Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
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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