Primary Lesion Treatment for Bone Metastases

February 28, 2023 updated by: Zhao Hui, Shanghai 6th People's Hospital

Study on Primary Lesion Treatment for Patients With Bone Metastases

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. The expected life span is less than 3 months;
  2. Have serious cardiovascular and cerebrovascular diseases, blood coagulation dysfunction, and cannot tolerate surgery;
  3. Allergies to narcotic drugs;
  4. The patient refused the treatment decision of the integrated team.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: radiotherapy
Radiation: radiotherapy
radiotherapy
Experimental: palliative surgery
Procedure: palliative surgery
palliative surgery
No Intervention: no primary leison treatment

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: 1 year
1 year
Progression-Free Survival
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai 6th People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2023

Primary Completion (Anticipated)

March 1, 2025

Study Completion (Anticipated)

March 1, 2026

Study Registration Dates

First Submitted

December 18, 2022

First Submitted That Met QC Criteria

December 23, 2022

First Posted (Actual)

December 27, 2022

Study Record Updates

Last Update Posted (Actual)

March 2, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20221202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bone Metastases

Clinical Trials on radiotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ethiopia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe