NCT05665439

Brief Summary

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.

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
348

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 17, 2022

Completed
10 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 17, 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 (2)

local treatment

EXPERIMENTAL
Radiation: radiation

observation

NO INTERVENTION

Interventions

radiationRADIATION

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

local treatment

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • The expected life span is less than 3 months;
  • Spinal metastatic tumor stability score (SINS) is greater than 7;
  • Spinal cord compression;
  • The patient refused the treatment decision of the integrated team.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Radiation

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
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 17, 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