Local Treatment for Bone Metastases | NCT05665439

Studies
Local Treatment for Bone Metastases

NCT05665439

Sponsor

Shanghai 6th People's Hospital

Status

Unknown status

Last Update Posted

Mar 2, 2023Actual

Enrollment

348Estimated

Phase

Not Applicable

Conditions

Bone Metastases

Interventions

radiation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2023Estimated

Primary Completion Date

Mar 2025Estimated

Completion Date

Mar 2026Estimated

First Submitted Date

Dec 17, 2022

First Submission Date that Met QC Criteria

Dec 17, 2022

First Posted Date

Dec 27, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2023

Last Update Posted Date

Mar 2, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zhao Hui, Principal Investigator, Shanghai 6th People's HospitalPrincipal Investigator

Lead Sponsor

Shanghai 6th People's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

348Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
local treatment	Experimental		Radiation: radiation
observation	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
radiation	Radiation	radiation for patients with newly diagnosed bone metastases or patients with bone metastases after vertebroplasty	local treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Disease control rate at 1 year	Disease control rate	1 year

Secondary Outcomes

Measure	Description	Time Frame
Progression-Free Survival		1 year
Overall Survival		1 year

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided