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NCT05665439 Clinical Trial

Local Treatment for Bone Metastases

Bone Metastases Clinical Trial

Official title:
Study on Local Treatment for Patients With Bone Metastases

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05665439
Other study ID # 20221201
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 2023
Est. completion date March 2026

Study information
Verified date February 2023
Source Shanghai 6th People's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 348
Est. completion date March 2026
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Radiation:
• radiation
radiation for patients with newly diagnosed bone metastases or patients with bone metastases after vertebroplasty

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Shanghai 6th People's Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Disease control rate at 1 year Disease control rate 1 year
Secondary Progression-Free Survival 1 year
Secondary Overall Survival 1 year
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