A Study of Stereotactic Body Radiotherapy (SBRT) and Surgical Stabilization for People With Cancer That Has Spread to the Bone

A Pilot Study to Assess the Safety and Efficacy of Preoperative Stereotactic Body Radiotherapy for the Treatment of Metastatic Disease in Bone Requiring Surgical Stabilization

The purpose of this study is to test the safety of stereotactic body radiation therapy (SBRT) followed by surgical stabilization within 1 week. All participants will have metastatic cancer in the bone (bone metastases), and they will be at risk of pathologic fracture (broken bone caused by a disease). Another purpose of this study is to see if the treatment approach of SBRT followed by surgical stabilization within 1 week prevents cancer from returning to the bone.

Inclusion Criteria:

• Diagnosis of metastatic cancer with radiologic evidence of skeletal metastases
• Treatment target involving humerus, radius, pelvis, sacrum, femur, or tibial diaphysis
• Age at enrollment ≥18 years
• Life expectancy >3 months
• Ability to tolerate radiation simulation and treatment with immobilization of involved anatomic site
• Surgical candidate, as determined by the treatment team
• Ability to obtain informed consent from patient or legally authorized representative in the setting of patient with impaired decision-making capacity.
• Must agree to practice an effective contraceptive method (for those with reproductive potential)

Exclusion Criteria:

• Prior radiotherapy to the treatment site
• Prior surgery involving the treatment site
• Tumor volume or distribution precluding effective SBRT
• Expected skin dose at the operative site ≥9 Gy
• Imminently impending fracture requiring immediate stabilization surgery
• Involvement of proximal tibia
• Autoimmune connective tissue disorder
• Administration of radiosensitizing medication 3 days before, during, and 3 days after RT
• Active infection
• Absolute neutrophil count <1.0
• Pregnancy