A randomized controlled trial for evaluating pain response in patients with spinal metastases following local versus whole vertebral radiotherapy: study protocol for phase II clinical trial

BACKGROUND: Patients with bone metastasis often experience severe pain that is difficult to control and seriously affects quality of life. Radiotherapy is an effective way to relieve pain in these patients. Currently, there is no standard recommended range of radiotherapy targets for vertebral metastasis. The effect of radiotherapy on pain relief varies among patients, and some patients with metastases have serious side effects. METHODS: This study aims to verify whether reducing the radiotherapy range for vertebral metastases can achieve the same effect as whole vertebral radiotherapy while minimizing side effects. Sixty-six patients with pain caused by vertebral metastasis were randomly divided into two groups. The study group is receiving partial vertebrae body radiotherapy at the regions of abnormal signal, suspected invasion, and adjacent subclinical focus of vertebral metastasis, and the control group is receiving the same dose of radiotherapy on whole vertebrae body where metastasis occurred. After radiotherapy, along-term follow-up of patients will determine pain relief and side effects. DISCUSSION: The expected results of this study are that local irradiation of vertebral metastases can achieve a palliative effect of pain control not less than total vertebral irradiation with fewer side effects. TRIAL REGISTRATION: This study was registered in the Chinese Clinical Trial Registry (No: ChiCTR1900023401).