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
1) Be able to sign written informed consent.
2) Age range from 18 to 75 years old, regardless of gender.
3) 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.
4) 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.
1) Primary tumors of the spine or multiple tumors of the body, with>3 metastatic organs and>5 metastatic sites.
2) Previously underwent spinal surgery, or received radiotherapy for the responsible segment of this treatment.
3) Severe heart, lung, liver, kidney or other diseases affecting the surgery.
4) Having cognitive impairment, sensory aphasia, and inability to understand basic instructions.
According to the literature results, the median survival period of the experimental group was 20 months, while the median survival period of the control group was 11 months. The total study duration (enrollment+follow-up) was 48 months, and the enrollment time (assuming uniform enrollment speed) was 24 months. The bilateral alpha was 0.05, the beta was 0.2, and the ratio of sample size between the two groups was 2 (experimental group: control group). Through the difference test of median survival time, the experimental sample size was calculated: 110 cases in the experimental group, 55 cases in the control group, a total of 165 cases, Considering 10% detachment, a total of 182 samples are required.
Cohort
Prospective
total en bloc spondylectomy
Procedure/SurgeryTotal enbloc resection (TES) is one of the most challenging surgeries in spinal surgery and a classic surgical method. It not only relieve spinal cord compression and delays tumor recurrence, but also prolongs patient survival, significantly reduces hand surgery trauma, and improves surgical safety. However, for cases with extensive tumor invasion, methods such as separation surgery should be used to relieve spinal cord nerve compression, rebuild spinal stability, and provide conditions for postoperative radiotherapy.
Overall Survival(OS)
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.
Local Control Rate(LRC)
Based on the Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1), it is defined as 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.
Progression-Free Survival(PFS)
The period between the patient receiving this treatment and observing local progression or death from any cause. Based on the changes in patient imaging and neurological function, comprehensively evaluate whether the local lesion of the spine is progressing.
Brief Pain inventory
Use the Brief Pain Inventory (BPI) to score the pain levels 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.
EORTC Quality of Life Questionnaire - Core 30
Evaluate the quality of life of patients 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 using EORTC Quality of Life Questionnaire - Core 30
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Shanghai Changzheng Hospital
Lead sponsor
Peking University Third Hospital
Collaborator
Peking University People's Hospital
Collaborator
Henan Cancer Hospital
Collaborator
First Affiliated Hospital, Sun Yat-Sen University
Collaborator
Sun Yat-sen University
Collaborator
Zhejiang University
Collaborator
Tianjin Hospital
Collaborator
The First Affiliated Hospital of Nanchang University
Collaborator
The Third Affiliated Hospital of Southern Medical University
Collaborator
