Evaluate the Efficacy of Radiofrequency Ablation/Vertebroplasty with or Without SBRT for Treating Painful Spinal Vertebral Metastases

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

Overview

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.

Interventions

• Radiation Radiofrequency Ablation (RFA)/Vertebroplasty+Stereotactic Radiotherapy
  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-tumo
• Procedure Experimental
  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.

Primary outcome measures

• 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]

Secondary outcome measures (2)

• 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.]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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;
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Sequential

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Shanghai General Hospital — Shanghai

Identifiers

NCT: NCT06756087 · 20240912033813578

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗