A Study of Stereotactic Body Radiotherapy (SBRT) and Surgical Stabilization for People With Cancer That Has Spread to the Bone
- Conditions
- Metastatic Cancer
- Interventions
- Radiation: Preoperative Stereotactic Body Radiotherapy (SBRT)
- Registration Number
- NCT05038124
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 39
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Preoperative Stereotactic Body Radiotherapy (SBRT) 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.
- Primary Outcome Measures
Name Time Method risk of major wound complications 6 weeks after preoperative SBRT 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.
- Secondary Outcome Measures
Name Time Method rate of local control 1 year 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.
Trial Locations
- Locations (7)
Memorial Sloan Kettering Bergen
🇺🇸Montvale, New Jersey, United States
Memorial Sloan Kettering Basking Ridge
🇺🇸Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth
🇺🇸Middletown, New Jersey, United States
Memorial Sloan Kettering Cancer Commack
🇺🇸Commack, New York, United States
Memorial Sloan Kettering Westchester
🇺🇸Harrison, New York, United States
Memorial Sloan Kettering Cancer Center (All protocol activities)
🇺🇸New York, New York, United States
Memorial Sloan Kettering Nassau
🇺🇸Uniondale, New York, United States