SBRT Versus Conventional Fractionated Radiotherapy for Vertebral Metastases

Wuhan University

Status: Not yet enrolling

Conditions: NSCLC

Treatments: Radiation: Metastatic vertebrae treated with SBRT

Study type: Interventional

Funder types: Other

Identifiers

NCT05577052

SBRT for vertebral metastases

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Test group

Experimental group

Description:

Metastatic vertebrae treated with SBRT

Treatment:

Radiation: Metastatic vertebrae treated with SBRT

Control group

Other group

Description:

Conventional radiation dose to vertebral metastases

Treatment:

Radiation: Metastatic vertebrae treated with SBRT