A Phase III Randomized Trial Comparing Stereotactic Body Radiation Therapy (SBRT) vs Conventional Palliative Radiation Therapy for Painful Bone Metastases
NCT06065449 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220
Last updated 2026-01-14
Summary
To compare increasing doses and different treatment schedules of stereotactic body radiation therapy (SBRT) against standard treatment scheduling.
Conditions
Interventions
- DRUG
-
Radiation 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).
Sponsors & Collaborators
-
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Quynh Nguyen, M D · M.D. Anderson Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-01-24
- Primary Completion
- 2027-06-27
- Completion
- 2027-06-27
- FDA Drug
- Yes
Countries
- United States
Study Locations
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