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Trial Title:
SBRT Versus Conventional Fractionated Radiotherapy for Vertebral Metastases
NCT ID:
NCT05577052
Condition:
NSCLC
Conditions: Official terms:
Neoplasm Metastasis
Conditions: Keywords:
SBRT, NSCLC, Vertebral metastasis
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Metastatic vertebrae treated with SBRT
Description:
High-dose SBRT treatment
Arm group label:
Control group
Arm group label:
Test group
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Start date:
October 30, 2022
Completion date:
December 30, 2024
Lead sponsor:
Agency:
Wuhan University
Agency class:
Other
Source:
Wuhan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05577052
