Local Treatment for Bone Metastases

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: Bone Metastases

Treatments: Radiation: radiation

Study type: Interventional

Funder types: Other

Identifiers

NCT05665439

20221201

Details and patient eligibility

About

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.

Enrollment: 348 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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348 participants in 2 patient groups

local treatment

Experimental group

Treatment:

Radiation: radiation

observation

No Intervention group