SBRT Versus Conventional Fractionated Radiotherapy for Vertebral Metastases (NCT05577052) | Clinical Trial Compass
UnknownNot Applicable
SBRT Versus Conventional Fractionated Radiotherapy for Vertebral Metastases
100 participantsStarted 2022-10-30
Plain-language summary
Vertebral metastases are events that affect the quality of life of tumor patients, and are often accompanied by severe pain at the site of metastasis and even by the risk of compression fracture. For vertebral metastases who are not yet at risk of vertebral instability fracture, a moderate dose (30Gy/10F) external radiation therapy is the most widely used treatment technique. Previous studies have shown that 60-80% of patients could achieve pain relief with moderate doses of radiation therapy, with median pain control duration of approximately 4 months. Stereotactic Radiation Therapy (SBRT) is currently the most advanced radiation therapy technique. This project proposes to treat vertebral metastases from non-small cell lung cancer using SBRT technology on the True Beam radiotherapy system to compare its efficacy with conventional external irradiation technology in terms of pain relief as well as local control.
Who can participate
Age range
18 Years – 80 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:
* Pathologically confirmed stage IV non-small cell lung cancer.
* General condition score ≤ 2.
* With vertebral metastases combined with painful symptoms.
* Absence of neurological symptoms due to vertebral metastases, such as dyskinesia, defecation or urination abnormalities.
* No previous radiation treatment of any kind to the vertebral body.
* The metastatic vertebra has not been treated surgically
* Vertebral stability score (SINS) ≤ 12
* Patient life expectancy of more than 6 months.
Exclusion Criteria:
* Small cell cell lung cancer or large cell carcinoma
* General condition score \>2, intolerant of radiotherapy.
* Comorbid neurological symptoms such as dyskinesia, abnormal bowel movements or urination
* Metastatic vertebrae that have received radiotherapy or surgical intervention
* Vertebral stability score (SINS) \>12
* Patient life expectancy of less than 6 months
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.