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Primary Lesion Treatment for Bone Metastases

Primary Purpose

Bone Metastases

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
radiotherapy
palliative surgery
Sponsored by
Shanghai 6th People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    radiotherapy

    palliative surgery

    no primary leison treatment

    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

    First Posted
    December 18, 2022
    Last Updated
    February 28, 2023
    Sponsor
    Shanghai 6th People's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05665790
    Brief Title
    Primary Lesion Treatment for Bone Metastases
    Official Title
    Study on Primary Lesion 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 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

    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
    Non-Randomized
    Enrollment
    400 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    radiotherapy
    Arm Type
    Experimental
    Arm Title
    palliative surgery
    Arm Type
    Experimental
    Arm Title
    no primary leison treatment
    Arm Type
    No Intervention
    Intervention Type
    Radiation
    Intervention Name(s)
    radiotherapy
    Intervention Description
    radiotherapy
    Intervention Type
    Procedure
    Intervention Name(s)
    palliative surgery
    Intervention Description
    palliative surgery
    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: 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.

    12. IPD Sharing Statement

    Learn more about this trial

    Primary Lesion Treatment for Bone Metastases

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