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SBRT Versus Conventional Fractionated Radiotherapy for Vertebral Metastases

Sponsor
Wuhan University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05577052
Collaborator
(none)
100
Enrollment
2
Arms
26
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Metastatic vertebrae treated with SBRT
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
SBRT Versus Conventional Fractionated Radiotherapy for Vertebral Metastases From Non-small Cell Lung Cancer, an Open, Randomized Phase II Study
Anticipated Study Start Date :
Oct 30, 2022
Anticipated Primary Completion Date :
Nov 1, 2024
Anticipated Study Completion Date :
Dec 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Complete pain relief rate [3 months]

    Complete pain relief rate after completion of radiotherapy

Secondary Outcome Measures

  1. Quality of life scores [3 months and 6 months]

    Quality of life score after radiotherapy

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Wuhan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Conghua Xie,MD,PhD, Professor, Wuhan University
ClinicalTrials.gov Identifier:
NCT05577052
Other Study ID Numbers:
  • SBRT for vertebral metastases
First Posted:
Oct 13, 2022
Last Update Posted:
Oct 13, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Conghua Xie,MD,PhD, Professor, Wuhan University
SBRT, NSCLC, Vertebral metastasis
Additional relevant MeSH terms:
Neoplasm Metastasis

Study Results

No Results Posted as of Oct 13, 2022