Conventional radiotherapy regimens for bone metastases often show poor local control over the soft tissue component. Based on above undergrounds, this study is designed to be a random, controlled, prospective phase II, two-arm clinical study. Totally 90 patients with bone metastasis accompanied by soft issue formation will be enrolled and randomized in a 2:1 ratio to the Spatially Fractionated Radiotherapy (SFRT)/ Stereotactic Central Ablative Radiotherapy (SCART) group or the conventional radiotherapy (CRT) group with the primary endpoint being the objective response rate (ORR) of the target lesion at 3, 6, 9, and 12 months post-radiotherapy, assessed using RECIST 1.1. Secondary endpoints include pain relief rate, PFS and safety (per CTCAE v5.0). Eligibility criteria include patients aged 18-75 years, ECOG performance status ≤2, and an expected survival of ≥3 months. Those with secondary primary tumors, pathological fracture confirmed by CT or MRI, patients who received radiotherapy to the target lesion prior to enrollment or women who are pregnant or breastfeeding will be excluded. Comprehensive baseline assessments (imaging, pathology, laboratory tests) are conducted pretreatment, with weekly toxicity monitoring during treatment. Efficacy assessments consist of ORR of 3,6,9,12 months and tumor-related pain evaluation. During the course of radiotherapy, patient-reported pain is measured using the Numeric Rating Scale (NRS) every week. After the completion of radiotherapy, pain assessments are conducted every 6 weeks. Imaging evaluations are performed every 12 weeks after completion of radiotherapy and include high-resolution MRI, CT of bone metastatic sites. Statistical analysis assumes a one-sided α=0.05, β=0.8, anticipating an ORR of 90% for SFRT/SCART versus 66% for CRT. This study aims to evaluate the efficacy and safety of using either Spatially Fractionated Radiotherapy (SFRT) or Stereotactic Central Ablative Radiotherapy (SCART) for treating the bone metastases with soft tissue formation.
- Being tested
- Conventional Radiotherapy (CRT), SCART (Stereotactic Central Ablative Radiation Therapy ) /SFRT（Spatially Fractionated Radiation Therapy ）
- Keywords
- bone metastases, bone metastases with soft tissue, SFRT, SCART
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Radiotherapy (CRT)Radiation
Also called CRT group
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.
SCART (Stereotactic Central Ablative Radiation Therapy ) /SFRT（Spatially Fractionated Radiation Therapy ）Radiation
Also called SCART (Stereotactic Core Ablative Radiation Therapy ) /SFRT（Spatially Fractionated Radiation Therapy ）, SCART/SFRT group
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.
| Study group | Role | What they receive |
|---|---|---|
| SFRT/SCART GROUP | Experimental | 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 Radiotherapy (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. Receives: Radiation: SCART (Stereotactic Central Ablative Radiation Therapy ) /SFRT（Spatially Fractionated Radiation Therapy ） |
| Conventional Radiotherapy (CRT) Group | Active comparator | The conventional radiotherapy group, that is, the control group, delineated the target areas in accordance with the consensus guidelines on the definition of target volumes in spinal stereotactic radiosurgery by the International Spine Radiosurgery Consortium and other relevant guidelines according to the location of bone metastases, and administered conventional external beam radiotherapy with a dose of 30 Gy in 10 fractions to the bone metastasis lesions. Receives: Radiation: Conventional Radiotherapy (CRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Defined as the proportion of patients whose tumor size decreases (partial response) or disappears (complete response) after radiation based on RECIST 1.1. (CR, complete disappearance of the lesion) or partial response (PR, ≥30% reduction in lesion diameter sum) at 3, 6, 9, and 12 months post-radiotherapy, evaluated according to RECIST 1.1.
Measured: 1 year
Secondary outcomes (3)
The pain relief rate
The NRS score is used as an indicator of the treatment response. Complete remission is defined as the absence of pain three months after radiotherapy. Partial remission is defined as the pain score being at least 2 points lower than the initial score (or the daily dosage of narcotic drugs decreasing by more than 20%). The stable state is defined as the change in the pain score not exceeding 1 point (or the change in the daily dosage of narcotic drugs not exceeding 10%). A progressive response is defined as the pain score being at least 2 points higher than the initial score (or the daily dosage of narcotic drugs increasing by more than 20%).
Measured: 1 year
Local control rate
Local control rate is defined as the time from the start of radiotherapy to either progression of the target lesion (assessed per RECIST 1.1 criteria) or patient death from any cause, whichever occurs first.
Measured: 1 year
Adverse event incidence (Safety)
Treatment-related adverse events are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE 5.0).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start1 Jun 2025
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Bone Metastases in Subjects With Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study intends to recruit 90 patients with bone metastases with soft tissue formation and randomly assign them to the experimental group and the group in a ratio of 2:1. The experimental group will be treated with either Spatially Fractionated Radiotherapy (SFRT) or Stereotactic Central Adaptive Radiotherapy (SCART) for the bone metastatic lesions (8-12 Gy in 1 fraction for vertices/SCART- treatment volume in the soft tissue lesions followed by 25-40 Gy in 5 fractions for the whole bone metastatic lesions). The control group will receive conventional external radiotherapy with a dose of 30 Gy in 10 fractions.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinbo Yue, Shandong Cancer Hospital and Institute
- Investigators
- Jinbo Yue, Doctor, Principal investigator, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987370
- Sponsor's protocol ID
- SDZLEC2025-076-03
- Status last verified
- Oct 2026
- First submitted
- 16 May 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dunne EM, Sahgal A, Lo SS, Bergman A, Kosztyla R, Dea N, Chang EL, Chang UK, Chao ST, Faruqi S, Ghia AJ, Redmond KJ, Soltys SG, Liu MC. International consensus recommendations for target volume delineation specific to sacral metastases and spinal stereotactic body radiation therapy (SBRT). Radiother Oncol. 2020 Apr;145:21-29. doi: 10.1016/j.radonc.2019.11.026. Epub 2019 Dec 23.
PubMed 31874346Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
PubMed 19097774Nguyen TK, Chin L, Sahgal A, Dagan R, Eppinga W, Guckenberger M, Kim JH, Lo SS, Redmond KJ, Siva S, Stish BJ, Chan R, Lawrence L, Lau A, Tseng CL. International Multi-institutional Patterns of Contouring Practice and Clinical Target Volume Recommendations for Stereotactic Body Radiation Therapy for Non-Spine Bone Metastases. Int J Radiat Oncol Biol Phys. 2022 Feb 1;112(2):351-360. doi: 10.1016/j.ijrobp.2021.09.004. Epub 2021 Sep 9.
PubMed 34509549Cox BW, Spratt DE, Lovelock M, Bilsky MH, Lis E, Ryu S, Sheehan J, Gerszten PC, Chang E, Gibbs I, Soltys S, Sahgal A, Deasy J, Flickinger J, Quader M, Mindea S, Yamada Y. International Spine Radiosurgery Consortium consensus guidelines for target volume definition in spinal stereotactic radiosurgery. Int J Radiat Oncol Biol Phys. 2012 Aug 1;83(5):e597-605. doi: 10.1016/j.ijrobp.2012.03.009. Epub 2012 May 19.
PubMed 22608954Wu X, Perez NC, Zheng Y, Li X, Jiang L, Amendola BE, Xu B, Mayr NA, Lu JJ, Hatoum GF, Zhang H, Chang SX, Griffin RJ, Guha C. The Technical and Clinical Implementation of LATTICE Radiation Therapy (LRT). Radiat Res. 2020 Dec 1;194(6):737-746. doi: 10.1667/RADE-20-00066.1.
PubMed 33064814Yang J, Lu Q, Qi W, Kolb RD, Wang L, Li Y, Li S, Lin Y, Liu J, Mourad W, MirkhaghaniHaghighi F, Slavisa T, Wu X, You WC, Yang E, Hanlon A, Zhu A, Yan W. Stereotactic central/core ablative radiation therapy: results of a phase I study of a novel strategy to treat bulky tumor. Front Oncol. 2024 May 24;14:1364627. doi: 10.3389/fonc.2024.1364627. eCollection 2024.
PubMed 38854732Jung IH, Yoon SM, Kwak J, Park JH, Song SY, Lee SW, Ahn SD, Choi EK, Kim JH. High-dose radiotherapy is associated with better local control of bone metastasis from hepatocellular carcinoma. Oncotarget. 2017 Feb 28;8(9):15182-15192. doi: 10.18632/oncotarget.14858.
PubMed 28146433Kou Y, Xu K, Zhu K, Jiang S, Feng R, Dou X, Xu L, Zhang X, Shi F, Liu X, Gong Z, Yue J. Efficacy and safety evaluation of radiotherapy approach based on spatially fractionated radiotherapy and stereotactic core ablative radiation therapy technologies for bone metastatic malignant tumors with soft tissue formation: A randomized controlled phase II trial. Precis Radiat Oncol. 2025 Dec 19;9(4):260-265. doi: 10.1002/pro6.70036. eCollection 2025 Dec.
PubMed 41477287
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06987370
- Acronym / sponsor ID
- SDZLEC2025-076-03
- Keywords
- bone metastases, bone metastases with soft tissue, SFRT, SCART
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 23 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 the most common primary tumor types leading to bone metastases. Currently, there is limited research on bone metastases accompanied by soft tissue formation. However, such formations have been observed in the majority of bone metastasis cases originating from solid tumors. Conventional radiotherapy regimens for bone metastases often show poor local control over the soft tissue component. Based on above undergrounds, this study is designed to be a random, controlled, prospective phase II, two-arm clinical study. Totally 90 patients with bone metastasis accompanied by soft issue formation will be enrolled and randomized in a 2:1 ratio to the Spatially Fractionated Radiotherapy (SFRT)/ Stereotactic Central Ablative Radiotherapy (SCART) group or the conventional radiotherapy (CRT) group with the primary endpoint being the objective response rate (ORR) of the target lesion at 3, 6, 9, and 12 months post-radiotherapy, assessed using RECIST 1.1. Secondary endpoints include pain relief rate, PFS and safety (per CTCAE v5.0). Eligibility criteria include patients aged 18-75 years, ECOG performance status ≤2, and an expected survival of ≥3 months. Those with secondary primary tumors, pathological fracture confirmed by CT or MRI, patients who received radiotherapy to the target lesion prior to enrollment or women who are pregnant or breastfeeding will be excluded. Comprehensive baseline assessments (imaging, pathology, laboratory tests) are conducted pretreatment, with weekly toxicity monitoring during treatment. Efficacy assessments consist of ORR of 3,6,9,12 months and tumor-related pain evaluation. During the course of radiotherapy, patient-reported pain is measured using the Numeric Rating Scale (NRS) every week. After the completion of radiotherapy, pain assessments are conducted every 6 weeks. Imaging evaluations are performed every 12 weeks after completion of radiotherapy and include high-resolution MRI, CT of bone metastatic sites. Statistical analysis assumes a one-sided α=0.05, β=0.8, anticipating an ORR of 90% for SFRT/SCART versus 66% for CRT. This study aims to evaluate the efficacy and safety of using either Spatially Fractionated Radiotherapy (SFRT) or Stereotactic Central Ablative Radiotherapy (SCART) for treating the bone metastases with soft tissue formation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study intends to recruit 90 patients with bone metastases with soft tissue formation and randomly assign them to the experimental group and the group in a ratio of 2:1. The experimental group will be treated with either Spatially Fractionated Radiotherapy (SFRT) or Stereotactic Central Adaptive Radiotherapy (SCART) for the bone metastatic lesions (8-12 Gy in 1 fraction for vertices/SCART- treatment volume in the soft tissue lesions followed by 25-40 Gy in 5 fractions for the whole bone metastatic lesions). The control group will receive conventional external radiotherapy with a dose of 30 Gy in 10 fractions.
| Arm | Type | Receives |
|---|---|---|
| SFRT/SCART GROUP | Experimental | 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 Radiotherapy (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. |
| Conventional Radiotherapy (CRT) Group | Active comparator | Radiation: Conventional Radiotherapy (CRT)The conventional radiotherapy group, that is, the control group, delineated the target areas in accordance with the consensus guidelines on the definition of target volumes in spinal stereotactic radiosurgery by the International Spine Radiosurgery Consortium and other relevant guidelines according to the location of bone metastases, and administered conventional external beam radiotherapy with a dose of 30 Gy in 10 fractions to the bone metastasis lesions. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- There is no functional organic disease, and the following criteria should be met:
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional Radiotherapy (CRT)Also: CRT groupThe 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 | Conventional Radiotherapy (CRT) Group |
| SCART (Stereotactic Central Ablative Radiation Therapy ) /SFRT（Spatially Fractionated Radiation Therapy ）Also: SCART (Stereotactic Core Ablative Radiation Therapy ) /SFRT（Spatially Fractionated Radiation Therapy ）, SCART/SFRT groupStereotactic 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. | Radiation | SFRT/SCART GROUP |
Primary outcome
Objective response rate (ORR)
Time frame: 1 year
Defined as the proportion of patients whose tumor size decreases (partial response) or disappears (complete response) after radiation based on RECIST 1.1. (CR, complete disappearance of the lesion) or partial response (PR, ≥30% reduction in lesion diameter sum) at 3, 6, 9, and 12 months post-radiotherapy, evaluated according to RECIST 1.1.
3 secondary outcomes
The pain relief rate
Time frame: 1 year
Local control rate
Time frame: 1 year
Adverse event incidence (Safety)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Background: PubMed 31874346Dunne EM, Sahgal A, Lo SS, Bergman A, Kosztyla R, Dea N, Chang EL, Chang UK, Chao ST, Faruqi S, Ghia AJ, Redmond KJ, Soltys SG, Liu MC. International consensus recommendations for target volume delineation specific to sacral metastases and spinal stereotactic body radiation therapy (SBRT). Radiother Oncol. 2020 Apr;145:21-29. doi: 10.1016/j.radonc.2019.11.026. Epub 2019 Dec 23.
- Background: PubMed 19097774Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
- Background: PubMed 34509549Nguyen TK, Chin L, Sahgal A, Dagan R, Eppinga W, Guckenberger M, Kim JH, Lo SS, Redmond KJ, Siva S, Stish BJ, Chan R, Lawrence L, Lau A, Tseng CL. International Multi-institutional Patterns of Contouring Practice and Clinical Target Volume Recommendations for Stereotactic Body Radiation Therapy for Non-Spine Bone Metastases. Int J Radiat Oncol Biol Phys. 2022 Feb 1;112(2):351-360. doi: 10.1016/j.ijrobp.2021.09.004. Epub 2021 Sep 9.
- Background: PubMed 22608954Cox BW, Spratt DE, Lovelock M, Bilsky MH, Lis E, Ryu S, Sheehan J, Gerszten PC, Chang E, Gibbs I, Soltys S, Sahgal A, Deasy J, Flickinger J, Quader M, Mindea S, Yamada Y. International Spine Radiosurgery Consortium consensus guidelines for target volume definition in spinal stereotactic radiosurgery. Int J Radiat Oncol Biol Phys. 2012 Aug 1;83(5):e597-605. doi: 10.1016/j.ijrobp.2012.03.009. Epub 2012 May 19.
- Background: PubMed 33064814Wu X, Perez NC, Zheng Y, Li X, Jiang L, Amendola BE, Xu B, Mayr NA, Lu JJ, Hatoum GF, Zhang H, Chang SX, Griffin RJ, Guha C. The Technical and Clinical Implementation of LATTICE Radiation Therapy (LRT). Radiat Res. 2020 Dec 1;194(6):737-746. doi: 10.1667/RADE-20-00066.1.
- Background: PubMed 38854732Yang J, Lu Q, Qi W, Kolb RD, Wang L, Li Y, Li S, Lin Y, Liu J, Mourad W, MirkhaghaniHaghighi F, Slavisa T, Wu X, You WC, Yang E, Hanlon A, Zhu A, Yan W. Stereotactic central/core ablative radiation therapy: results of a phase I study of a novel strategy to treat bulky tumor. Front Oncol. 2024 May 24;14:1364627. doi: 10.3389/fonc.2024.1364627. eCollection 2024.
- Background: PubMed 28146433Jung IH, Yoon SM, Kwak J, Park JH, Song SY, Lee SW, Ahn SD, Choi EK, Kim JH. High-dose radiotherapy is associated with better local control of bone metastasis from hepatocellular carcinoma. Oncotarget. 2017 Feb 28;8(9):15182-15192. doi: 10.18632/oncotarget.14858.
- Derived from this study: PubMed 41477287Kou Y, Xu K, Zhu K, Jiang S, Feng R, Dou X, Xu L, Zhang X, Shi F, Liu X, Gong Z, Yue J. Efficacy and safety evaluation of radiotherapy approach based on spatially fractionated radiotherapy and stereotactic core ablative radiation therapy technologies for bone metastatic malignant tumors with soft tissue formation: A randomized controlled phase II trial. Precis Radiat Oncol. 2025 Dec 19;9(4):260-265. doi: 10.1002/pro6.70036. eCollection 2025 Dec.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jinbo Yue, Doctor principal investigator
Shandong Cancer Hospital and Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Radiotherapy (CRT) and SCART (Stereotactic Central Ablative Radiation Therapy ) /SFRT（Spatially Fractionated Radiation Therapy ） in people with Bone Metastases in Subjects With Advanced Cancer, run by Shandong Cancer Hospital and Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jinbo Yue, Doctor (0531-67626442, jbyue@sdfmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06987370, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.