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

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 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

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-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.

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.

Sponsors & Collaborators

• The Third Affiliated Hospital of Southern Medical University

  collaborator OTHER_GOV

• Peking University People's Hospital

  collaborator OTHER

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  lead OTHER

Principal Investigators

• Dongqing Zuo, M.D./PH.D. · Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-01

Primary Completion

2026-06-30

Completion

2026-12-31

Countries

• China

Study Locations