SBRT Versus Conventional Fractionated Radiotherapy for Vertebral Metastases

NCT ID: NCT05577052

Last Updated: 2022-10-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-30
• Study Completion Date: 2024-12-30

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.

Conditions

NSCLC

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Test group

Metastatic vertebrae treated with SBRT

Group Type: EXPERIMENTAL

Metastatic vertebrae treated with SBRT

Intervention Type: RADIATION

High-dose SBRT treatment

Control group

Conventional radiation dose to vertebral metastases

Group Type: OTHER

Metastatic vertebrae treated with SBRT

Intervention Type: RADIATION

High-dose SBRT treatment

Interventions

Metastatic vertebrae treated with SBRT

High-dose SBRT treatment

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wuhan University

OTHER

Sponsor Role: lead

Responsible Party

Conghua Xie,MD,PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Jing Yu, Dr

Role: CONTACT

yujingrt@163.com

02767812539 ext. 86

Other Identifiers

SBRT for vertebral metastases

Identifier Type: -

Identifier Source: org_study_id