Primary Lesion Treatment for Bone Metastases | NCT05665790

Studies
Primary Lesion Treatment for Bone Metastases

NCT05665790

Sponsor

Shanghai 6th People's Hospital

Status

Unknown status

Last Update Posted

Mar 2, 2023Actual

Enrollment

400Estimated

Phase

Not Applicable

Conditions

Bone Metastases

Interventions

radiotherapy
palliative surgery

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 18, 2022

First Submission Date that Met QC Criteria

Dec 23, 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 cohort study to study the effect of different primary leison treatment modes on disease control, quality of life, economic cost and survival period of patients with bone metastases from breast cancer and lung cancer by giving radiotherapy or palliative surgery or not giving local treatment for the primary lesion in patients with bone metastases from breast cancer or lung cancer

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

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
radiotherapy	Experimental	Radiation: radiotherapy
palliative surgery	Experimental	Procedure: palliative surgery
no primary leison treatment	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
radiotherapy	Radiation	radiotherapy	radiotherapy
palliative surgery

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:

HR positive breast cancer patients with bone metastasis or Non-small-cell lung cancer patients with bone metastasis；
Aged over 18;
ECOG：0-1；
Patients who benefit clinically(CR+PR) after 6 months of treatment.

Exclusion Criteria:

The expected life span is less than 3 months;
Have serious cardiovascular and cerebrovascular diseases, blood coagulation dysfunction, and cannot tolerate surgery;
Allergies to narcotic drugs;
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

Intervention Browse Module

MeSH Terms

ID	Term
D011878	Radiotherapy
D010166	Palliative Care

Ancestor Terms

ID	Term
D013812	Therapeutics
D005791	Patient Care
D006296	Health Services
D005159	Health Care Facilities Workforce and Services

Browse Leaves

Not provided

Browse Branches

Not provided