Back to resultsLocal Treatment for Bone Metastases
Primary Purpose
Bone Metastases
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
radiation
Sponsored by
About this trial
This is an interventional treatment trial for Bone Metastases
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; ECOG：0-1； 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
local treatment
observation
Arm Description
Outcomes
Primary Outcome Measures
Disease control rate at 1 year
Disease control rate
Secondary Outcome Measures
Progression-Free Survival
Overall Survival
Full Information
NCT ID
NCT05665439
First Posted
December 17, 2022
Last Updated
February 28, 2023
Sponsor
Shanghai 6th People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05665439
Brief Title
Local Treatment for Bone Metastases
Official Title
Study on Local Treatment for Patients With Bone Metastases
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai 6th People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Metastases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
348 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
local treatment
Arm Type
Experimental
Arm Title
observation
Arm Type
No Intervention
Intervention Type
Radiation
Intervention Name(s)
radiation
Intervention Description
radiation for patients with newly diagnosed bone metastases or patients with bone metastases after vertebroplasty
Primary Outcome Measure Information:
Title
Disease control rate at 1 year
Description
Disease control rate
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Progression-Free Survival
Time Frame
1 year
Title
Overall Survival
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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;
ECOG：0-1；
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.
12. IPD Sharing Statement
Learn more about this trial
Local Treatment for Bone Metastases
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