Local Treatment for Bone Metastases

NCT ID: NCT05665439

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

348 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 randomized controlled study to study the effect of different local treatment on disease control, quality of life, economic cost and even survival period of patients by randomly giving local radiotherapy or observation to patients with newly diagnosed bone metastases or patients with bone metastases after vertebroplasty.

Detailed Description

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Conditions

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Bone Metastases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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local treatment

Group Type EXPERIMENTAL

radiation

Intervention Type RADIATION

radiation for patients with newly diagnosed bone metastases or patients with bone metastases after vertebroplasty

observation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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radiation

radiation for patients with newly diagnosed bone metastases or patients with bone metastases after vertebroplasty

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

1. Patients who are definitely diagnosed as malignant tumor by pathology or cytology;
2. At least one bone metastasis site;
3. Aged over 18;
4. ECOG:0-1;
5. The pain score is less than 5 or after vertebroplasty within 1 month.

Exclusion Criteria

1. The expected life span is less than 3 months;
2. Spinal metastatic tumor stability score (SINS) is greater than 7;
3. Spinal cord compression;
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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20221201

Identifier Type: -

Identifier Source: org_study_id

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