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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Metastatic Cancer

Intervention / Treatment
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* Radiation: Preoperative Stereotactic Body Radiotherapy (SBRT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is a pilot study to evaluate the safety of preoperative stereotactic body radiotherapy (SBRT) with short-interval surgical stabilization.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preoperative Stereotactic Body Radiotherapy (SBRT)<br>Target lesions will be treated with preoperative SBRT consisting of biologically effective dose (BED10) of 50.4 - 81.6 Gy delivered in either three fractions or a single fraction. Active sparing of the intended surgical approach will be incorporated into the radiation plan by creating an avoidance structure. Surgical stabilization will proceed within 1 week of completion of radiotherapy. Pathologic specimens will be obtained intraoperatively via existing surgical access for histologic and molecular analysis. An optional research MRI with perfusion will be performed within 30 days prior to radiation simulation and within one-week after radiation therapy using 3T scanner. If patients receive radiation simulation at a non-MSK Manhattan site, MRI with Perfusion will not be performed. | Radiation: Preoperative Stereotactic Body Radiotherapy (SBRT)<br>* Target lesions will be treated with preoperative SBRT consisting of biologically effective dose (BED10) of 50.4 - 81.6 Gy delivered in either three fractions or a single fraction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| risk of major wound complications | Major wound complications are defined as reoperation for wound revision, clinically diagnosed surgical site infection, readmission for wound care, or prolonged (>3 weeks postoperatively) active wound care. | 6 weeks after preoperative SBRT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of local control | Failure of local control is defined as a new lesion within the radiation or surgical field, significant progression of an existing lesion, or reoperation or reirradiation due to tumor progression. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skeletal metastases, Stereotactic Body Radiotherapy (SBRT), Surgical Stabilization, Bone cancer, 21-216