A Phase III Randomized Trial Comparing Stereotactic Body Radiation Therapy (SBRT) vs Conventional Palliative Radiation Therapy for Painful Bone Metastases
M.D. Anderson Cancer Center
Summary
To compare increasing doses and different treatment schedules of stereotactic body radiation therapy (SBRT) against standard treatment scheduling.
Description
Primary Objectives: • Pain response will be assessed at 2 weeks, 1 month, 3 months and then every 3 months post-treatment and will be determined based on International Pain Consensus Criteria between the two treatment arms. The 3-month pain response will be used as the primary endpoint in trial design and for powering the test of the study's primary hypothesis of pain response. Secondary Objectives: * The local failure rate will be determined by radiographic response after radiation therapy. If the radiographic reports are indeterminate, the local failure rate will be based on second consec…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Patients with pathologic diagnosis of solid primary malignancy with any radiographic report of bone metastases including but not limited to plain x-ray, bone scan, CT scan, MRI, PET/CT scan, PSMA scan, PET fluciclovine scan. The exception is patients diagnosed with multiple myeloma are eligible. * Patients with any pain or discomfort at proposed treatment site. * Patients with life expectancy of 3 months or greater. * Patients able to complete pain assessment and quality of life surveys. * Patients with multiple osseous sites are eligible; however, should not treat more…
Interventions
- DrugRadiation Therapy
Arm 1: standard 8 Gy delivered in a single fraction or 20 Gy delivered in 5 fractions Arm 2: 16 Gy delivered in a single fraction or 27 Gy delivered in 3 fractions prescribed to planning target volume (PTV).
Location
- M D Anderson Cancer CenterHouston, Texas