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NCT05665790 Clinical Trial

Primary Lesion Treatment for Bone Metastases

Bone Metastases Clinical Trial

Official title:
Study on Primary Lesion Treatment for Patients With Bone Metastases

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05665790
Other study ID # 20221202
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 2023
Est. completion date March 2026

Study information
Verified date February 2023
Source Shanghai 6th People's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 400
Est. completion date March 2026
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Radiation:
• radiotherapy
radiotherapy
Procedure:
• palliative surgery
palliative surgery

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Shanghai 6th People's Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Disease control rate at 1 year Disease control rate 1 year
Secondary Progression-Free Survival 1 year
Secondary Overall Survival 1 year
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