Delineation of Target Volume of Stereotactic Radiotherapy for Spinal Tumors

Recruiting

• Conditions: Spinal Tumor
• Interventions: Radiation: Target volume delineation

• Registration Number: NCT06587022
• Lead Sponsor: Peking University Third Hospital

Brief Summary

The purpose of this study was to compare efficacy and side effects of two target delineation methods for stereotactic radiotherapy of metastatic spinal tumors.

Detailed Description

The purpose of this study was to compare efficacy and side effects of two target delineation methods for stereotactic radiotherapy of metastatic spinal tumors. This is a bidirectional cohort study planned to enroll approximately 500 patients with metastatic spinal tumors. Patients are divided into two groups according to the target delineation method. Group 1：The target bolume only includes local tumor. Group 2：The target bolume includes local tumor and adjacent vertebral area.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-01-01
• Status Verified: 2024-08
• Study First Submitted: 2024-09-04
• Study First Submitted QC: 2024-09-04
• Last Update Submitted: 2024-09-04
• Study First Posted: 2024-09-06
• Last Update Posted: 2024-09-06
• Primary Completion: 2026-12-30
• Study Completion: 2027-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Patients with spinal metastases or primary tumors receiving stereotactic radiotherapy;
• Patients with sufficent pre-treatment imaging data
• Patients who can cooperate with imaging review and follow-up after radiotherapy.

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Exclusion Criteria

• Patients with an expected survival of less than 3 months;
• Patients with second-course radiotherapy;
• Patients with physical conditions that cannot tolerate stereotactic radiotherapy;
• Patients with extensive spinal metastasis and no local therapeutic value

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
group 1	Target volume delineation	Group 1(small target delineation)：The target bolume only includes local tumor.
group 2	Target volume delineation	Group 2(small target delineation)：The target bolume includes local tumor and adjacent vertebral area.

Primary Outcome Measures

Name	Time	Method
Disease Control Rate（DCR）	2 years	Disease Control Rate（DCR），including complete response（CR），partial response(PR) and stable disease(SD ).
Pain relief rate	3 months	VAS Score(Visual Analog Scale Score) decreased after treatment

Secondary Outcome Measures

Name	Time	Method
Incidence of side effects	2 years	radiation myelitis,radiation esophagitis, etc.

Trial Locations

Locations (1)

Department of Radiation Oncology Cancer Center, Peking University Third Hospital 49# North Garden Rd.,Haidian Dist.; 🇨🇳 Beijing, Beijing, China