Actively Recruiting

Phase 3
Age: 18Years +
All Genders
Healthy Volunteers
NCT06065449

A Phase III Randomized Trial Comparing Stereotactic Body Radiation Therapy (SBRT) vs Conventional Palliative Radiation Therapy for Painful Bone Metastases

Led by M.D. Anderson Cancer Center · Updated on 2026-01-14

220

Participants Needed

1

Research Sites

178 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

To compare increasing doses and different treatment schedules of stereotactic body radiation therapy (SBRT) against standard treatment scheduling.

CONDITIONS

Official Title

A Phase III Randomized Trial Comparing Stereotactic Body Radiation Therapy (SBRT) vs Conventional Palliative Radiation Therapy for Painful Bone Metastases

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with a confirmed diagnosis of solid primary cancer and bone metastases by imaging
  • Patients experiencing pain or discomfort at the planned treatment site
  • Life expectancy of at least 3 months
  • Ability to complete pain and quality of life assessments
  • Up to three bone sites can be treated concurrently; additional sites treated sequentially
  • Patients who had prior surgery for bone metastases can enroll
  • Age 18 years or older
  • Patients may receive systemic cancer treatments during radiation as decided by their doctor
  • Adequate organ and marrow function, including platelets 5,000/mcL
  • Patients with other cancers not interfering with study safety or results may participate
  • Women of childbearing potential and men must agree to use effective contraception during the study
  • Ability to understand and sign informed consent
Not Eligible

You will not qualify if you...

  • Prior radiation therapy to the proposed treatment site
  • Untreated spinal cord compression at the treatment site
  • Unstable fractures at the treatment site unless surgically stabilized
  • Metastases located in the hands or feet
  • Treatment with radioactive isotopes (e.g., Sr 89) within 30 days before enrollment
  • Metastases in cervical, thoracic, or lumbar spine regions (unless invading paraspinal or spine area)
  • Pregnant patients

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

Q

Quynh Nguyen, M D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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