NCT05665790

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 27, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

March 2, 2023

Status Verified

February 1, 2023

Enrollment Period

2 years

First QC Date

December 18, 2022

Last Update Submit

February 28, 2023

Conditions

Bone Metastases

Outcome Measures

Primary Outcomes (1)

  • Disease control rate at 1 year

    Disease control rate

    1 year

Secondary Outcomes (2)

  • Progression-Free Survival

    1 year

  • Overall Survival

    1 year

Study Arms (3)

radiotherapy

EXPERIMENTAL
Radiation: radiotherapy

palliative surgery

EXPERIMENTAL
Procedure: palliative surgery

no primary leison treatment

NO INTERVENTION

Interventions

radiotherapyRADIATION

radiotherapy

radiotherapy
palliative surgeryPROCEDURE

palliative surgery

palliative surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

RadiotherapyPalliative Care

Intervention Hierarchy (Ancestors)

TherapeuticsPatient CareHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 18, 2022

First Posted

December 27, 2022

Study Start

March 1, 2023

Primary Completion

March 1, 2025

Study Completion

March 1, 2026

Last Updated

March 2, 2023

Record last verified: 2023-02