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Clinical Trials/NCT05665439
NCT05665439
Not yet recruiting
Not Applicable

Study on Local Treatment for Patients With Bone Metastases

Shanghai 6th People's Hospital0 sites348 target enrollmentMarch 2023
ConditionsBone Metastases

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bone Metastases
Sponsor
Shanghai 6th People's Hospital
Enrollment
348
Primary Endpoint
Disease control rate at 1 year
Status
Not yet recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2023
End Date
March 2026
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Zhao Hui

Principal Investigator

Shanghai 6th People's Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Disease control rate at 1 year

Time Frame: 1 year

Disease control rate

Secondary Outcomes

  • Overall Survival(1 year)
  • Progression-Free Survival(1 year)

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