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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial investigates the use of stereotactic body radiation therapy (SBRT) compared to conventional palliative radiation therapy for people with painful bone metastases caused by solid tumors. The study aims to find out which radiation schedule and dose better relieve pain, with pain response measured at multiple time points up to several months after treatment. The research also evaluates treatment safety, survival, and quality of life outcomes. Participants receive radiation therapy in one of two groups: standard dose or high dose. The standard dose group may get 8 Gy in one session or 20 Gy over five sessions, while the high dose group may receive 16 Gy in one session or 27 Gy over three sessions. Radiation treatments are given daily over consecutive days, not counting weekends or holidays, depending on the assigned schedule. During the study, participants will have their pain assessed at 2 weeks, 1 month, 3 months, and then every 3 months after treatment. Researchers will also review imaging to check for cancer progression, monitor pain medication use, record any additional treatments or surgeries, and track side effects. Quality of life surveys will be completed, and adverse events will be followed for about one year. The total time participants are involved depends on follow-up schedules and treatment response.
CONDITIONS
Brief 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 pathologic diagnosis of solid primary malignancy with radiographic evidence of bone metastases
- Patients experiencing pain or discomfort at the proposed treatment site
- Patients with a life expectancy of 3 months or greater
- Patients able to complete pain assessment and quality of life surveys
- Patients with multiple bone metastases may participate but should not have more than three treatment sites at the same time
- Patients with prior surgery for bone metastases are eligible
- Patients aged 18 years or older
- Patients can receive systemic therapies during radiation as per physician's discretion
- Patients must have adequate organ and marrow function
- Patients with another malignancy that does not interfere with trial assessments are eligible
- 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...
- Patients with prior radiation therapy to the proposed treatment site
- Patients with untreated spinal cord compression at the treatment site
- Patients with unstable pathologic fractures at the treatment site unless stabilized
- Patients with metastases to the hands or feet
- Patients treated with radioactive isotopes within 30 days before study entry
- Patients with spinal metastases in the cervical, thoracic, or lumbar spine (unless the primary tumor invades the spine area)
- Pregnant patients are not eligible
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 to 5 days depending on treatment arm
Participants receive radiation therapy consisting of either standard dose or high dose schedules for painful bone metastases.
1 radiation treatment a day for 3 days or 5 days, or 1 radiation treatment given on 1 day
Duration - Up to 1 year
Participants are monitored for pain response, adverse events, and quality of life after radiation therapy.
Visits at 2 weeks, 1 month, 3 months, and every 3 months post-treatment
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
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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