A Study of Stereotactic Body Radiotherapy (SBRT) and Surgical Stabilization for People With Cancer That Has Spread to the Bone
Metastatic Cancer
About this trial
This is an interventional treatment trial for Metastatic Cancer focused on measuring Skeletal metastases, Stereotactic Body Radiotherapy (SBRT), Surgical Stabilization, Bone cancer, 21-216
Eligibility Criteria
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
- Concomitant administration of radiosensitizing medication
- Active infection
- Absolute neutrophil count <1.0
- Pregnancy
Sites / Locations
- Memorial Sloan Kettering Basking RidgeRecruiting
- Memorial Sloan Kettering MonmouthRecruiting
- Memorial Sloan Kettering BergenRecruiting
- Memorial Sloan Kettering Cancer CommackRecruiting
- Memorial Sloan Kettering WestchesterRecruiting
- Memorial Sloan Kettering Cancer Center (All protocol activities)Recruiting
- Memorial Sloan Kettering NassauRecruiting
Arms of the Study
Arm 1
Experimental
Preoperative Stereotactic Body Radiotherapy (SBRT)
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.