Local Treatment for Bone Metastases

Not Applicable

Not yet recruiting

• Conditions: Bone Metastases

• Registration Number: NCT05665439
• Lead Sponsor: Shanghai 6th People's Hospital

Brief Summary

This study will carry out a prospective randomized controlled study to study the effect of different local treatment on disease control, quality of life, economic cost and even survival period of patients by randomly giving local radiotherapy or observation to patients with newly diagnosed bone metastases or patients with bone metastases after vertebroplasty.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-17
• Study First Submitted QC: 2022-12-17
• Study First Posted: 2022-12-27
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-28
• Study Start: 2023-03
• Last Update Posted: 2023-03-02
• Primary Completion: 2025-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 348

Inclusion Criteria

1. Patients who are definitely diagnosed as malignant tumor by pathology or cytology;
2. At least one bone metastasis site;
3. Aged over 18;
4. ECOG：0-1；
5. The pain score is less than 5 or after vertebroplasty within 1 month.

Exclusion Criteria

1. The expected life span is less than 3 months;
2. Spinal metastatic tumor stability score (SINS) is greater than 7;
3. Spinal cord compression;
4. The patient refused the treatment decision of the integrated team.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Disease control rate at 1 year	1 year	Disease control rate

Secondary Outcome Measures

Name	Time	Method
Progression-Free Survival	1 year
Overall Survival	1 year