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.
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.
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.
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Lead sponsor
The Third Affiliated Hospital of Southern Medical University
Collaborator
Peking University People's Hospital
Collaborator