Primary Lesion Treatment for Bone Metastases

NCT ID: NCT05665790

Last Updated: 2023-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-31

Study Completion Date

2026-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Bone Metastases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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radiotherapy

Group Type EXPERIMENTAL

radiotherapy

Intervention Type RADIATION

radiotherapy

palliative surgery

Group Type EXPERIMENTAL

palliative surgery

Intervention Type PROCEDURE

palliative surgery

no primary leison treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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radiotherapy

radiotherapy

Intervention Type RADIATION

palliative surgery

palliative surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai 6th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhao Hui

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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20221202

Identifier Type: -

Identifier Source: org_study_id

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