A Single-center Observational Clinical Trial of Stereotactic Radiotherapy on Metastatic Spinal Tu… (NCT05808998) | Clinical Trial Compass
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A Single-center Observational Clinical Trial of Stereotactic Radiotherapy on Metastatic Spinal Tumors Using TomoTherapy
45 participantsStarted 2023-04-01
Plain-language summary
A single-center observational clinical trial will be performed for metastatic spinal tumors by stereotactic radiotherapy using TomoTherapy. In this study, we will explore the local control rate (LCR), disease-free progression time (PFS), overall survival time (OS), and pain relief in patients with spinal metastasis, so as to provide a basis for developing relevant guidelines or consensus.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Spinal metastasis diagnosed by emission computed tomography, X-ray examination, computed tomography, magnetic resonance imaging (MRI) or 18F-fluorodeoxy glucose positron emission tomography within 6 weeks before enrollment;
. Patients with unresectable spinal metastases;
. SBRT was for patients with painful spinal metastases, physiological hypofunction, decreased behavioral capacity and quality of life. And SBRT was used to help to prevent or delay skeletal related event (SRE). Including postoperative radiotherapy (especially post-separation), single or salvage radiotherapy;
. age 18-75 years old;
. KPS score equal to 70 points or over;
. Patients were required to have histologically confirmed metastatic disease from solid tumors, such as breast cancer, renal carcinoma or liver cancer;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. The distance between metastatic lesion and spinal cord was more than 3mm；
. Hemoglobin \>90g/L, white cells count≥3.5×109/L, platelet count≥80×109/L, within 1 week before treatment;
Exclusion criteria
. Spinal cord or cauda equina compression, the rapid decrement of neurological function or paralysis;
. A compression fracture of the spine, spinal instability and subsequent inability to lie on back;
. Metastatic lesions more than 5cm;
. Multilevel segments involvement, including more than 5 metastatic segments, or 3 isolated lesions, or exceed two adjacent vertebrae;
. The treatment site had received prior radiotherapy prior to the initiation of the study;
. Complicated with other malignant tumors or severe internal diseases affected the prognosis;
. Cannot tolerate radiation therapy, including the ones with scleroderma or connective tissue diseases, or cann't complete the radiation treatment according to the research;