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

Launched by SHANGHAI GENERAL HOSPITAL, SHANGHAI JIAO TONG UNIVERSITY SCHOOL OF MEDICINE · Dec 24, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring two different treatment methods for managing pain from spinal metastases, which are cancerous tumors that have spread to the spine. The researchers want to find out if combining a procedure called radiofrequency ablation and vertebroplasty (which helps relieve pain and stabilize the spine) with a type of targeted radiation therapy known as SBRT is more effective than using just the first two treatments alone. They plan to recruit about 120 patients across three hospitals in China, focusing on those who have painful spinal metastases located between the T5 and L5 vertebrae.

To participate in this study, patients need to be at least 18 years old and have confirmed spinal metastases that are causing significant pain (rated above a 3 on a scale). They should also have a good overall health status and be expected to live for at least three more months. After a minimally invasive surgery, participants will be randomly assigned to either receive the combined treatment or just the initial treatment before starting SBRT. Throughout the study, patients will be monitored for pain relief and overall quality of life at several follow-up appointments. This trial aims to provide valuable insights into how to better manage pain for those suffering from spinal metastases.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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.
• • 2. Age 18 or older, no gender restrictions.
• • 3. 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.
• • 4. Expected survival is greater than three months.
• • 5. Initial diagnosis with an NPRS pain score \> 3.
• • 6. ECOG performance status score of 0-2.
• • 7. 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.
• • 8. 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:
• • 1. Subjects with no measurable lesions;
• • 2. 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);
• • 3. Subjects whose target lesions received radiotherapy within the past two years;
• • 4. Tumor types sensitive to radiotherapy, including malignant lymphoma, testicular seminoma, Wilms tumor, neuroblastoma, medulloblastoma, Ewing sarcoma, and small cell tumors.
• • 5. Spinal metastases involving spinal appendages, destruction of the posterior wall of the vertebral canal, or compression of the spinal dura mater;
• • 6. Subjects preparing for or who have previously undergone tissue/organ transplantation;
• • 7. Subjects with active infections or unexplained fever \>38.5℃ during screening or before treatment;
• • 8. Patients with active pulmonary tuberculosis (TB), currently receiving anti-TB treatment or treated for TB within the past year before screening;
• • 9. Positive syphilis serology test;
• • 10. Known history of HIV-positive test or known acquired immunodeficiency syndrome (AIDS);
• • 11. 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;
• • 12. 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;
• • 13. Uncontrolled hypertension (defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg despite standardized antihypertensive treatment);
• • 14. 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.