Spinal MetastasesNCT06756087
Evaluate the Efficacy of Radiofrequency Ablation/Vertebroplasty with or Without SBRT for Treating Painful Spinal Vertebral Metastases
A study testing Radiofrequency Ablation (RFA)/Vertebroplasty+Stereotactic Radiotherapy and Experimental in people with Spinal Metastases and Local Control, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This study is a prospective, multicenter, open, practical, randomized controlled, non inferiority effect clinical study initiated by researchers, which aims to evaluate the clinical efficacy and safety of radiofrequency ablation/vertebroplasty and radiofrequency ablation/vertebroplasty combined with SBRT in the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Metastases, Local Control, Pain Cancer
- What is being tested?
- Radiofrequency Ablation (RFA)/Vertebroplasty+Stereotactic Radiotherapy and Experimental
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 31 Dec 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject voluntarily participates in this study, and both the patient and their family sign an informed consent form. The subject demonstrates good compliance and cooperates with follow-up.
- Age 18 or older, no gender restrictions.
- The target population for this trial consists of patients with bone metastases from malignant tumors confirmed by pathology or imaging, with lesions located between T5 and L5. The number of affected vertebral sites is fewer than three, and the lesions are mainly osteolytic, affecting primarily the vertebral bodies.
- Expected survival is greater than three months.
- Initial diagnosis with an NPRS pain score > 3.
- ECOG performance status score of 0-2.
- The function of vital organs meets the following requirements: a) Adequate bone marrow function: WBC ≥ 3.0×10^9/L; absolute neutrophil count (ANC) ≥ 1.5 ×10^9/L; lymphocyte count ≥ 6.0×10^8/L; platelet count ≥ 50×10^9/L, with no blood transfusion within 14 days prior to the first cellular therapy; hemoglobin ≥ 10.0 g/dL. b) Adequate liver and kidney function: total bilirubin ≤ 2.0×ULN, AST and ALT < 2.5×ULN; serum creatinine ≤ 1.5×ULN, or creatinine clearance ≥ 50 ml/min (calculated using the Cockcroft-Gault formula). c) Coagulation function: INR ≤ 1.5×ULN, APTT ≤ 1.5×ULN. d) Adequate cardiovascular function: left ventricular ejection fraction (EF) ≥ 50%, QTcF interval ≤ 450 ms for males and ≤ 470 ms for females.
- Use of at least one medically approved contraceptive method (e.g., surgical sterilization, oral contraceptives, intrauterine device, abstinence, or barrier methods with spermicide) for at least six months.
Who cannot join
- Subjects with no measurable lesions;
- Known brain metastasis and/or clinically suspected brain metastasis (subjects with asymptomatic brain metastasis or clinically stable brain metastasis for more than three months after local treatment can be included);
- Subjects whose target lesions received radiotherapy within the past two years;
- Tumor types sensitive to radiotherapy, including malignant lymphoma, testicular seminoma, Wilms tumor, neuroblastoma, medulloblastoma, Ewing sarcoma, and small cell tumors.
- Spinal metastases involving spinal appendages, destruction of the posterior wall of the vertebral canal, or compression of the spinal dura mater;
- Subjects preparing for or who have previously undergone tissue/organ transplantation;
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- Subjects with active infections or unexplained fever >38.5℃ during screening or before treatment;
- Patients with active pulmonary tuberculosis (TB), currently receiving anti-TB treatment or treated for TB within the past year before screening;
- Positive syphilis serology test;
- Known history of HIV-positive test or known acquired immunodeficiency syndrome (AIDS);
- Active hepatitis B: hepatitis B surface antigen (HBsAg) positive with HBV DNA levels exceeding 10,000 IU/ml; hepatitis C: hepatitis C antibody (HCV Ab) positive with HCV RNA levels exceeding 1,000 IU/ml; co-infection with hepatitis B and hepatitis C;
- Cardiovascular disease meeting any of the following: a. Congestive heart failure with NYHA classification ≥ III; b. Severe arrhythmia requiring medication; c. Acute myocardial infarction, severe or unstable angina, coronary or peripheral artery bypass grafting, or stenting within six months before initial dosing; d. Left ventricular ejection fraction (LVEF) < 50%; e. QTcF interval > 450 ms for males and > 470 ms for females, or risk factors for torsades de pointes, such as clinically significant hypokalemia, family history of long QT syndrome, or familial arrhythmias (e.g., Wolff-Parkinson-White syndrome) as determined by the investigator;
- Uncontrolled hypertension (defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg despite standardized antihypertensive treatment);
- Subjects deemed by the investigator to have serious uncontrolled diseases or other conditions that may affect participation in the study or render them unsuitable for study treatment.
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
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200092
Jing Ren, M.D., sfph_edu2@163.com
About this study
Official title: Radiofrequency Ablation/Vertebroplasty Versus Radiofrequency Ablation/Vertebroplasty Combined with SBRT for Painful Spinal Vertebral Metastases: a Multicenter, Practical, Randomized, Controlled, Non-Inferiority Clinical Study
This study is a prospective, multicenter, open, practical, randomized controlled, non inferiority effect clinical study initiated by researchers, which aims to evaluate the clinical efficacy and safety of radiofrequency ablation/vertebroplasty and radiofrequency ablation/vertebroplasty combined with SBRT in the treatment of painful spinal metastases. This study plans to include about 120 cases in about 3 research centers nationwide, including the Department of bone oncology of Shanghai First People's Hospital (main center, 60 cases), the Department of bone oncology of the Third Affiliated Hospital of Southern Medical University (sub center 1, 30 cases), and the Department of bone oncology of Peking University People's Hospital (sub center 2, 30 cases). The patient was diagnosed with spinal metastasis of malignant tumor and had pain of more than 3 points. The subjects with spinal metastasis located at t5-l5 were selected for clinical research. All patients were treated with RFA/PVA minimally invasive surgery. In principle, no more than 2 vertebral bodies were treated. All patients will receive MRI/CT examination of the affected spine within 6 weeks before enrollment to determine the degree of spinal involvement. All patients were randomly divided into experimental group and control group after minimally invasive surgery, the ratio was 1:1. The patients in the experimental group recovered to the original system treatment about two weeks after minimally invasive surgery; The control group began to receive SBRT radiotherapy of the surgical vertebral body in about two weeks, and the radiotherapy time was two weeks. According to the recommendations of the Department of radiotherapy, SBRT radiotherapy should use any of the following dose and grading scheme: 4 times 24gy, 5 times 30Gy, 6 times 36Gy, 7 times 42GY. The patients in the two groups were followed up after treatment, and evaluated at 1, 2 and 4 weeks and 3, 6 and 12 months after treatment. The NRPS pain degree and pafi pain function comprehensive score were evaluated, and the local lesions were evaluated at 1, 3, 6 and 12 months after operation. To evaluate the local control of spinal metastases, pain improvement and quality of life changes of the two treatment strategies.
Read the detailed description
This study is a prospective, multicenter, open, practical, randomized controlled, non inferiority effect clinical study initiated by researchers, which aims to evaluate the clinical efficacy and safety of radiofrequency ablation/vertebroplasty and radiofrequency ablation/vertebroplasty combined with SBRT in the treatment of painful spinal metastases. This study plans to include about 120 cases in about 3 research centers nationwide, including the Department of bone oncology of Shanghai First People's Hospital (main center, 60 cases), the Department of bone oncology of the Third Affiliated Hospital of Southern Medical University (sub center 1, 30 cases), and the Department of bone oncology of Peking University People's Hospital (sub center 2, 30 cases). The patient was diagnosed with spinal metastasis of malignant tumor and had pain of more than 3 points. The subjects with spinal metastasis located at t5-l5 were selected for clinical research. All patients were treated with RFA/PVA minimally invasive surgery. In principle, no more than 2 vertebral bodies were treated. All patients will receive MRI/CT examination of the affected spine within 6 weeks before enrollment to determine the degree of spinal involvement. All patients were randomly divided into experimental group and control group after minimally invasive surgery, the ratio was 1:1. The patients in the experimental group recovered to the original system treatment about two weeks after minimally invasive surgery; The control group began to receive SBRT radiotherapy of the surgical vertebral body in about two weeks, and the radiotherapy time was two weeks. According to the recommendations of the Department of radiotherapy, SBRT radiotherapy should use any of the following dose and grading scheme: 4 times 24gy, 5 times 30Gy, 6 times 36Gy, 7 times 42GY. The patients in the two groups were followed up after treatment, and evaluated at 1, 2 and 4 weeks and 3, 6 and 12 months after treatment. The NRPS pain degree and pafi pain function comprehensive score were evaluated, and the local lesions were evaluated at 1, 3, 6 and 12 months after operation. To evaluate the local control of spinal metastases, pain improvement and quality of life changes of the two treatment strategies.
- Conditions
- Spinal Metastases, Local Control, Pain Cancer
- Being tested
- Radiofrequency Ablation (RFA)/Vertebroplasty+Stereotactic Radiotherapy, Experimental
- Keywords
- spinal metastases, Radiofrequency Ablation, Stereotactic radiotherapy
- Medical subject headings
- Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency Ablation (RFA)/Vertebroplasty+Stereotactic RadiotherapyRadiation
All patients received OsteoCool™ radiofrequency ablation + vertebroplasty for spinal metastatic tumors at the Department of Bone Oncology, Shanghai First People's Hospital.
Standard Control Group: Patients received SBRT (Stereotactic Body Radiation Therapy) from the Department of Radiation Oncology 2-3 weeks post-surgery. This included pre-radiation positioning, mold preparation, and radiation therapy. After radiation therapy, patients rested for 2 weeks before resuming their original anti-tumor treatment and starting follow-up.SBRT therapy was administered according to the recommendations, using one of the following dose and fractionation schemes: 4 sessions of 24 Gy, 5 sessions of 30 Gy, 6 sessions of 36 Gy, or 7 sessions of 42 Gy.
ExperimentalProcedure or surgery
patients received OsteoCool™ radiofrequency ablation+vertebroplasty for spinal metastatic tumors at the Department of Bone Oncology, Shanghai First People's Hospital. patients continued their original anti-tumor treatment within 1-2 weeks based on their recovery. No further local intervention was performed at the surgical site, and normal follow-up was started.
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency ablation/vertebroplasty | Experimental | Patients underwent OsteoCool radiofrequency ablation and vertebroplasty for spinal metastatic tumors. After the operation, the original anti-tumor treatment was continued within 1-2 weeks according to the recovery. Local intervention was no longer carried out at the operation site, and the normal follow-up was started. Receives: Radiation: Radiofrequency Ablation (RFA)/Vertebroplasty+Stereotactic Radiotherapy |
| Standard control: Ablation/Vertebroplasty and SBRT Radiotherapy | Other | Patients underwent OsteoCool radiofrequency ablation and vertebroplastyfor spinal metastatic tumors. Then were sent to SBRT radiotherapy 2-3 weeks postoperatively. follow-up visit start at the end of adiotherapy. Receives: Procedure: Experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the pain control of RFA/PVA and RFA/PVA combined with SBRT radiotherapy for painful spinal metastases.
Based on NRPS pain score: Compare the pain scores of two groups of patients at 1, 2, and 4 weeks after treatment, as well as at 3, 6, and 12 months after treatment.
The Numerical Pain Rating (NPR) Scale is used to assess the intensity of a patient's pain. The pain intensity is rated using numbers from 0 to 10, where 0 represents no pain, and 10 represents the most intense pain imaginable. The patient is asked to select a number that best represents their level of pain, or a healthcare provider may assist in understanding the scale and help the patient choose the appropriate number to describe their pain.
Based on the pain score, pain severity is classified as follows:
Mild pain (1-3): Does not affect sleep. Moderate pain (4-6): Affects sleep. Severe pain (7-10): Significantly disrupts sleep. During the course of treatment, patients are expected to take pain medication as needed. Pain assessments should be performed 20 minutes before the patient takes their pain medication each day.
Measured: 1, 2, and 4 weeks after treatment, as well as at 3, 6, and 12 months
Secondary outcomes (2)
Comparison of local control between RFA/PVA and RFA/PVA combined with SBRT radiotherapy for painful spinal metastases
Evaluate and calculate the DCR of local lesions in two groups of patients at 1, 3, 6, and 12 months after treatment based on the MDA bone response standard.
DCR (Disease Control Rate) refers to the proportion of patients with spinal metastatic tumors who achieve the best therapeutic response according to the The MDA Bone Response Criteria (MD Anderson Bone Response Criteria) is a set of imaging-based criteria used to assess the treatment response in patients with bone metastatic tumors. The criteria are typically applied in clinical trials and research studies to evaluate the effect of various treatments (such as chemotherapy.MDA bone response criteria, as assessed by imaging. This includes patients who achieve Complete Response (CR), Partial Response (PR), or Stable Disease (SD) after treatment.
All patients undergo CT or MRI scans at the designated follow-up time points. The imaging measurements and assessments are performed by the same physician (HJ) who evaluates the results.
Measured: 1, 3, 6, and 12 months after treatment
Compare the limb function of RFA/PVA and RFA/PVA combined with SBRT radiotherapy in the treatment of painful spinal metastases;
Based on the Combined Pain and Ambulatory Function Index, calculate the comprehensive PAFI pain function of two groups of patients at 1, 3, 6, and 12 months after treatment.
Combined Pain and Ambulatory Function Index and Evaluation Time
10 points - Normal walking and recreational activities: No pain or limp. 9 points - Normal walking ability: Mild pain but no limp; no need for walking aids (crutches, cane, walker).
8 points - Walking ability: Moderate pain and mild limp; rarely uses (or prefers not to use) walking aids (crutches, cane, walker).
7 points - Walking ability with walking aids: Severe pain while walking without walking aids; mild pain when using walking aids (crutches, cane, walker).
6 points - Walking ability with walking aids: Moderate pain when using walking aids (crutches, cane, walker).
5 points - Walking with walking aids: Severe pain and significant limping when using walking aids (crutches, cane, walker).
4 points - Unable to walk, using a wheelchair: Can sit in
Measured: 1, 3, 6, and 12 months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start1 Jan 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal MetastasesStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Third Affiliated Hospital of Southern Medical University, Peking University People's Hospital
- Responsible party
- Principal investigator, Dongqing Zuo, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Dongqing Zuo, M.D./PH.D., Study director, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756087
- Sponsor's protocol ID
- 20240912033813578
- Status last verified
- Nov 2024
- First submitted
- 16 Dec 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 1. Ethical Concerns Participant Confidentiality: Even with de-identification, there is a risk that participants could be re-identified, especially in small or unique populations. Consent Limitations: Participants may not have explicitly consented to sharing their data for secondary use or may have only agreed to specific types of research. 2. Risk of Misuse Misinterpretation of Data: Secondary users might misinterpret the data due to a lack of context or understanding of the study. Data Misuse: There is a risk that the data could be used for purposes that contradict the original intent of the research or that harm participants or specific groups.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Ablation/Vertebroplasty Versus Radiofrequency Ablation/Vertebroplasty Combined with SBRT for Painful Spinal Vertebral Metastases: a Multicenter, Practical, Randomized, Controlled, Non-Inferiority Clinical Study
- ClinicalTrials.gov ID
- NCT06756087
- Acronym / sponsor ID
- 20240912033813578
- Conditions
- Spinal Metastases, Local Control, Pain Cancer
- Keywords
- spinal metastases, Radiofrequency Ablation, Stereotactic radiotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- The Third Affiliated Hospital of Southern Medical University, Peking University People's Hospital
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Jan 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 study is a prospective, multicenter, open, practical, randomized controlled, non inferiority effect clinical study initiated by researchers, which aims to evaluate the clinical efficacy and safety of radiofrequency ablation/vertebroplasty and radiofrequency ablation/vertebroplasty combined with SBRT in the treatment of painful spinal metastases. This study plans to include about 120 cases in about 3 research centers nationwide, including the Department of bone oncology of Shanghai First People's Hospital (main center, 60 cases), the Department of bone oncology of the Third Affiliated Hospital of Southern Medical University (sub center 1, 30 cases), and the Department of bone oncology of Peking University People's Hospital (sub center 2, 30 cases). The patient was diagnosed with spinal metastasis of malignant tumor and had pain of more than 3 points. The subjects with spinal metastasis located at t5-l5 were selected for clinical research. All patients were treated with RFA/PVA minimally invasive surgery. In principle, no more than 2 vertebral bodies were treated. All patients will receive MRI/CT examination of the affected spine within 6 weeks before enrollment to determine the degree of spinal involvement. All patients were randomly divided into experimental group and control group after minimally invasive surgery, the ratio was 1:1. The patients in the experimental group recovered to the original system treatment about two weeks after minimally invasive surgery; The control group began to receive SBRT radiotherapy of the surgical vertebral body in about two weeks, and the radiotherapy time was two weeks. According to the recommendations of the Department of radiotherapy, SBRT radiotherapy should use any of the following dose and grading scheme: 4 times 24gy, 5 times 30Gy, 6 times 36Gy, 7 times 42GY. The patients in the two groups were followed up after treatment, and evaluated at 1, 2 and 4 weeks and 3, 6 and 12 months after treatment. The NRPS pain degree and pafi pain function comprehensive score were evaluated, and the local lesions were evaluated at 1, 3, 6 and 12 months after operation. To evaluate the local control of spinal metastases, pain improvement and quality of life changes of the two treatment strategies.
Detailed description
This study is a prospective, multicenter, open, practical, randomized controlled, non inferiority effect clinical study initiated by researchers, which aims to evaluate the clinical efficacy and safety of radiofrequency ablation/vertebroplasty and radiofrequency ablation/vertebroplasty combined with SBRT in the treatment of painful spinal metastases. This study plans to include about 120 cases in about 3 research centers nationwide, including the Department of bone oncology of Shanghai First People's Hospital (main center, 60 cases), the Department of bone oncology of the Third Affiliated Hospital of Southern Medical University (sub center 1, 30 cases), and the Department of bone oncology of Peking University People's Hospital (sub center 2, 30 cases). The patient was diagnosed with spinal metastasis of malignant tumor and had pain of more than 3 points. The subjects with spinal metastasis located at t5-l5 were selected for clinical research. All patients were treated with RFA/PVA minimally invasive surgery. In principle, no more than 2 vertebral bodies were treated. All patients will receive MRI/CT examination of the affected spine within 6 weeks before enrollment to determine the degree of spinal involvement. All patients were randomly divided into experimental group and control group after minimally invasive surgery, the ratio was 1:1. The patients in the experimental group recovered to the original system treatment about two weeks after minimally invasive surgery; The control group began to receive SBRT radiotherapy of the surgical vertebral body in about two weeks, and the radiotherapy time was two weeks. According to the recommendations of the Department of radiotherapy, SBRT radiotherapy should use any of the following dose and grading scheme: 4 times 24gy, 5 times 30Gy, 6 times 36Gy, 7 times 42GY. The patients in the two groups were followed up after treatment, and evaluated at 1, 2 and 4 weeks and 3, 6 and 12 months after treatment. The NRPS pain degree and pafi pain function comprehensive score were evaluated, and the local lesions were evaluated at 1, 3, 6 and 12 months after operation. To evaluate the local control of spinal metastases, pain improvement and quality of life changes of the two treatment strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency ablation/vertebroplasty | Experimental | Radiation: Radiofrequency Ablation (RFA)/Vertebroplasty+Stereotactic RadiotherapyPatients underwent OsteoCool radiofrequency ablation and vertebroplasty for spinal metastatic tumors. After the operation, the original anti-tumor treatment was continued within 1-2 weeks according to the recovery. Local intervention was no longer carried out at the operation site, and the normal follow-up was started. |
| Standard control: Ablation/Vertebroplasty and SBRT Radiotherapy | Other | Procedure: ExperimentalPatients underwent OsteoCool radiofrequency ablation and vertebroplastyfor spinal metastatic tumors. Then were sent to SBRT radiotherapy 2-3 weeks postoperatively. follow-up visit start at the end of adiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The subject voluntarily participates in this study, and both the patient and their family sign an informed consent form. The subject demonstrates good compliance and cooperates with follow-up.
- Age 18 or older, no gender restrictions.
- The target population for this trial consists of patients with bone metastases from malignant tumors confirmed by pathology or imaging, with lesions located between T5 and L5. The number of affected vertebral sites is fewer than three, and the lesions are mainly osteolytic, affecting primarily the vertebral bodies.
- Expected survival is greater than three months.
- Initial diagnosis with an NPRS pain score > 3.
Key exclusion criteria (14 listed)
- Subjects with no measurable lesions;
- Known brain metastasis and/or clinically suspected brain metastasis (subjects with asymptomatic brain metastasis or clinically stable brain metastasis for more than three months after local treatment can be included);
- Subjects whose target lesions received radiotherapy within the past two years;
- Tumor types sensitive to radiotherapy, including malignant lymphoma, testicular seminoma, Wilms tumor, neuroblastoma, medulloblastoma, Ewing sarcoma, and small cell tumors.
- Spinal metastases involving spinal appendages, destruction of the posterior wall of the vertebral canal, or compression of the spinal dura mater;
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 |
|---|---|---|
| Radiofrequency Ablation (RFA)/Vertebroplasty+Stereotactic RadiotherapyAll patients received OsteoCool™ radiofrequency ablation + vertebroplasty for spinal metastatic tumors at the Department of Bone Oncology, Shanghai First People's Hospital. Standard Control Group: Patients received SBRT (Stereotactic Body Radiation Therapy) from the Department of Radiation Oncology 2-3 weeks post-surgery. This included pre-radiation positioning, mold preparation, and radiation therapy. After radiation therapy, patients rested for 2 weeks before resuming their original anti-tumor treatment and starting follow-up.SBRT therapy was administered according to the recommendations, using one of the following dose and fractionation schemes: 4 sessions of 24 Gy, 5 sessions of 30 Gy, 6 sessions of 36 Gy, or 7 sessions of 42 Gy. | Radiation | Radiofrequency ablation/vertebroplasty |
| Experimentalpatients received OsteoCool™ radiofrequency ablation+vertebroplasty for spinal metastatic tumors at the Department of Bone Oncology, Shanghai First People's Hospital. patients continued their original anti-tumor treatment within 1-2 weeks based on their recovery. No further local intervention was performed at the surgical site, and normal follow-up was started. | Procedure or surgery | Standard control: Ablation/Vertebroplasty and SBRT Radiotherapy |
Primary outcome
Compare the pain control of RFA/PVA and RFA/PVA combined with SBRT radiotherapy for painful spinal metastases.
Time frame: 1, 2, and 4 weeks after treatment, as well as at 3, 6, and 12 months
Based on NRPS pain score: Compare the pain scores of two groups of patients at 1, 2, and 4 weeks after treatment, as well as at 3, 6, and 12 months after treatment. The Numerical Pain Rating (NPR) Scale is used to assess the intensity of a patient's pain. The pain intensity is rated using numbers from 0 to 10, where 0 represents no pain, and 10 represents the most intense pain imaginable. The patient is asked to select a number that best represents their level of pain, or a healthcare provider may assist in understanding the scale and help the patient choose the appropriate number to describe their pain. Based on the pain score, pain severity is classified as follows: Mild pain (1-3): Does not affect sleep. Moderate pain (4-6): Affects sleep. Severe pain (7-10): Significantly disrupts sleep. During the course of treatment, patients are expected to take pain medication as needed. Pain assessments should be performed 20 minutes before the patient takes their pain medication each day.
2 secondary outcomes
Comparison of local control between RFA/PVA and RFA/PVA combined with SBRT radiotherapy for painful spinal metastases
Time frame: 1, 3, 6, and 12 months after treatment
Compare the limb function of RFA/PVA and RFA/PVA combined with SBRT radiotherapy in the treatment of painful spinal metastases;
Time frame: 1, 3, 6, and 12 months after treatment.
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 1 Jan 2025.
- Individual participant dataSharing planned: No. 1. Ethical Concerns Participant Confidentiality: Even with de-identification, there is a risk that participants could be re-identified, especially in small or unique populations. Consent Limitations: Participants may not have explicitly consented to sharing their data for secondary use or may have only agreed to specific types of research. 2. Risk of Misuse Misinterpretation of Data: Secondary users might misinterpret the data due to a lack of context or understanding of the study. Data Misuse: There is a risk that the data could be used for purposes that contradict the original intent of the research or that harm participants or specific groups.
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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.
Dongqing Zuo, M.D./PH.D. study director
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency Ablation (RFA)/Vertebroplasty+Stereotactic Radiotherapy and Experimental in people with Spinal Metastases and Local Control, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine 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 8 inclusion and 14 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: opening soon, as of the sponsor's last update on 1 Jan 2025. 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 Dongqing Zuo, M.D./PH.D. (+86-02136123520, dongqing.zuo1@shgh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the pain control of RFA/PVA and RFA/PVA combined with SBRT radiotherapy for painful spinal metastases. (time frame: 1, 2, and 4 weeks after treatment, as well as at 3, 6, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jan 2025.