SBRT Versus Conventional Fractionated Radiotherapy for Vertebral Metastases

NCT05577052 | Unknown

• 1 other identifier: SBRT for vertebral metastases
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

NSCLC

Keywords

SBRT, NSCLC, Vertebral metastasis

Outcome Measures

Primary Outcomes (1)

• Complete pain relief rate

  Complete pain relief rate after completion of radiotherapy

  3 months

Secondary Outcomes (1)

• Quality of life scores

  3 months and 6 months

Study Arms (2)

Test group

EXPERIMENTAL

Metastatic vertebrae treated with SBRT

Radiation: Metastatic vertebrae treated with SBRT

Control group

OTHER

Conventional radiation dose to vertebral metastases

Radiation: Metastatic vertebrae treated with SBRT

Interventions

Metastatic vertebrae treated with SBRT RADIATION

High-dose SBRT treatment

Control group; Test group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wuhan University: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Jing Yu, Dr

CONTACT

02767812539; yujingrt@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 8, 2022
• First Posted: October 13, 2022
• Study Start: October 30, 2022
• Primary Completion: November 1, 2024
• Study Completion: December 30, 2024
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 2 years of sharing after 3 months