SBRT Versus Conventional Fractionated Radiotherapy for Vertebral Metastases

NSCLC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05577052
• Other study ID #: SBRT for vertebral metastases
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 30, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: October 2022
• Source: Wuhan University
• Contact: Jing Yu, Dr
• Phone: 02767812539
• Email: yujingrt[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 30, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasm Metastasis
• NSCLC

Intervention

Radiation:
• Metastatic vertebrae treated with SBRT
High-dose SBRT treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete pain relief rate	Complete pain relief rate after completion of radiotherapy	3 months
Secondary	Quality of life scores	Quality of life score after radiotherapy	3 months and 6 months