An interventional study of radiotherapy in Spinal Metastases, Spinal Tumor and Radiotherapy, sponsored by Wei Xu. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Wei Xu · Not applicable, Interventional, and Treatment
The aim of this clinical study is to explore the impact of whether radiotherapy is administered after spinal metastasis surgery on the prognosis and survival of patients, to describe the clinical outcomes, and to optimize future clinical decisions.
Based on the GLOBOCAN 2020 report, there were approximately 19.3 million new cancer cases and 10 million cancer-related deaths worldwide in 2020. The spine is one of the most common sites for metastatic malignancies, with approximately 30%-70% of patients with malignant tumors developing spinal metastases. Malignant spinal metastases can lead to symptoms such as pain, hypercalcemia, spinal instability, vertebral pathological fractures, and compression of the spinal cord and nerve roots. If the symptoms of bone metastases are not effectively controlled, they can cause psychological problems such as pain, anxiety, depression, despair, and loneliness, severely impacting the quality of life and accelerating the process of death.
The primary treatment goal for patients with spinal metastatic cancer is palliative care, which includes the preservation of neurological function, local tumor control, restoration of spinal stability, and alleviation of associated symptoms to improve the quality of life of patients. Separation surgery followed by postoperative radiotherapy is currently one of the most common treatment regimens for spinal metastatic cancer patients. Although postoperative radiotherapy can provide some degree of local control over spinal metastases, radiotherapy is associated with potential risks, such as radiation-induced myelitis, vertebral compression fractures, local control failure, and surgical wound infections. Moreover, radiotherapy is ineffective in 20-30% of patients. Furthermore, the maximum cumulative radiation dose tolerable by the spinal cord is 45-50Gy, beyond which the spine can no longer receive radiotherapy. In recent years, significant breakthroughs in systemic therapies such as targeted therapy and immunotherapy have dramatically improved local control and survival rates for various spinal metastatic cancers (such as lung, breast, and prostate cancer); in some cases, systemic therapy alone can effectively control spinal metastases.
The Spine Tumor Center at Shanghai Changzheng Hospital is continuously dedicated to exploring and researching new treatment methods for spinal metastatic cancer. In this clinical trial, we aim to compare data from spinal metastatic cancer patients with indications for separation surgery who undergo systemic therapy alone following separation surgery with those who undergo radiotherapy after separation surgery at the same center. Through a rigorous prospective cohort study, we hope to provide new and effective treatment strategies for the control of local lesions and improvement in the quality of life for spinal metastatic cancer patients.
105 studies on the registry are indexed under Spinal Cord Neoplasms; 27 are open to participants now.
This study's planned enrollment of 130 is above the median of 50 across 69 interventional studies indexed under Spinal Cord Neoplasms.
Browse Spinal Cord Neoplasms studies →Wei Xu is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The patients with this arm do not receive radiotherapy after the separation surgery.
Patients with spinal metastasis undergo radiotherapy after the separation surgery.
Radiation: radiotherapy
The patients receive radiotherapy after the separation surgery.
Progression-Free Survival (PFS)
Time from the date of surgery to the first documented disease progression or death from any cause, whichever occurs first.
Time frame: Baseline up to 24 months.
Overall Survival（OS）
From the date of surgery until the date of death from any cause.
Time frame: Baseline up to 24 months.
Pain Assessment
Visual Analogue Scale (VAS)
Time frame: One day before the operation, within 2 weeks after the operation, 3 months after the operation, 6 months after the operation, 12 months after the operation, 18 months after the operation, and 24 months after the operation.
Quality of Life Evaluation
EORTC QLQ-C30 V3.0 Scale
Time frame: One day before the operation, within 2 weeks after the operation, 3 months after the operation, 6 months after the operation, 12 months after the operation, 18 months after the operation, and 24 months after the operation.
Complications
All related complications after the surgery.
Time frame: Baseline up to 24 months.
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