SBRT Versus Conventional Fractionated Radiotherapy for Vertebral Metastases

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: NSCLC
• Intervention / Treatment: Radiation: Metastatic vertebrae treated with SBRT

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jing Yu, Dr; Phone Number: 86 02767812539; Email: yujingrt@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group; Metastatic vertebrae treated with SBRT	Radiation: Metastatic vertebrae treated with SBRT; High-dose SBRT treatment
Other: Control group; Conventional radiation dose to vertebral metastases	Radiation: Metastatic vertebrae treated with SBRT; High-dose SBRT treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete pain relief rate	Complete pain relief rate after completion of radiotherapy	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life scores	Quality of life score after radiotherapy	3 months and 6 months

Collaborators and Investigators

• Sponsor: Wuhan University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 30, 2022
• Primary Completion (Anticipated): November 1, 2024
• Study Completion (Anticipated): December 30, 2024

Study Registration Dates

• First Submitted: October 8, 2022
• First Submitted That Met QC Criteria: October 8, 2022
• First Posted (Actual): October 13, 2022

Study Record Updates

• Last Update Posted (Actual): October 13, 2022
• Last Update Submitted That Met QC Criteria: October 8, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: SBRT, NSCLC, Vertebral metastasis
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: SBRT for vertebral metastases

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Time Frame: 2 years of sharing after 3 months
• IPD Sharing Supporting Information Type: Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No