Postoperative Radiotherapy Versus No Radiotherapy Following Separation Surgery for Spinal Metastases: A Mixed Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Wei Xu
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years old, gender not limited;
- •The patient has undergone separation surgery within 3 weeks;
- •The pathological result of the separation surgery site of the patient indicates that the lesion is a metastatic tumor, and the primary lesion is located outside the spine;
- •The expected survival period is ≥ 6 months;
- •The patient has signed the informed consent form.
排除标准
- •Patients with poor general condition and those who are intolerant to radiotherapy, chemotherapy, and targeted therapy;
- •Patients whose treatment segments have not received any other surgical treatment or radiotherapy;
- •Patients who participated in other clinical trials of drugs or medical devices within 3 months before enrollment;
- •Other situations judged by the investigator as making the subject unsuitable for enrollment.
研究组 & 干预措施
No Radiotherapy Arm
The patients with this arm do not receive radiotherapy after the separation surgery.
Postoperative Radiotherapy Arm.
Patients with spinal metastasis undergo radiotherapy after the separation surgery.
干预措施: radiotherapy (Radiation)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Baseline up to 24 months.
Time from the date of surgery to the first documented disease progression or death from any cause, whichever occurs first.
次要结局
- Overall Survival（OS）(Baseline up to 24 months.)
- Pain Assessment(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(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(Baseline up to 24 months.)
研究者
Wei Xu
Shanghai Changzheng Hospital
Shanghai Changzheng Hospital