SBRT Versus Conventional Fractionated Radiotherapy for Vertebral Metastases

Study Overview
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Brief Summary
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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.

Detailed Description
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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. It enables focused radiation therapy with small fields through stereotactic techniques. In June 2021, Zhongnan Hospital of Wuhan University introduced the True Beam radiotherapy system, which has a higher treatment rate compared to conventional radiotherapy equipment, while It is the most reliable vehicle to achieve SBRT. Therefore, 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.

Official Title
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SBRT Versus Conventional Fractionated Radiotherapy for Vertebral Metastases From Non-small Cell Lung Cancer, an Open, Randomized Phase II Study

Conditions
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NSCLC

Intervention / Treatment
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* Radiation: Metastatic vertebrae treated with SBRT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br>Metastatic vertebrae treated with SBRT | Radiation: Metastatic vertebrae treated with SBRT<br>* High-dose SBRT treatment<br>|
| Other: Control group<br>Conventional radiation dose to vertebral metastases | Radiation: Metastatic vertebrae treated with SBRT<br>* High-dose SBRT treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete pain relief rate | Complete pain relief rate after completion of radiotherapy | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life scores | Quality of life score after radiotherapy | 3 months and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SBRT, NSCLC, Vertebral metastasis