Local Treatment for Bone Metastases

• Sponsor: Shanghai 6th People's Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05665439
• Collaborator: (none)
• Enrollment: 348
• Arms: 2
• Anticipated Duration (Months): 36

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bone Metastases	Radiation: radiation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 348 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Study on Local 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: local treatment	Radiation: radiation; radiation for patients with newly diagnosed bone metastases or patients with bone metastases after vertebroplasty
No Intervention: observation

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. 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.

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: NCT05665439
• Other Study ID Numbers: 20221201
• 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