En Bloc Resection Versus Separation Surgery Combined With Radiotherapy for the Treatment of Spinal Oligometastatic Tumor-A Multi-center, Prospective, Randomized, Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- Overall Survival(OS)
研究概览
简要总结
The purpose of this clinical trial is to explore the impact of En bloc surgery and separation surgery combined with radiation therapy on the prognosis and survival of patients with spinal oligometastatic cancer, describe the clinical results, and optimize future treatment goals
详细描述
Patients with oligometastatic diseases have been shown to have better prognosis than those with multiple metastatic diseases, and some patients have achieved long-term survival, thus being considered to benefit from more aggressive treatment. Active local treatment, including surgery and/or targeted radiotherapy, such as Stereotactic Radiosurgery (SRS) and Stereotactic body radiotherapy (SBRT), can be performed before or after systemic treatment. For both primary and oligometastatic tumors, radical treatment should be considered in order to achieve better survival and prognosis. The current research has explored the different effects of oligometastatic disease status on the prognosis of various cancers. However, there is currently no clear clinical or experimental confirmation of the impact on the survival and treatment outcomes of patients with oligometastatic spinal cancer. The purpose of this clinical trial is to explore the impact of En bloc hand surgery and separation surgery combined with radiotherapy on the prognosis and survival of patients with oligometastatic spinal cancer, Describe clinical outcomes and optimize future treatment goals
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be able to sign written informed consent.
- •Age range from 18 to 75 years old, regardless of gender.
- •Within conservative treatment, the patient still has uncontrollable pain, metastatic cancer lesions that still progress, spinal instability/potential instability, or symptoms of spinal cord/nerve compression.
- •After the patient underwent Positron Emission Tomography-Computed Tomography (PET-CT) examination, it was indicated that there were no more than 3 metastatic organs and no more than 5 metastatic lesions in the whole body of cancer. Among them, there was at least 1 spinal metastasis and at most 5 spinal metastases.
- •Imaging examinations (enhanced MRI, enhanced CT, X-ray) indicate the presence of spinal metastasis.
- •The expected survival period is ≥ 6 months.
- •No other surgical contraindications
排除标准
- •Primary tumors of the spine or multiple tumors of the body, with>3 metastatic organs and>5 metastatic sites.
- •Previously underwent spinal surgery, or received radiotherapy for the responsible segment of this treatment.
- •Severe heart, lung, liver, kidney or other diseases affecting the surgery.
- •Having cognitive impairment, sensory aphasia, and inability to understand basic instructions.
- •Participated in clinical trials of other drugs or medical devices within 3 months prior to enrollment.
- •Infectious diseases.
- •Refuse to follow up or participate.
- •The researchers determine that the patients are not suitable for enrollment this clinical trail.
结局指标
主要结局
Overall Survival(OS)
时间窗: after surgery until death due to primary disease or responsible segment
On the basis of maintaining systemic treatment, compare the overall survival period of En bloc surgery and separation surgery combined with radiation therapy for patients with spinal oligometastatic cancer, after surgery until death due to primary disease or responsible segment.
次要结局
- Progression-Free Survival(PFS)(The period between the patient receiving this treatment and observing local progression or death from any cause.)
- Brief Pain inventory(1 day before surgery, 2 weeks after surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery, and 12 months after surgery.)
- Complication(1 month, 3 months, 6 months, and 12 months after surgery.)
- Local Control Rate(LRC)(a 20% increase in the total diameter of the target lesion observed on imaging from the beginning of the patient's current treatment to baseline.)
- EORTC Quality of Life Questionnaire - Core 30(1 day before surgery, 2 weeks after surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery, and 12 months after surgery)
研究者
Jianru Xiao
shanghaiczh
Shanghai Changzheng Hospital