Clinical trial NCT05577052: SBRT Versus Conventional Fractionated Radiotherapy for Vertebral Metastases
Official title: SBRT Versus Conventional Fractionated Radiotherapy for Vertebral Metastases From Non-small Cell Lung Cancer, an Open, Randomized Phase II Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: NSCLC
Keywords: SBRT, NSCLC, Vertebral metastasis
Lead sponsor: Wuhan University
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Complete pain relief rate
timeFrame: 3 months
Secondary outcomes:
measure: Quality of life scores
timeFrame: 3 months and 6 months
Other outcomes:
Locations:
Study officials:
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