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Primary Lesion Treatment for Bone Metastases

Sponsor
Shanghai 6th People's Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05665790
Collaborator
(none)
400
Enrollment
3
Arms
36
Anticipated Duration (Months)

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Radiation: radiotherapy
  • Procedure: palliative surgery
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Study on Primary Lesion Treatment for Patients With Bone Metastases
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2025
Anticipated Study Completion Date :
Mar 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: radiotherapy

Radiation: radiotherapy
radiotherapy
Experimental: palliative surgery

Procedure: palliative surgery
palliative surgery
No Intervention: no primary leison treatment

Outcome Measures

Primary Outcome Measures

  1. Disease control rate at 1 year [1 year]

    Disease control rate

Secondary Outcome Measures

  1. Progression-Free Survival [1 year]

  2. Overall Survival [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Shanghai 6th People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhao Hui, Shanghai 6th People's Hospital, Shanghai 6th People's Hospital
ClinicalTrials.gov Identifier:
NCT05665790
Other Study ID Numbers:
  • 20221202
First Posted:
Dec 27, 2022
Last Update Posted:
Dec 27, 2022
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neoplasm Metastasis
Bone Neoplasms
Bone Marrow Diseases

Study Results

No Results Posted as of Dec 27, 2022